Peroneal Stimulation for Foot Drop After Stroke a Systematic Review

Introduction

Stroke is one of the almost meaning causes of disability in adults. Damage to the motor cortex or corticospinal tract often results in contralateral hemiplegia with pregnant persistent distal weakness. Patients with this pattern of weakness are often unable to actively dorsiflex the human foot during the swing stage of gait, which is referred to equally drop foot. This gait damage can result in compensatory motility patterns, slowed gait velocity, express functional mobility, and increased chance of falls.^1–3

The traditional treatment for persistent drop foot is an ankle foot orthosis (AFO) that holds the foot in a neutral position. The most common blazon of AFO is a solid plastic caryatid, although it may be fabricated of metal or blended materials, with any number of modifications, including an articulated or hinged ankle joint. In general, AFOs have been institute to back up talocrural joint dorsiflexion during swing stage and improve knee stability in early stance stage in individuals with drop foot.^2,4 All the same, at that place are several meaning disadvantages of AFOs such as limited ankle mobility that may contribute to the development of contracture^4,5 and difficulty with continuing from a chair,^half-dozen forth with discomfort and unfavorable aesthetics.^vii

An alternative to the more traditional AFO is the use of functional electric stimulation. Foot driblet stimulators (FDS) use functional electric stimulation to stimulate the common peroneal nerve, activating the muscles that dorsiflex the pes during the swing phase of gait. The outcome of FDS or an AFO on gait can be measured in several ways, but conflicting terms accept previously been used in the literature.^viii,9 Nosotros have attempted to provide clear operational definitions that describe the scope and timing of comparison,^x as illustrated in Figure 1. The firsthand effect refers to changes in gait that occur when initially wearing the device. A training effect higher up and beyond the immediate issue may occur equally the patient uses the orthosis or FDS over time. The therapeutic effect refers to improvements in walking seen even without wearing an orthosis or FDS and may effect from changes in neural plasticity, peripheral strength, cardiopulmonary system, or other systems. The full effect refers to the changes in gait that occur over fourth dimension, and encompasses both the immediate and training effects.

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Figure 1. Illustration of comparisons of event of ankle foot orthosis (AFO) or foot driblet stimulator (FDS) on gait.

The results of past FDS studies in stroke have had generally positive results on these different effects, using quasi-experimental and within-discipline study designs.^eleven–13 Increased gait speed has been institute consistently in patients with stroke comparing no orthotic with use of both FDS^{9,14–sixteen} and AFO.^17,18 Minor, short-term studies using a inside-subjects comparing of AFO and FDS in stroke institute that both devices increased gait speed later eight weeks.^11,13 The only long-term study of FDS on gait speed institute a pattern of significant improvement fifty-fifty at 11 months in participants with a nonprogressive disorder (ie, stroke).⁸ The only randomized controlled trial on AFO use in stroke found no meaning comeback in gait speed after iii months.¹⁹ To date, no randomized controlled trials have straight compared surface FDS with AFO in people with drop human foot later on stroke. However, a randomized controlled trial that compared an implantable peroneal nerve stimulator showed significantly increased gait speed compared with the AFO/control group.²⁰

The Functional Ambulation: Standard Treatment versus Electric Stimulation Therapy (FASTEST) trial was designed to compare FDS and AFO for driblet foot among people ≥three months subsequently stroke, with a gait speed ≤0.8 grand/s. This was a multicenter, randomized controlled, unmarried-blinded trial. We hypothesized that afterward 30 weeks, participants randomized to the FDS grouping would demonstrate greater improvement in gait speed than participants randomized to the AFO group. This hypothesis was based on the anticipated full device furnishings, encompassing both the immediate and preparation effects, from the results of previous studies showing positive long-term effects of FDS on gait speed.^viii,20 Other comparisons illustrated in Figure 1 were besides assessed.

