â??A Hand in Need - A self-driven hand rehabilitation device
Not Applicable
Completed
- Conditions
- Health Condition 1: G540- Brachial plexus disordersHealth Condition 2: M65-M67- Disorders of synovium and tendonHealth Condition 3: G50-G59- Nerve, nerve root and plexus disordersHealth Condition 4: M678- Other specified disorders of synovium and tendon
- Registration Number
- CTRI/2018/09/015800
- Lead Sponsor
- Biotechnology Industry Research Assistance Council BIRAC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patient with Neuromuscular deficit, or any hand injury that requires mobilization of fingers.
Exclusion Criteria
1. Severe Spasticity in the affected hand
2. Acute inflammation or unstable skin conditions
3. Open wound on hand /arm.
4. Any Serious Psychiatric or Medical Condition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Validate the device and get user feedback. Usability Testing is conducted to get feedback on Comfort, Reliability and Repeatability of the Device. <br/ ><br>These are done based on following Outcome measures: <br/ ><br>1. Feasibility: <br/ ><br>a. Based on Number of patients completing the program. <br/ ><br>b. Level of difficulty for managing the device. <br/ ><br>By VAS (visual analogue scale). ( 0 - extremely simple - 10 - extremely difficult) <br/ ><br>Timepoint: Once a Week for 4 Weeks
- Secondary Outcome Measures
Name Time Method Qualitative assessment by doctor/ therapist (Based on Feedback by the Patient) <br/ ><br>a. Condition of skin (redness in contacted area of the glove) Yes / No <br/ ><br>b. Difficulty in understanding instructions. Yes / No <br/ ><br>c. Comfort of the Glove ( 0 - extremely comfortable - 10 - extremely difficult) <br/ ><br>d. Weight of the Overall Device ( 0 - extremely light - 10 - extremely heavy) <br/ ><br>Timepoint: Once a Week for 4 Weeks