Soft Robotic Hand System for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Soft Robotic Hand System for Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286309
• Other study ID #: 2017.396-T
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Chinese University of Hong Kong
• Contact: Raymond Kai-yu Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);

2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;

3. able to sit up for 45 minutes (with or without assistance).

Exclusion criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication;

2. any additional medical or psychological condition affecting their ability to comply with the study protocol;

3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• soft robot hand system
subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper limb Fugl Meyer Assessment		3-month follow up
Secondary	Action Research Arm Test		3-month follow up
Secondary	Modified Ashworth Scale	Scale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension	3-month follow up
Secondary	Box and Block Test		3-month follow up
Secondary	Max Voluntary Grip Force		3-month follow up