Influence of Timing on Motor Learning

Cerebrovascular Accident Clinical Trial

Official title:

Influence of Timing on Motor Learning

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

• Cerebrovascular Accident
• Stroke

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