Methods

A detailed description of the trial design and the methods have been published previously,¹⁰ with a brief summary provided here. Participants ≥iii months subsequently stroke with gait speed ≤0.8 m/s were randomized to xxx weeks of wearing either a surface FDS (treatment group) or a standard AFO (control group). At 30 weeks, the command group crossed over to receive an FDS and was followed for an additional 12 weeks, whereas the original treatment grouping continued to use their FDS. This commodity reports on the primary and secondary outcomes at 30 weeks, before crossover.

Participant Screening and Randomization

Participants were recruited at xi clinical sites beyond the United States (run into the online-simply Information Supplement). Each site obtained Institutional Review Board blessing, and informed consent was obtained before any report procedures.

Inclusion and exclusion criteria are presented in Table 1. The screening process included assessment by an independent orthotist and a physical therapist to verify that each participant demonstrated drop pes requiring an AFO, and to make up one's mind whether his or her electric current AFO was appropriate based on all-time practice points as described by a consensus document published by the International Society for Prosthetics and Orthotics,²¹ too every bit Medicare reimbursement guidelines. If the participant did not have an AFO, a new custom-made AFO was prescribed by the site team and paid for by the sponsor. If the current AFO needed modification, those modifications were prescribed by the site team and paid for by the sponsor. The specific type of AFO (eg, solid ankle, hinged, etc) prescribed for each participant was left to the discretion of the study team of each site. This process ensured that all subjects had an appropriate AFO when needed during the study, and occurred before randomization.

Table 1. Eligibility Criteria

Inclusion Criteria	Exclusion Criteria
At least i stroke ≥3 mo before study enrollment, resulting in drop foot	Fixed talocrural joint contracture at ≥5 degrees of plantar flexion in the hemiplegic leg with the human knee extended
Ankle dorsiflexion response with test stimulation in sitting and standing, and acceptable talocrural joint and knee stability during gait with test stimulation	Pain in the afflicted leg, rated ≥four on a 10-betoken visual analog scale
Medically stable	Participating in PT, OT, new exercise program, or any other interventional clinical research studies without the sponsor'southward approval
Score ≥24 on the Mini Mental State Examination (MMSE), or have a competent caregiver if <24.	Botulinum toxin to the hemiplegic leg or arm within the past half dozen wk or planned during the course of the written report
Historic period ≥18 y or older	Expectation of a pregnant change in oral medications for spasticity
Able to walk ≥10 meters with a maximum of 1 person assist	Complete lower extremity hemisensory loss
Self-selected gait speed ≤0.80 m/s without orthotic effect	Utilise of whatever FDS device for foot drop for an accumulative >3 h within the last 6 mo earlier study enrollment
	Whatever electrical or metallic implant; significant swelling/edema in the lower leg; chronic skin bug or malignant lesion in close proximity to the site of FDS stimulation; meaning or program on becoming pregnant; unstable seizure disorder; orthopedic conditions that would touch airing; major untreated depression

Once study eligibility was confirmed, random group assignment was performed by the sponsor using a web-based application prepared past the report statistician (S.Due west.). Covariate adaptive randomization²² was used to ensure balanced group allocation at each site for age and time afterward stroke and known demographic confounders, inside 4 subgroups: 3 to 6 months after stroke, >6 months after stroke, <65 years of age, and ≥65 years of historic period or Medicare casher. For each new participant, the Web-based application determined imbalance corresponding to its covariate characteristics based on cumulative distribution of assignments up to that point. If there was assignment imbalance, the subject was allocated to the nether-represented group with a P value of 2/3; otherwise, the bailiwick was randomized with equal probability.

Interventions

During the first 6 weeks of the study, both groups received 8 dose-matched sessions of physical therapy (PT) led by a licensed physical therapist who had received training and competency assessment in the apply of FDS. Regardless of group assignment, the starting time two to 4 therapy visits focused on education on device use (AFO or FDS), initial gait grooming, and an individualized home exercise programme. The remaining sessions of PT focused on gait training with the assigned device.

