CUHK Jockey Club Tech-based Stroke Rehabilitation Programme - ARR

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638218
• Other study ID #: 2019.377
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: January 2022

Study information

• Verified date: November 2020
• Source: Chinese University of Hong Kong
• Contact: Raymond Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	The Hong Kong Jockey Club Charities Trust

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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