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

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04934787
• Collaborator: Innovation and Technology Commission, Hong Kong (Other), Prince of Wales Hospital, Shatin, Hong Kong (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Stroke; Foot Drop; Foot Inversion Deformity	Device: ENMS-BSF assisted gait training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ENMS-BSF assisted gait training The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.	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.
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.	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.
Sham Comparator: Sham ENMS-BSF assisted gait training The participants will only wear the device without assistance during a 20-session gait rehabilitation.	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.

Outcome Measures

Primary Outcome Measures

1. Change in Fugl-Meyer Assessment [before, one day after, and 3 months after the training]

   To evaluate the voluntary motor function of the lower limb after the interventions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		China

Sponsors and Collaborators

• The Hong Kong Polytechnic University
• Innovation and Technology Commission, Hong Kong
• Prince of Wales Hospital, Shatin, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoling Hu, Assistant Profession, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT04934787
• Other Study ID Numbers: ITS/062/19
• First Posted: Jun 22, 2021
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaoling Hu, Assistant Profession, The Hong Kong Polytechnic University: Robot; Stroke; Lower limb
• Additional relevant MeSH terms: Stroke; Peroneal Neuropathies

Study Results

No Results Posted as of Aug 24, 2022