FDS Group

The FDS used in this study was the NESS L300 Foot Drop Organisation, manufactured by Bioness Inc. (Valencia, CA). The L300 comprised a functional stimulation cuff with integrated stimulation unit and electrodes, a control unit, and an in-shoe pressure sensor. The unit is initially configured by a clinician using a handheld calculator interface. The force per unit area sensor detects heel off and initial contact events during gait. Information technology transmits wireless signals to the stimulation cuff, which initiates/pauses the stimulation of deep and superficial branches of the peroneal nervus via 2 surface electrodes. The pes dorsiflexors and evertors are, therefore, activated to ensure foot clearance during the swing phase and prevent excessive ankle inversion during early stance, respectively.

Standardized protocols derived past the sponsor from >v years of market experience were used by all sites for initial plumbing equipment of the FDS, gait training, wearing schedule, home exercise programme, and participant pedagogy. Written peel care guidelines were reviewed and issued to the participant during the initial plumbing fixtures and reviewed throughout the training period.

AFO Group

Teaching on use, care, gait training, home exercise program, and maintenance of the AFO was provided, along with a wearing schedule when needed (eg, new AFO). It is impossible to implement a sham control treatment for FDS because the participant tin feel the stimulation and see their foot move. Moreover, some form of drop pes intervention is necessary for rubber walking. Therefore, control participants received surface sensory stimulation with a transcutaneous electric nerve stimulation (TENS) device at each PT visit during the first 2 weeks. TENS intensity was set up at the lowest stimulation level that yielded a sensory response without motor response, at a frequency of 100 pps and duration of 200 µsec.

Outcomes

Repeated outcome measures were obtained at baseline and later 6, 12, and 30 weeks. For baseline and xxx-week sessions, including testing both with and without the device, meet Figure one. Well visit follow-ups were performed at weeks 16, 20, and 24, which included autumn questionnaires and pare/AE cess only.

Result testing was performed by physical therapists blinded to group assignment. The therapists all received grooming and passed an on-site competency examination for consistency in outcomes assessment. To maintain blinding, a large piece of vinyl material was secured over the lower leg and shoe on the involved lower extremity to muffle the device and pressure sensor. All subjects wore an FDS control unit on their belt, regardless of group consignment.

Chief Issue

Comfortable and fast walking speed were assessed was assessed with a 10-meter walk test.²³ Walking speed has been shown to be an important predictor of customs ambulation, functional condition, and survival.^24–26 The about commonly used assistive device at the fourth dimension of assessment was used and documented, forth with documentation of the amount of assistance provided.

Secondary Outcomes

Additional outcome measures were included, encompassing the latitude of the International Classification of Role model.²⁷ These included a measure of trunk structure and function (lower extremity Fugl-Meyer), several activity measures to assess functional mobility (Timed upwardly and go), walking endurance (6-minute walk test [6MWT]), and balance (Berg balance scale; Functional reach test), and a participation-level measure (Stroke Impact Scale). All result measures are valid and reliable in people with stroke.^23,28–36

Step activity monitors were worn on the uninvolved leg during all waking hours for seven consecutive days in weeks vi and 24 to quantify the amount of walking at home and in the community (StepWatch by Orthocare Innovations, LLC).³⁷

A user satisfaction survey^xvi was completed at week 12 (afterwards completion of PT sessions) and again at week 30 in both groups. This 12-detail survey had a total range of scores from 0 to 24, with a higher number indicating greater satisfaction with the device.

Adverse Events and Falls

The cumulative frequency and severity of adverse events (AEs), number of events per field of study, and percentage of subjects experiencing an AE were reported from randomization to the thirty-calendar week visit. Autumn incidence was obtained by self-report from participants and their caregivers retrospectively half-dozen months earlier baseline and at each written report visit during the 30-week intervention period. Circumstances regarding each fall were nerveless, including any injury or medical attention received.

