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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01769326
Other study ID # HS# 2008-6432
Secondary ID R43HD074331-01
Status Recruiting
Phase N/A
First received November 16, 2012
Last updated October 24, 2016
Start date September 2012
Est. completion date December 2016

Study information

Verified date October 2016
Source University of California, Irvine
Contact Vicky Chan, MS
Phone (949) 824-8423
Email vchan2@uci.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.


Description:

The purpose of this research study is to compare different methods for training hand movement at home after stroke. This study involves research because it will test two experimental devices, the MusicGlove and the Resonating Arm Exerciser (RAE), compared to conventional hand and arm exercises. The MusicGlove is a glove that measures finger movements and allows its user to play a musical computer game using those movements. The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 18 to 80 years of age

- Sustained a single stroke affecting the arm, at least three months prior to enrollment

- Minimal to moderate lost motor control of the arm after stroke

- No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke-affected upper extremity

- No active major neurological disease other than the stroke

- Absence of pain in the stroke-affected upper extremity

Exclusion Criteria:

- Severe tone at the affected upper extremity

- Severe aphasia

- Severe reduced level of consciousness

- Severe sensory/proprioception deficit at the affected upper extremity

- Currently pregnant

- Difficulty in understanding or complying with instructions

- Inability to perform the experimental task that will be studied

- Increased pain with movement of the stroke-affected upper extremity

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Conventional hand exercise
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
Device:
MusicGlove
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
Other:
Conventional Arm Exercise
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
Device:
Resonating Arm Exerciser
The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Locations

Country Name City State
United States University of California, Irvine Irvine California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Range of Motion of Shoulder Joint 10 weeks No
Primary Motor and Strength outcome measure using Box and Block Test 10 weeks No
Secondary Motor and Strength outcome measure using Fugl-Meyer Score 10 weeks No
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