Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• At least 6 months after the onset of stroke

• Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21).

• Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.

• Fugl-Meyer Assessment (FMA), total score on the lower limb \<20

• Functional Ambulatory Category (FAC) ≥4

• Berg Balance Scale (BBS) ≥40

Locations
Other Locations
China
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Xiaoling Hu, PhD
xiaoling.hu@polyu.edu.hk
34003206
Backup
Cherrie Mok
cherrie.mok@polyu.edu.hk
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: ENMS-BSF assisted gait training
The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Active_comparator: Partial ENMS-BSF assisted gait training
The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.
Sham_comparator: Sham ENMS-BSF assisted gait training
The participants will only wear the device without assistance during a 20-session gait rehabilitation.
Related Therapeutic Areas
Sponsors
Collaborators: Prince of Wales Hospital, Shatin, Hong Kong, Innovation and Technology Commission, Hong Kong
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov