CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR

CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - Augmented Reality (AR) Rehabilitation Training System

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Rehabilitation Training System

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Reality; 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.	Device: Rehabilitation Training System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Three months after the last training session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Three months after the last training session
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.	Three months after the last training session
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	Three months after the last training session
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).	Three months after the last training session
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).	Three months after the last training session
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).	Three months after the last training session
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).	Three months after the last training session

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The Hong Kong Jockey Club Charities Trust
• Investigators: Principal Investigator: Raymond Tong, PhD, Department of Biomedical Engineering, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2019.377

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No