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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04934787

Enrollment

Registered

2021-06-22

Start date

2021-07-01

Completion date

2027-12-31

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Stroke, Foot Drop, Foot Inversion Deformity

Keywords

Robot, Stroke, Lower limb

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.

Interventions

DEVICEENMS-BSF assisted gait training

1. ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking. 2. Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session. 3. 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

CONTACTXiaoling Hu, PhD

xiaoling.hu@polyu.edu.hk34003206

CONTACTCherrie Mok

cherrie.mok@polyu.edu.hk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026