Statistical Analysis

Sample Size and Ability Analysis

The original power analysis for this study resulted in the plan to enroll 176 eligible participants, assuasive for a 25% dropout rate, which would result in 132 participants who would consummate the study. This was estimated to provide lxxx% power to detect a clinically meaningful (0.1 m/s)³⁸ departure in walking speed change between groups using a 2-sample t test with a 2-sided 0.05 level. After the offset planned interim analysis (September 2011), the enrollment goal was increased to 206. This increase immune for (1) the improver of a primary hypothesis for a subgroup of persons with initially severe gait (<0.4 m/sec gait speed), and (two) the reduction of the risk of typeII errors on several secondary outcomes. Equally a result of favorable trends in outcomes for participants with astringent gait impairment, a hypothesis was added that participants in this subgroup randomized to the FDS group would demonstrate greater improvement in gait speed than those randomized to the AFO group. The sponsor elected to close enrollment at 197 participants.

Data Management and Quality

A secure Web-based electronic data capture arrangement (Medidata Rave) was used for clinical data collection and management. Third party monitors performed regular visits at each site to review and verify all study data in source documents.

Data Analysis

Differences in demographic and baseline variables between groups were analyzed using t exam or χ² test. Variables found to be significantly unlike between groups were used as covariates in the concluding analyses, in add-on to the prespecified covariates of report site and whether a new AFO prescription was provided at study entry.

The chief intent-to-treat analysis involved 2 tests: 1 for the entire sample and the other for the astringent subgroup. The study-broad fault rate was controlled at the 0.05 level by applying the Hochberg footstep-up process.³⁹ Each statistical test was based on the Fisher combination of two P values: one from earlier and the other from after the starting time interim analysis. Both P values were derived from a linear model investigating whether the groups differ in walking speed improvement from baseline to xxx weeks, subsequently controlling for the aforementioned covariates.

Outcomes for participants who could non complete the thirty-week evaluation were imputed by a regression model that takes into account participant dropout bias (described in protocol article).¹⁰ In addition, Wilcoxon rank-sum tests were conducted to compare secondary outcomes between the 2 groups. For simplicity, but the completers were analyzed, and there were no adjustment for covariates. However, the family unit-wise error rate for all secondary hypotheses testing was controlled at 0.05 level based on Holm step-downwardly procedure,⁴⁰ which rejects a hypothesis only if its P value and each of the smaller P values are less than their corresponding critical values.

Results

Recruitment, Screening, and Randomization

More than 1200 potential subjects were screened by phone, via chart review, or in person. After initial screening, 389 subjects signed informed consent and participated in further in-person screening (Figure 2). A total of 197 participants were enrolled and randomized.

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Figure 2. Consolidated standards of reporting trials (Consort) diagram. AFO indicates ankle foot orthotic; FDS, human foot drop stimulator; and SAE, serious adverse event.

Participant Characteristics

Participant characteristics at baseline with betwixt-group comparisons are presented in the online-merely Data Supplement. The only pregnant differences between groups were in categories of sex (greater percentage of females in the treatment group) and stroke type (greater percentage of ischemic stroke in handling group). Both were used as covariates in all subsequent analyses. Information technology is notable that 118 of 197 (60%) participants received a new or modified AFO at study entry. A description of type of AFO at each site is provided in the online-just Data Supplement.

Master Outcome: Gait Speed

At xxx weeks, both comfy and fast gait speed improved significantly within both the FDS and AFO groups for total upshot, as well as training and therapeutic effect (P<0.001 for all). In addition, the immediate consequence was also significant within groups (P<0.001). The specific alter values are presented in Table 2 for the entire sample and in the online-only Data Supplement for the severe subgroup. Nevertheless, no significant differences were found betwixt groups for comfy gait speed improvement for either the entire sample (0.xv±0.fourteen vs 0.14±0.16; P=0.78 with Fisher combination exam) or in the severe subgroup (0.11±0.14 vs 0.11±0.11; P=0.xvi with Fisher combination examination). Figure 3 illustrates the trajectory of change of the unabridged sample for comfortable gait speed between groups over time, for both the training upshot and the therapeutic outcome. No sex-based or racial/ethnic-based differences were present for the master effect.

Table two. Alter in Outcomes by Treatment Group

		Overall (n=197)	Control (n=98)	Handling (due north=99)	P Value for Betwixt Groups
Change in comfy gait speed, m/s	Long-term device effect	0.15±0.xv*	0.15±0.14*	0.14±0.sixteen*	0.749
	Immediate device effect	0.08±0.11*	0.09±0.12*	0.07±0.10*	0.180
	Training consequence	0.07±0.11*	0.06±0.11*	0.08±0.12*	0.379
	Therapeutic effect	0.10±0.14*	0.09±0.14*	0.10±0.14*	0.460
Change in fast gait speed, m/southward	Long-term device effect	0.15±0.17*	0.17±0.18*	0.13±0.xvi*	0.125
	Immediate device event	0.07±0.13*	0.09±0.fifteen*	0.05±0.11*	0.018
	Training effect	0.08±0.fourteen*	0.07±0.15*	0.08±0.fourteen*	0.711
	Therapeutic effect	0.05±0.xiv*	0.05±0.14*	0.06±0.xiii*	0.466
Modify in 6-min walk distance, m	Long-term device effect	44.7±56.9*	48.6±51.1*	40.9±62.i*	0.341
	Firsthand device effect	22.5±41.two*	25.8±42.3*	19.iii±39.9*	0.276
	Training effect	22.ii±44.iv*	22.9±42.five*	21.5±46.3*	0.834
	Therapeutic effect	13.seven±46.ane*	xi.nine±41.9*	xv.6±50.1*	0.576
Change in Timed upwards and go (TUG) test, s	Long-term device outcome	−five.16±17.66*	−4.38±21.37*	−v.93±xiii.06*	0.539
	Immediate device event	−3.22±13.01*	−iii.19±fourteen.34*	−3.26±eleven.61*	0.970
	Training issue	−ane.93±13.64*	−ane.nineteen±xv.52	−2.67±11.51*	0.447
	Therapeutic effect	−i.27±xi.95	−0.01±13.12	−2.52±ten.58*	0.140
Change in Berg Residuum Scale score	Long-term device effect	2.86±v.46*	3.75±4.62*	1.97±6.08*	0.022
	Immediate device event	one.51±iv.07*	2.12±4.21*	0.92±three.86*	0.039
	Grooming effect	1.34±4.79*	1.64±four.25*	1.06±five.27*	0.397
	Therapeutic outcome	1.85±iv.87*	2.05±4.57*	one.65±five.16*	0.564
Change in functional reach altitude, inches	Long-term device effect	1.10±6.67*	1.09±6.30	1.12±7.05	0.969
	Firsthand device effect	0.61±half-dozen.43	0.83±v.40	0.39±7.32	0.631
	Preparation effect	0.49±vi.16	0.25±half-dozen.48	0.73±5.84	0.586
	Therapeutic outcome	0.15±7.03	0.28±6.84	0.03±seven.25	0.800
Change in Fugl-Meyer Lower Extremity score	Long-term device outcome	0.71±3.42*	i.04±3.26*	0.38±iii.56	0.178
	Immediate device upshot	0.37±ii.97	0.58±3.31	0.16±two.59	0.323
	Training event	0.34±3.22	0.46±3.60	0.22±two.81	0.607
Alter in Stroke Impact Scale (Sister) participation scores	Long-term device result	7.79±17.83*	vii.09±17.24*	eight.48±xviii.47*	0.587
	Immediate device effect	one.56±14.86	1.51±14.81	ane.62±14.99	0.960
	Training outcome	6.23±16.19*	5.59±17.85*	six.86±14.41*	0.581
Alter in SIS mobility scores	Long-term device event	5.18±fourteen.78*	iii.19±fourteen.thirty*	vii.14±15.04*	0.061
	Firsthand device effect	−1.27±11.17	−2.63±eleven.77*	0.08±ten.42	0.088
	Training effect	vi.45±xiii.51*	5.83±thirteen.26*	7.06±13.79*	0.523

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Effigy iii. Trajectory of change in outcome measures week 0 to 30, illustrating the training effect (solid foursquare and circumvolve) and the therapeutic issue (open foursquare and circle). AFO indicates talocrural joint foot orthotic; and FDS, foot drop stimulator.

