A Community-Based, Bionic Leg Rehabilitation Program for Patients with Chronic Stroke: Clinical Trial Protocol

Area of Science:

• Rehabilitation Medicine
• Biomedical Engineering
• Neurology

Background:

• Stroke survivors often experience persistent mobility deficits, impacting their quality of life.
• Current physiotherapy may not fully address the unmet needs in chronic stroke recovery.
• Robotic-assisted devices, like bionic legs, offer potential adjuncts to traditional rehabilitation.

Purpose of the Study:

• To investigate the impact of a community-based bionic leg training program on stroke survivors.
• To assess biomechanical, cardiovascular, and functional outcomes following robotic-assisted rehabilitation.
• To evaluate the clinical significance and feasibility of home-based bionic leg use.

Main Methods:

• A dual-center, randomized, parallel group clinical trial design.
• Participants randomized into three groups: physiotherapy + bionic leg, physiotherapy only, or usual care.
• 10-week intervention with daily home-based bionic leg activity, followed by assessments at 10 weeks, 3, and 12 months.

Main Results:

• The study aims to assess improvements in gait, postural sway, vascular health (blood pressure, arterial stiffness), and functional status (6-minute walk test).
• Clinical significance of the bionic leg intervention will be evaluated for each outcome variable.
• Potential for meaningful impact on patients' quality of life is a key focus.

Conclusions:

• Community-based bionic leg training may enhance recovery for chronic stroke survivors.
• Robotic devices integrated into home-based rehabilitation could be cost-effective and beneficial.
• This approach holds promise for improving long-term functional status and quality of life post-stroke.