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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Cerebrovascular Stroke; Foot Inversion Deformity; Foot Drop

Treatments: Device: ENMS-BSF assisted gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT04934787

ITS/062/19

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

ENMS-BSF assisted gait training

Experimental group

Description:

The participants will receive the full assistance of the ENMS-BSF during a 20-session gait rehabilitation.

Treatment:

Device: ENMS-BSF assisted gait training

Partial ENMS-BSF assisted gait training

Active Comparator group

Description:

The participants will receive a partial assistance of the ENMS-BSF during a 20-session gait rehabilitation.

Treatment:

Device: ENMS-BSF assisted gait training

Sham ENMS-BSF assisted gait training

Sham Comparator group

Description:

The participants will only wear the device without assistance during a 20-session gait rehabilitation.

Treatment:

Device: ENMS-BSF assisted gait training