NCT03848624

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. Our research team had developed the "Interactive FES Cycling System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system can integrate both motor power and muscle power in order to facilitate an active rehabilitative exercise.

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 Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.8 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

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

February 19, 2019

Last Update Submit

March 12, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment for Lower-Extremity

    Fugl-Meyer Assessment for Lower-Extremity (FMA-LE), consists of 34-level cumulative scoring system to examine lower-limb functions of hemiplegic stroke patients quantitatively through a set of lower-limb movement tasks in reflex, flexor/extensor synergy, volitional movement, coordination and speed (Fugl-Meyer, et al., 1975). All assessment items are either scoring "full", "partial", or "none" functionality in the affected side, which minimizes ceiling and floor effects. FMA-LE demonstrated high internal consistency and a reliable assessment tool for a group of 140 hemiplegic community dwelling patients (Park \& Choi, 2014).

    Three months after the last training session

Secondary Outcomes (5)

  • 6 Minute Walk Test

    Three months after the last training session

  • Timed 10-meter Walk Test

    Three months after the last training session

  • Berg Balance Scale

    Three months after the last training session

  • Modified Ashworth Scale

    Three months after the last training session

  • Functional Ambulation Category Test

    Three months after the last training session

Study Arms (1)

Cycling Group

EXPERIMENTAL

Intention driven motor-assisted voluntary cycling with electrical stimulation

Device: Cycling Group

Interventions

Cycling GroupDEVICE

Electrical pulses from a stimulator can stimulate the target muscles to generate muscle contraction to support a continuous cycling motion

Cycling Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
  • Significant gait deficit (Functional Ambulatory Category, FAC\<4 \[person cannot walk independently\]).

You may not qualify if:

  • Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
  • Severe hip, knee or ankle contracture that would preclude passive range of motion of the leg (MAS\<3).

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

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+85239438454kytong@cuhk.edu.hk

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

February 19, 2019

First Posted

February 21, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)