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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04934787
Other study ID # ITS/062/19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date December 2024

Study information

Verified date January 2024
Source The Hong Kong Polytechnic University
Contact Xiaoling Hu, PhD
Phone 34003206
Email xiaoling.hu@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) >3. - Receiving other lower limb rehabilitative interventions at the same time

Study Design


Intervention

Device:
ENMS-BSF assisted gait training
ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane.

Locations

Country Name City State
China The Hong Kong Polytechnic University Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Innovation and Technology Commission, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fugl-Meyer Assessment To evaluate the voluntary motor function of the lower limb after the interventions before, one day after, and 3 months after the training
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