Back to resultsCUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Rehabilitation Training System
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
- Motor impairment in upper-limb, lower-limb, and/or balance;
- No or mild spasticity on the lower-limb or upper-limb (MAS≤2);
- Have sufficient cognition to follow the instructions provided by the rehab system.
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 shoulder or arm contracture/pain;
- Severe knee or hip contracture/pain
- Pregnant women
Sites / Locations
- Department of Biomedical Engineering, The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Augmented Reality
Arm Description
The system provides visual and audio feedback which makes the rehabilitation training process more relaxing, interesting and convenient to guide the patients performing appropriate upper-limb, lower-limb exercises and balance training.
Outcomes
Primary Outcome Measures
Berg Balance Scale
Berg 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
Secondary Outcome Measures
Modified Ashworth Scale
Modified 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 Test
Functional 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.
Timed 10-meter Walk Test
Timed 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
6 Minute Walk Test
Six-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).
Wolf Motor Function Test (WMFT)
The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).
Action Research Arm Test (ARAT)
The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
Fugl-Meyer Assessment
Fugl-Meyer Assessment for Upper-Extremity the maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.
Fugl-Meyer Assessment for Lower-Extremity 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).
Full Information
NCT ID
NCT04638218
First Posted
November 17, 2020
Last Updated
November 17, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust
1. Study Identification
Unique Protocol Identification Number
NCT04638218
Brief Title
CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR
Official Title
CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - Augmented Reality (AR) Rehabilitation Training System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Jockey Club Charities Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 "Augmented Reality (AR) Rehabilitation Training System" that can be used as tools for rehabilitation by individuals who have suffered from a stroke or elderly. The system facilitates an active rehabilitative exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Augmented Reality
Arm Type
Experimental
Arm Description
The system provides visual and audio feedback which makes the rehabilitation training process more relaxing, interesting and convenient to guide the patients performing appropriate upper-limb, lower-limb exercises and balance training.
Intervention Type
Device
Intervention Name(s)
Rehabilitation Training System
Intervention Description
The system can capture useful biomechanical data accurately, such as the location of body centre of mass (COM), the body joint angles, and the body posture. These useful data are stored in a database and can be conveniently accessed by the therapists, which facilitate the follow-up of the patients' therapeutic progress.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Berg 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
Time Frame
Three months after the last training session
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
Modified 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).
Time Frame
Three months after the last training session
Title
Functional Ambulation Category Test
Description
Functional 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.
Time Frame
Three months after the last training session
Title
Timed 10-meter Walk Test
Description
Timed 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
Time Frame
Three months after the last training session
Title
6 Minute Walk Test
Description
Six-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).
Time Frame
Three months after the last training session
Title
Wolf Motor Function Test (WMFT)
Description
The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).
Time Frame
Three months after the last training session
Title
Action Research Arm Test (ARAT)
Description
The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
Time Frame
Three months after the last training session
Title
Fugl-Meyer Assessment
Description
Fugl-Meyer Assessment for Upper-Extremity the maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.
Fugl-Meyer Assessment for Lower-Extremity 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).
Time Frame
Three months after the last training session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Diagnosis of ischemic brain injury or intracerebral haemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
Motor impairment in upper-limb, lower-limb, and/or balance;
No or mild spasticity on the lower-limb or upper-limb (MAS≤2);
Have sufficient cognition to follow the instructions provided by the rehab system.
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 shoulder or arm contracture/pain;
Severe knee or hip contracture/pain
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Tong, PhD
Phone
+852 3943 8454
Email
kytong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
Organizational Affiliation
Department of Biomedical Engineering, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biomedical Engineering, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Tong, PhD
12. IPD Sharing Statement
Learn more about this trial
CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR
We'll reach out to this number within 24 hrs