Stroke Clinical Trial
Official title:
Soft Robotic Hand System for Stroke Rehabilitation
NCT number | NCT03286309 |
Other study ID # | 2017.396-T |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 12, 2018 |
Est. completion date | July 1, 2022 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Biomedical Engineering, The Chinese University of Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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 |
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