Feasibility and Preliminary Efficacy of Gait Training Assisted by Multichannel Functional Electrical Stimulation in Early Stroke Rehabilitation: A Pilot Randomized Controlled Trial.

Background. Many stroke survivors suffer from leg muscle paresis, resulting in asymmetrical gait patterns, negatively affecting balance control and energy cost. Interventions targeting asymmetry early after stroke may enhance recovery of walking. Objective. To determine the feasibility and preliminary efficacy of up to 10 weeks of gait training assisted by multichannel functional electrical stimulation (MFES gait training) applied to the peroneal nerve and knee flexor or extensor muscle on the recovery of gait symmetry and walking capacity in patients starting in the subacute phase after stroke. Methods. Forty inpatient participants (≤31 days after stroke) were randomized to MFES gait training (experimental group) or conventional gait training (control group). Gait training was delivered in 30-minute sessions each workday. Feasibility was determined by adherence (≥75% sessions) and satisfaction with gait training (score ≥7 out of 10). Primary outcome for efficacy was step length symmetry. Secondary outcomes included other spatiotemporal gait parameters and walking capacity (Functional Gait Assessment and 10-Meter Walk Test). Linear mixed models estimated treatment effect postintervention and at 3-month follow-up. Results. Thirty-seven participants completed the study protocol (19 experimental group participants). Feasibility was confirmed by good adherence (90% of the participants) and participant satisfaction (median score 8). Both groups improved on all outcomes over time. No significant group differences in recovery were found for any outcome. Conclusions. MFES gait training is feasible early after stroke, but MFES efficacy for improving step length symmetry, other spatiotemporal gait parameters, or walking capacity could not be demonstrated. Trial Registration. Netherlands Trial Register (NTR4762).

Surplus value of implanted peroneal functional electrical stimulation over ankle-foot orthosis for gait adaptability in people with foot drop after stroke.

BACKGROUND: Implanted peroneal functional electrical stimulation (FES) is an effective alternative treatment to ankle-foot orthosis (AFO) in people with drop foot after stroke. With FES no constraints on ankle mobility are imposed which might particularly be exploited in challenging walking environments that require adaptations of the gait pattern to environmental disturbances. RESEARCH QUESTION: Is gait adaptability, by means of the capacity to avoid sudden obstacles while walking on a treadmill, superior with implanted FES compared to AFO in people with drop foot after stroke? METHODS: A 4-channel peroneal nerve stimulator (ActiGait®) was implanted in 22 persons with stroke (>6 months) who regularly used an AFO. Gait adaptability was tested with an obstacle avoidance task on an instrumented treadmill up to 26 weeks (n = 10) or 52 weeks (n = 12) after FES-system activation. At assessments, 30 trials, in which obstacles were suddenly dropped onto the treadmill in front of the paretic leg, were recorded with each device (FES / AFO). Trials were grouped by available response times (ART) and success rates were calculated. The effect of device, ART and follow up time on success rates was tested using generalized estimated equations. Nonparametric correlations were calculated to associate changes in success rates with clinimetrics. RESULTS: Success rates of obstacle avoidance were higher when participants used their FES system compared to AFO (Δ4.7%, p = 0.03), which effect was largest for longest ARTs (Δ15%, p = 0.03). Participants with greater motor impairment of the paretic leg showed greater benefit from FES (rs=-0.49, p = 0.04). SIGNIFICANCE: FES has been found equally effective as AFO in improving walking speed of people with drop foot after stroke. We now present superior walking performance in a complex walking environment for implanted peroneal FES compared to AFO. These findings underline the importance of using gait assessments that require interplay with the environment, besides assessment of stationary walking, in community ambulators.

Kinematic and kinetic benefits of implantable peroneal nerve stimulation in people with post-stroke drop foot using an ankle-foot orthosis.

BACKGROUND: Contralesional 'drop foot' after stroke is usually treated with an ankle-foot orthosis (AFO). However, AFOs may hamper ankle motion during stance. Peroneal functional electrical stimulation (FES) is an alternative treatment that provides active dorsiflexion and allows normal ankle motion. Despite this theoretical advantage of FES, the kinematic and kinetic differences between AFO and FES have been scarcely investigated. OBJECTIVE: To test whether walking with implanted FES leads to improvements in stance stability, propulsion, and swing initiation compared to AFO. METHODS: A 4-channel peroneal nerve stimulator (ActiGait ®) was implanted in 22 chronic patients after stroke. Instrumented gait analyses were performed during comfortable walking up to 26 weeks (n = 10) or 52 weeks (n = 12) after FES-system activation. Kinematics of knee and ankle (stance and swing phase) and kinetics (stance phase) of gait were determined, besides spatiotemporal parameters. Finally, we determined whether differences between devices regarding late stance kine(ma)tics correlated with those regarding the swing phase. RESULTS: In mid-stance, knee stability improved as the peak knee extension velocity was lower with FES (ß = 18.1°/s, p = 0.007), while peak ankle plantarflexion velocity (ß = -29.2°/s, p = 0.006) and peak ankle plantarflexion power (ß = -0.2 W/kg, p = 0.018) were higher with FES compared to AFO. With FES, the ground reaction force (GRF) vector at peak ankle power (i.e., 'propulsion') was oriented more anteriorly (ß = -1.1°, p = 0.001). Similarly, the horizontal GRF (ß = -0.8% body mass, p = 0.003) and gait speed (ß = 0.03 m/s, p = 0.015) were higher. An increase in peak ankle plantarflexion velocity and a more forward oriented GRF angle during late stance were moderately associated with an increase in hip flexion velocity during initial swing (rs = 0.502, p = 0.029 and rs = 0.504, p = 0.028, respectively). CONCLUSIONS: This study substantiates the evidence that implantable peroneal FES as a treatment for post-stroke drop foot may be superior over AFO in terms of knee stability, ankle plantarflexion power, and propulsion.

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial.

BACKGROUND: Many stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation (MFES)-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients. METHODS: In a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up. DISCUSSION: This study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial. TRIAL REGISTRATION: This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).

Effects of implantable peroneal nerve stimulation on gait quality, energy expenditure, participation and user satisfaction in patients with post-stroke drop foot using an ankle-foot orthosis.

PURPOSE: To investigate whether an implantable functional electrical stimulation (FES) system of the common peroneal nerve (ActiGait®) improves relevant aspects of gait in chronic stroke patients with a drop foot typically using an ankle-foot orthosis (AFO). METHODS: Ten community-dwelling patients participated, of whom eight patients could be analysed. Gait quality (kinematic, kinetic, and spatiotemporal characteristics) during a 10-meter comfortable walk test, normalised net energy expenditure during a 6-minute walk test, participation (physical activity and stroke impact) and user satisfaction were tested before implantation and at various moments after FES-system activation up to 26 weeks. RESULTS: Walking with FES yielded increased maximum paretic ankle plantarflexion (FES: -0.12; AFO: -4.79°, p <  0.01), higher paretic peak ankle power (FES: 1.46; AFO: 0.98 W/kg, p <  0.05) and better step length symmetry (FES: 14.90; AFO: 21.45% , p <  0.05). User satisfaction was higher for FES, but was unrelated to objective gait improvements. Energy expenditure and participation did not change. CONCLUSION: Implantable FES improved the use of residual ankle plantarflexion motion, ankle power of the paretic leg and step length symmetry compared to using an AFO, however, not resulting in decreased energy expenditure or improved participation. User satisfaction was highest with FES, but this was not related to the observed gait improvements.

Feasibility and effectiveness of pre-operative inspiratory muscle training in patients undergoing oesophagectomy: a pilot study.

BACKGROUND: Patients undergoing oesophageal surgery have a high risk for post-operative complications including pulmonary infections. Recently, physical therapy has shifted from the post-operative to the pre-operative phase to diminish post-operative complications and to shorten hospital stay. The purpose of this pilot study was to investigate the feasibility and initial effectiveness of pre-operative inspiratory muscle training (IMT) on the incidence of pneumonia in patients undergoing oesophagectomy. METHODS: A pragmatic non-randomized controlled trial was conducted among all patients who underwent an oesophagectomy between January 2009 and February 2010. Patients in the intervention group received IMT prior to surgery. Feasibility was assessed on the basis of the occurrence of adverse effects during testing or training and patient satisfaction. Initial effectiveness on respiratory function was evaluated by maximal inspiratory pressure (MIP) and endurance, the incidence of post-operative pneumonia and length of hospital stay. RESULTS: Eighty-three patients were included, of which 44 received pre-operative IMT. No adverse effects were observed. IMT was well tolerated and appreciated. In the intervention group, the median MIP and endurance improved significantly after IMT by 32% and 41%, respectively (p < 0.001). The incidence of post-operative pneumonia and the length of hospital stay were comparable for the intervention and the conventional care groups (pneumonia, 25% vs. 23% [p = 0.84]; hospitalization, 13.5 vs. 12 days [p = 0.08]). CONCLUSIONS: Pre-operative IMT is feasible in patients with oesophageal carcinoma and significantly improves respiratory muscle function. This, however, did not result in a reduction of post-operative pneumonia in patients undergoing oesophagectomy.

Immediate effect of a wrist and thumb brace on bimanual activities in children with hemiplegic cerebral palsy.

AIM: The aim of this study was to determine the immediate effect of wearing a wrist and thumb brace on the performance of bimanual activities in children with spastic hemiplegic cerebral palsy. METHOD: In a pre- and post-test cohort study of 25 children (age range 4-11y; mean age 8y 4mo [SD 2y 2mo]; 16 males, 9 females) with spastic hemiplegic cerebral palsy with a Zancolli classification hand score of I, IIA, or IIB (mild and moderate hand dysfunction; children with a Zancolli classification of III - severe hand dysfunction - were excluded from this study), performance of bimanual activities was evaluated with the Assisting Hand Assessment (AHA) on three occasions: one assessment with a static wrist and thumb brace placed on the affected hand and two other assessments without a brace. The differences between AHA scores obtained at the three assessments were evaluated using the repeated measures analysis of variance. RESULTS: Performance of bimanual activities while wearing the brace improved significantly compared to performance without the brace (p<0.001). With the brace, the mean AHA score increased by 3.2 (95% confidence interval 2.1-4.3) from 59.1 to 62.3. The scores of the two assessments without the brace did not differ significantly. INTERPRETATION: In children with spastic hemiplegic cerebral palsy, bracing of the wrist and thumb immediately improves spontaneous use of the affected upper limb in bimanual activities, possibly because bracing permits a more functional hand position.