Secondary Outcomes

All outcome measures had similar patterns of alter, with significant improvements noted within both groups but no significant between-group differences. Figure 4 illustrates comparisons for total orthotic consequence, immediate orthotic effect, training effect, and therapeutic effect for several of the gait outcomes. Specific values for these changes in the entire sample and the severe subgroup are presented in the online-only Data Supplement. No between-group differences were noted in the number of steps per twenty-four hour period, as measured with the step activity monitors at week 6 (1891 steps per day in command group; 2092 steps per day in handling group) or week 30 (2069 steps per day in control group; 2369 steps per 24-hour interval in treatment group).

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Figure 4. Illustration of total effect (immediate orthotic upshot plus preparation consequence) and therapeutic effect in talocrural joint foot orthotic (AFO) and foot drop stimulator (FDS) groups for several outcome measures at thirty weeks: change scores for comfortable gait speed (A), fast gait speed (B), timed up and go (C), 6-minute walk altitude (D).

User Satisfaction

The total user satisfaction survey score measured at week 12 (later completion of PT sessions) was significantly higher in the treatment group than the control group (21.9±2.iv versus xix.0±4.4; 95% confidence interval of hateful departure, i.71–3.87; P<0.001), and these differences persisted at week 30 (21.8±2.9 versus 19.1±4.0; 95% conviction interval, 1.64–3.74). Analysis of scores for individual items is presented in the online-only Information Supplement.

Prophylactic/AEs

Twenty serious AEs were reported, but none were related to the study or the device. The frequency and severity of AEs are summarized in the online-but Data Supplement. The total number of AEs was higher (P<0.01) in the treatment group: 82 FDS participants reported a full of 219 AEs, 130 (59%) of them related to device/procedure compared with 61 AFO participants who reported a full of 147 AEs, 50 (34%) of them related to device/procedure. Still, nearly all of the related AEs were of mild severity (92% for FDS and 96% for AFO). Predictable skin irritation bug accounted for 51 (40%) of study-related AEs in the treatment group. The number of participants who brutal in the 2 groups during the written report menstruation was non significantly unlike, with a greater number of falls experienced in the control grouping.

Word

FASTEST is the largest randomized controlled trial comparison FDS and AFOs in persons with stroke to appointment. The hypothesis that participants randomized to the FDS grouping would demonstrate greater comeback in gait speed than participants randomized to the AFO grouping was not supported. Rather, the AFO and FDS groups both made statistically and clinically meaning gains in gait speed and other outcomes across all domains of the International Classification of Function model. The observed gains were likely considering of a blended effect of the devices, motor learning, and the PT intervention provided at the showtime of the written report.

There may exist several reasons why there were no betwixt-group differences in the full issue or other comparisons contrary to our hypotheses. To protect against pick bias favoring FDS, all participants were evaluated before randomization to ensure that their current AFO was safety and effective. The fact that more than than half (60%) of participants enrolled in this report required a new or modified AFO was unexpected considering the participants all had drop foot, were community dwelling, and had completed their PT earlier enrollment. Withal, a majority did non have an AFO that met minimal standards for fitness and safe. Therefore, many individuals in the standard care control group received either a new or modified brace before randomization in addition to receiving the PT intervention. This might have contributed to the unexpected improvements in gait and other outcomes in this group.

Participants in both groups received eight PT sessions over the first half-dozen weeks focused on gait training and an individualized home exercise program. As evidenced in Figure 3, the impact of PT may accept been particularly prominent in the showtime 12 weeks afterwards randomization. The PT sessions were essential for initial didactics and gait grooming with the FDS to maximize effectiveness and safety of gait as well equally for monitoring for compliance and peel intendance. The beneficial impact of PT in persons with chronic stroke is well known.^41–43 Although potentially blunting differences between groups, our results support the value of PT every bit part of the initial deployment and management of either FDS or AFO for foot drib in patients with stroke.

