Personalized Post-Stroke Gait Rehabilitation Interventions

Boston University Charles River Campus

Status: Completed

Conditions: Stroke

Treatments: Device: Propulsion neuroprosthesis; Device: Soft robotic exosuit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07212608

5715-FEX

830019 (Other Grant/Funding Number)

U54EB015408 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to different walking rehabilitation interventions that augment paretic limb propulsion (e.g., soft robotic exosuits or electrical stimulation neuroprostheses). The results of this work could improve post-stroke gait recovery outcomes by informing clinical decision-making to better match patients with rehabilitation devices tailored to their specific gait characteristics.

Full description

Stroke is a leading cause of long-term disability that results in slow, asymmetrical, and inefficient walking. Personalized treatments matching patients to the treatments with which they are most likely to respond are not typical but are necessary to maximize recovery.

Post-stroke hemiparesis is commonly associated with reduced paretic limb propulsion that leads to slower, less efficient walking patterns. Our team has developed and tested two rehabilitation technologies targeting paretic propulsion: i) a soft robotic exosuit that uses cables to mechanically assist ankle dorsiflexion and plantarflexion during walking; ii) a neuroprosthesis that uses functional electrical stimulation (FES) to activate the dorsiflexor and plantarflexor muscles during walking. Both technologies aim to safely improve walking speed and paretic propulsion. The objective of this study is to evaluate if certain post-stroke patient subsets, identified from baseline clinical, biomechanical, and neuromuscular characteristics, preferentially respond to propulsion rehabilitation using soft robotic exosuits or electrical stimulation neuroprostheses.

Twenty participants with chronic (>6 months) stroke will complete one baseline gait evaluation in the laboratory and two gait training sessions: i) an exosuit day and ii) a neuroprosthesis day. Each visit will include walking with/without the respective technology.

The primary aim of this study is to identify predictors of a therapeutic response (i.e., improvement in walking speed) to determine whether certain patient subsets preferentially respond to the exosuit or the neuroprosthesis. We will evaluate baseline clinical, biomechanical, and neuromuscular abilities as potential predictors of a response. We hypothesize that a subset of individuals will respond preferentially to each intervention and that baseline measures of gait function will predict responders to each intervention.

A secondary aim of this study is to determine the rehabilitation mechanism underlying improved walking speed after walking with the propulsion exosuit and the neuroprosthesis. Improvements in walking speed can be achieved through recovery (e.g., increased propulsion symmetry) or compensation (e.g., increased nonparetic propulsion). We will independently evaluate the underlying biomechanical changes contributing to improvements in speed and metabolic cost. We hypothesize that both the exosuit and neuroprosthesis will promote improved speed via recovery of paretic propulsion.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of a stroke event occurring at least 6 months ago
• Observable gait deficits
• Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
• Passive ankle dorsiflexion range of motion to neutral with the knee extended
• Ability to follow a 3-step command
• Resting heart rate between 40-100 bpm
• Resting blood pressure between 90/60 and 170/90 mmHg
• NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
• HIPAA authorization to allow communication with healthcare provider
• Medical clearance by a physician

Exclusion criteria

• Severe aphasia or inability to communicate with investigators
• Neglect or hemianopia
• Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
• Serious comorbidities that may interfere with ability to participate in the research (e.g., musculoskeletal, cardiovascular, pulmonary)
• Pacemakers or similar electrical implants that could be affected by the FES
• Pressure ulcers or skin wounds located near human-device interface sites
• More than 2 unexplained falls in the previous month
• Actively receiving physical therapy for walking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Exosuit Training

Experimental group

Description:

A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with a soft robotic exosuit powered on and off. Shorter overground and treadmill evaluations without the exosuit will be completed immediately before and after the training.

Treatment:

Device: Soft robotic exosuit

Neuroprosthesis Training

Active Comparator group

Description:

A single 30-minute training of goal-directed overground walking practice at a moderately fast speed with the propulsion neuroprosthesis powered on and off. Shorter overground and treadmill evaluations without neurostimulation will be completed immediately before and after the training.

Treatment:

Device: Propulsion neuroprosthesis