ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation

Cerebrovascular Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934787
• Other study ID #: ITS/062/19
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Foot Drop
• Peroneal Neuropathies
• Stroke

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