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CUHK Jockey Club HOPE 4 Care Programme - FES Bike

CUHK Jockey Club HOPE 4 Care Programme - Interactive FES Cycling System

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848624
Enrollment
120
Registered
2019-02-21
Start date
2019-04-01
Completion date
2021-12-31
Last updated
2019-03-14

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

Conditions

Stroke

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.

Interventions

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

Sponsors

The Hong Kong Jockey Club Charities Trust
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 \[person cannot walk independently\]).

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment for Lower-ExtremityThree months after the last training sessionFugl-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).

Secondary

MeasureTime frameDescription
6 Minute Walk TestThree months after the last training sessionSix-Minute Walk Test (SMWT), measures the maximum walking distance covered in fixed duration as a sub-maximal test of endurance and aerobic capacity. The measurement of 6MWT is highly correlated to FAC (Mehrholz, et al., 2007) with good reliability (ICC=0.94-0.96) (Steffen, Hacker & Mollinger, 2002).
Timed 10-meter Walk TestThree months after the last training sessionTimed 10-Meter Walk Test (10mWT), measures comfortable and fast walking speeds in short distance. The ability to increase walking speed above a comfortable pace suggests the capability to adapt to varying environments, such as crossing street, with high reliability (ICC=0.90-0.96) (Flansbjer, et al., 2005). Average walking speed of healthy elderly subjects ranges in 0.6m/s-1.4m/s, and can increase to 21%-56% above the comfortable pace for faster walking speed.
Berg Balance ScaleThree months after the last training sessionBerg Balance Scale (BBS), consists of 56-level measures to examine balance ability and to predict falling risk with high reliability (ICC=0.98) (Steffen, Hacker & Mollinger, 2002). Stroke patients were assessed based on their performance on 14 simple mobility tasks, including transfer, standing, and reaching.
Modified Ashworth ScaleThree months after the last training sessionModified Ashworth Scale (MAS), consists of 4-level scale to examine joint spasticity based on muscle tone and resistance detected during passive stretching with good inter-rater reliability (ICC =0.85) (Bohannon & Smith, 1987).
Functional Ambulation Category TestThree months after the last training sessionFunctional Ambulatory Category (FAC) is a reliable measurement of independent walking ability on level-ground walking and stair ambulation, which is a good prediction of independent community walking post-stroke (Mehrholz, et al., 2007). FAC consists of 6-level scale: patients with FAC=4 requires supervision in level ground walking, FAC=5 requires supervision only when walking on non-level surface such as stairs.

Countries

Hong Kong

Contacts

Primary ContactRaymond Tong, PhD
kytong@cuhk.edu.hk+85239438454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026