Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study

Official title

Effictiveness of Multichannel Functionnal Electrical Motor and Sensorimotor Stimulation for Subchronic Stroke Gait Rehabilitation

Overview

The goal of this interventional study is to evaluate the effect of multichannel functionnal electrical stimulation for subchronic stroke gait rehabilitation. The main questions it aims to answer are: * Does this new therapy help improve walking speed? * Evaluate other aspects of therapeutic effectiveness such as different aspects of walking endurance, mobility, postural instability and autonomy. * Evaluate physiological aspects of autonomous gait such as spasticity, muscle strength and motor and sensorimotor recovery. * Evaluate the acceptability of this new therapy and its effect on quality of life.

Interventions

• Device Multichannel functionnal electrical stimulation
  The participants completed 24 gait rehabilitation sessions over the course of 8 to 12 weeks. Each session lasted between 30 minutes and 1 hour. A minimum of 2 days seperated two consecutive sessions. The number of sessions was used for standardization of the protocol instead of duration of treatment. Four evaluations were completed throughout the protocol. Baseline evaluation(V1) was completed between 2 and 7 days before the first rehabilitation session. Intermediate evaluation(V2) was complete

Primary outcome measures

• Change in walking speed at intermediate evaluation [Time frame: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)]
• Change in walking speed at post-treatment evaluation [Time frame: At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)]
• Change in walking speed at follow-up evaluation [Time frame: At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)]

Secondary outcome measures (12)

• Change in walking endurance at intermediate evaluation [Time frame: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)]
• Change in walking endurance at post-treatment evaluation [Time frame: At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)]
• Change in walking endurance at follow-up evaluation [Time frame: At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)]
• Change in muscle spasticity at intermediate evaluation [Time frame: At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline)]
• Change in muscle spasticity at post-treatment evaluation [Time frame: At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline)]
• Change in muscle spasticity at follow-up evaluation [Time frame: At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline)]
• Change in muscle strength at intermediate evaluation [Time frame: At baseline evaluation and intermediate evaluation (4 to 6 weeks after baseline)]
• Change in muscle strength at post-treatment evaluation [Time frame: At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline)]
• Change in muscle strength at follow-up evaluation [Time frame: At baseline evaluation and follow-up evaluation (16 to 20 weeks after baseline)]
• Change in ambulation capacity at intermediate evaluation [Time frame: At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline)]
• Change in ambulation capacity at post-treatment evaluation [Time frame: At baseline evaluation and post-treatment evaluation(8 to 12 weeks after baseline)]
• Change in ambulation capacity at follow-up evaluation [Time frame: At baseline evaluation and follow-up evaluation(16 to 20 weeks after baseline)]

Eligibility criteria

Inclusion criteria

• First ischemic stroke or first hemorrhagic supratentorial stroke
• Stroke must be unique
• Stoke event in the last 12 months but no sooner than 6 months (post subchronic stroke phase)
• Able to walk with the support of one person and one or multiple walking aids (new functionnal ambulatory classification equal to 1, 2 or 3)
• Able to tolerate and respond to electrical stimulation(Muscle strength grading level 3 while having the quadriceps stimulated)
• Willing to delay anti-spastic treatments like botulinic toxins and motor blockers until the end of the rehabilitation period included in the protocol

Exclusion criteria

• Multiple strokes
• Does not respond sufficiently to electrical stimulation
• Contraindication to electrical stimulation
• Comprehension, psychiatric or cognitive problems that could hamper the protocol
• Bilateral stroke or subtentorial stroke
• Able to walk without the support of one person (new functionnal ambulatory clssification equal to 4 or more)
• Needing help from more than one person to walk (new functionnal ambulatory classification equal to 0)
• Moderate spasticity in one or more lower body muscle groups (Modified Ashworth Scale Score >= 2)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07211672 · RD-25-0532

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