Clinical trial NCT01769326: Influence of Timing on Motor Learning
Official title: Influence of Timing on Motor Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor and Strength Outcome Measure Using Box and Block Test
timeFrame: From baseline to 1 month post therapy
measure: Motor and Strength Outcome Measure Using Fugl-Meyer Score
timeFrame: From baseline to 1 month post therapy
Secondary outcomes:
Other outcomes:
measure: Range of Motion of Shoulder Joint
timeFrame: 1 month
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Steven Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zondervan DK, Friedman N, Chang E, Zhao X, Augsburger R, Reinkensmeyer DJ, Cramer SC. Home-based hand rehabilitation after chronic stroke: Randomized, controlled single-blind trial comparing the MusicGlove with a conventional exercise program. J Rehabil Res Dev. 2016;53(4):457-72. doi: 10.1682/JRRD.2015.04.0057.
citation: Zondervan DK, Augsburger R, Bodenhoefer B, Friedman N, Reinkensmeyer DJ, Cramer SC. Machine-Based, Self-guided Home Therapy for Individuals With Severe Arm Impairment After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jun;29(5):395-406. doi: 10.1177/1545968314550368. Epub 2014 Oct 1.