NCT03808428

Brief Summary

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis to facilitate gait training of person after stroke with drop foot.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

December 20, 2018

Last Update Submit

January 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Lower Extremity (FMA-LE)

    3-month follow-up

Secondary Outcomes (5)

  • Functional Ambulation Classification (FAC)

    3-month follow-up

  • Modified Ashworth Scale (MAS)

    3-month follow-up

  • Berg Balance Scale (BBS)

    3-month follow-up

  • Timed 10-Meter Walk Test (10MWT)

    3-month follow-up

  • 6 Minute Walk Test (6MWT)

    3-month follow-up

Study Arms (1)

Ankle Group

EXPERIMENTAL

Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.

Device: Ankle Group

Interventions

Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.

Ankle Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have the ability to walk on the ground independently or with one personal assistance with or without walking aids
  • able to understand simple commends

You may not qualify if:

  • have other neurological, neuromuscular, and orthopedic diseases
  • uncontrolled cardiovascular or respiratory disorders
  • moderate to severe contractures in the lower extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 17, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations