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NCT Number: NCT04934787

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

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.

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Key information

Conditions

Cerebrovascular Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Foot Drop Foot Inversion Deformity Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peroneal Neuropathies Stroke Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

Location status: Recruiting

Location contact

Xiaoling Hu, Ph.D.

CONTACT

[email protected]

+852 34003205

Xiaoling Hu, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENMS-BSF assisted gait training

Device
  • 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.

Primary outcomes

  1. Change in Fugl-Meyer Assessment

    Time frame: before, one day after, and 3 months after the training

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cherrie Mok

CONTACT

[email protected]

Xiaoling Hu, PhD

CONTACT

[email protected]

34003206

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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