The control/AFO group likewise received TENS during the PT treatment sessions in an attempt to provide sensory nerve stimulation every bit a sham treatment compared with the motor and sensory stimulation experienced with FDS. It is possible that TENS itself contributed to increased gait speed in the control grouping. Although a systematic review and meta-assay stated there was insufficient evidence to make conclusions regarding the effectiveness of TENS,⁹ several studies accept shown increased gait speed afterwards the use of TENS to the lower extremity combined with gait preparation in people with chronic stroke.^44–48

It is notable that the firsthand effect was statically significant for both devices. This finding speaks to the immediate impact of both devices and the degree of limitation that foot drib entails in persons after stroke and is consistent with other studies that have examined this effect with FDS.^14,16 It is expected that learning to walk with a new device occurs over time, equally has been shown with other studies of FDS without a control or comparison group.^{viii,13,15,16} In the context of this trial, we defined a total effect of device use over time as distinct from a therapeutic result that reflects alter in walking without whatever device. All the same, these factors are non mutually exclusive. The therapeutic effect of functional electrical stimulation was confirmed with a meta-analysis examining the results of v studies on gait speed in patients with stroke,⁹ forth with more than recent studies.⁸

Although AFOs are normally used to address foot drop subsequently stroke, there is a surprisingly small amount of quality research to support the apply of AFOs in neuromuscular disorders as noted by a recent review of literature.⁴⁹ The single randomized controlled trial that has been published on this topic did not detect clinical or significant improvements in gait speed when comparing a standard polypropylene AFO (fix in five° of dorsiflexion) with a placebo AFO that allowed normal range of motion.¹⁹ However, merely 50% of patients in that study complied with wearing the AFO, which seems to confirm the bug related to prestudy AFO use in our report.

With regard to AFO alone, there is lilliputian to no data on the biological basis for effectiveness in persons with stroke. Kinematic studies have demonstrated the biomechanical advantage at the ankle, genu, and hip by passively supporting dorsiflexion during the swing phase of gait with an AFO.^2,4 We did notice a significantly improved full device consequence for the Berg remainder calibration in the command AFO group compared with the FDS group. Even so, the magnitude of modify was below the minimal detectable alter (beyond measurement variation) in older adults⁵⁰ and less than the smallest real divergence in people with chronic stroke.⁵¹ The AFO may have mechanical attributes that are amenable for amend performance of this exam, peculiarly in single limb stance activities, but the lack of departure in falls betwixt groups indicates that this solo finding may have little clinical significance. The biological basis of the therapeutic effect observed in the AFO group in this written report could be increased in peripheral muscle strength (unlikely given the relative immobilization of the ankle), neural plasticity, or improved cardiopulmonary conditioning. However, our written report is not designed to distinguish these or other mechanisms. It should be noted that the 2005 Stroke Rehabilitation Guidelines from the American Heart Association make clear that AFOs should not supersede functional exercise directed at regaining muscle forcefulness and control, which suggests express therapeutic benefit.⁵²

With regard to FDS, there is a more all-encompassing exam of the underlying biological effect.⁵³ Peroneal nerve stimulation has been found to change surface electromyographical action,⁵⁴ enhance cortical excitability,⁵⁵ and, in the upper extremity, modify activity on functional magnetic resonance imaging.⁵⁶ The latter study, and others,⁵⁷ likewise suggest that the combination of voluntary musculus contraction and functional electrical stimulation may exist more effective in activating the cortex. Although no similar data exist for AFO, the relatively immobilizing event of an ankle brace would be theoretically less desirable than the move allowed with FDS use. In our written report, a greater number of AEs were reported in the treatment group. Skin irritation from the FDS electrodes was an anticipated cistron that has been previously reported,⁵⁸ but the majority of the AEs in both groups were of mild severity.

Although participants in both groups in our study had equivalent improvement in functional outcomes, there was a significant difference in the user satisfaction scores. This is consistent with multiple previously published studies with subjective reports or surveys favoring FDS over AFO.^{11,12,58–sixty} Our user satisfaction survey was identical to that previously used by Hausdorff and Ring,¹⁶ just that specific survey has not been previously used to compare FDS and AFO. Poor compliance with AFOs has been reported in people with human foot drop,^19,61 and may have been a factor leading to the lack of adequate use of AFOs in many of the participants at enrollment into the study. Considering an impressive improvement was seen with both devices, and most all AEs were mild and expected, the issue of compliance may be the unmarried most importance factor in the functional improvements expected over long-term use of a device for foot drib. Although the number of steps per 24-hour interval assessed at 2 points during the trial was similar between groups, this written report was not long enough to show the impact of compliance over a long term. An economic comparison of long-term use of AFO versus FDS would also be valuable only was outside the scope of this trial.

The average historic period of participants in this study was 61 years, which is comparable to the historic period of other large clinical trials in stroke rehabilitation,^62,63 and an average of iv.5 years afterwards stroke. Nonetheless, the average historic period for people hospitalized for stroke is seventy years, and the incidence of stroke increases with historic period.⁶⁴ Age is well known equally a predictive cistron of mortality and initial recovery,⁶⁵ although less is known about the influence of age on rehabilitation in the chronic phase of stroke.

A wide range of outcome measures were used in this trial, with noun efforts toward standardization and blinding of assessments. Yet, other outcome measures may also be meaningful in comparing FDS with AFO based on previous research, including obstruction avoidance,⁶⁶ ankle dorsiflexion strength,⁶⁷ and cortical pathways used for musculus activation.⁵³ Furthermore, the evolution of a validated measure of user satisfaction is important to fairly capture the factors that lead to long-term compliance and the subjective experience of the individual with drop foot from stroke.

Conclusion

We institute that an AFO or an FDS used for 30 weeks after stroke had like effects on gait speed. Nonetheless, with upshot sizes ranging from 0.93 to 1.00, the FASTEST trial provides encouraging evidence that rehabilitation interventions for drib foot tin can accept a positive impact even many years later stroke. These clinically relevant improvements in gait speed and other functional outcomes have important implications for healthcare reform and insurance coverage policy.

Acknowledgments

We thank the site Principal Investigators, Medical Directors, and Study Coordinators: Academy of Cincinnati, UC-Wellness Drake Center, Cincinnati OH: Brett Kissela, Md; Johnny Wilkerson, BS; Lynn Sprafka, RN CCRP; Weill Cornell Medical Center, New York, NY: Laura DiStasi; University of Kansas Medical Center, Kansas City, KS: Linda Ladesich, MD; Mamatha Pasnoor, Physician; Rupali Singh, PT; Academy of Utah, School of Medicine, Common salt Lake Urban center, UT: Steven R. Edgley, MD, Mary South. Annis Pautler; National Rehabilitation Hospital, Washington DC: Kathy Brady, PT, NCS; Alexander Dromerick, MD; Brooks Center for Rehabilitation Studies, Jacksonville, FL: Trevor Paris, MD; Brooke Hoisington, PT; Molly Dunn PT; Sharp Rehabilitation Center, San Diego, CA: Jerome Stenehjem, MD; Sara Settle, PT, NCS; University of Texas Southwestern, Dallas, TX: John Thottakara, Md; Cindy Dolezal, PT; St. Charles Hospital & Rehabilitation, Port Jefferson, NY: Jun Zhang, Doctor; Mike Apostoli; Rancho Los Amigos National Rehabilitation Center, Downey, CA: Ziyad Ayyoub, Doc; Bob Boucher, PA-C; Long Embankment Memorial Medical Center, Long Embankment, CA: Diemha Hoang, MD; Wendy Lazouras, DPT; Medical Safety Monitor: Richard Zorowitz, MD, Johns Hopkins Bay View Medical Heart, Baltimore, Dr..

Sources of Funding

This clinical trial was funded by Bioness Inc.

Disclosures

J. Ginosian, MS, J. Feld, DPT, and Grand. McBride, DPT, were employed past Bioness Inc during the study period; Dr Wu was paid every bit a statistical consultant by Bioness Inc. The other authors take no conflict to report.

Footnotes

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Source: https://www.ahajournals.org/doi/abs/10.1161/strokeaha.111.000334

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