Influence of Timing on Motor Learning

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01769326
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 51
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Other: Conventional hand exercise; Device: MusicGlove; Other: Conventional Arm Exercise; Device: Resonating Arm Exerciser	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Influence of Timing on Motor Learning
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MusicGlove Group Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program	Device: MusicGlove; The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
Active Comparator: Control Group for Music Glove Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.	Other: Conventional hand exercise; Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
Experimental: Resonating Arm Exerciser (RAE) Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program	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.; Other Names: RAE
Active Comparator: Control Group for RAE Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.	Other: Conventional Arm Exercise; Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

Outcome Measures

Primary Outcome Measures

1. Motor and Strength Outcome Measure Using Box and Block Test [From baseline to 1 month post therapy]

   The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.

2. Motor and Strength Outcome Measure Using Fugl-Meyer Score [From baseline to 1 month post therapy]

   The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.

Other Outcome Measures

1. Range of Motion of Shoulder Joint [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Steven Cramer, MD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven C. Cramer, MD, Professor of Neurology, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT01769326
• Other Study ID Numbers: HS# 2008-6432; R43HD074331-01
• First Posted: Jan 16, 2013
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Steven C. Cramer, MD, Professor of Neurology, University of California, Irvine: Stroke
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	MusicGlove Group	Control Group for Music Glove	Resonating Arm Exerciser (RAE)	Control Group for RAE
Arm/Group Description	Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.	Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers	Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program 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.	Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
Period Title: Overall Study
STARTED	11	12	9	8
COMPLETED	9	8	8	8
NOT COMPLETED	2	4	1	0

Baseline Characteristics

Arm/Group Title	MusicGlove Group	Control Group for Music Glove	Resonating Arm Exerciser (RAE)	Control Group for RAE	Total
Arm/Group Description	Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.	Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers	Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program 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.	Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises	Total of all reporting groups
Overall Participants	9	8	8	8	33
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	60	59	61	54	60
Sex: Female, Male (Count of Participants)
Female	4 44.4%	3 37.5%	2 25%	1 12.5%	10 30.3%
Male	5 55.6%	5 62.5%	6 75%	7 87.5%	23 69.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 11.1%	1 12.5%	1 12.5%	1 12.5%	4 12.1%
Not Hispanic or Latino	8 88.9%	7 87.5%	7 87.5%	7 87.5%	29 87.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	2 22.2%	2 25%	2 25%	2 25%	8 24.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	1 12.5%	0 0%	1 12.5%	2 6.1%
White	6 66.7%	4 50%	5 62.5%	4 50%	19 57.6%
More than one race	1 11.1%	1 12.5%	1 12.5%	1 12.5%	4 12.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	8 100%	8 100%	8 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Motor and Strength Outcome Measure Using Box and Block Test
Description	The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.
Time Frame	From baseline to 1 month post therapy

Outcome Measure Data

Analysis Population Description

Number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline. Please note that box and block test was the primary outcome measure for the Music Glove part of the study.

Arm/Group Title	MusicGlove Group	Control Group for Music Glove
Arm/Group Description	Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.	Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
Measure Participants	9	8
Mean (Standard Deviation) [blocks]	2.3 (6.2)	4.3 (5.0)

2. Primary Outcome

Title	Motor and Strength Outcome Measure Using Fugl-Meyer Score
Description	The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.
Time Frame	From baseline to 1 month post therapy

Outcome Measure Data

Analysis Population Description

Fugl-Meyer score at one month post therapy minus Fugl-Meyer score at baseline on a 66 point scale. Please note that Fugl-Meyer UE motor score is the primary outcome measure for RAE part of the study.

Arm/Group Title	Resonating Arm Exerciser (RAE)	Control Group for RAE
Arm/Group Description	Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program 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.	Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
Measure Participants	8	8
Mean (Standard Deviation) [units on a scale]	2.88 (4.68)	1.31 (2.59)

3. Other Pre-specified Outcome

Title	Range of Motion of Shoulder Joint
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	MusicGlove Group		Control Group for Music Glove		Resonating Arm Exerciser (RAE)		Control Group for RAE
Arm/Group Description	Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.		Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers		Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program 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.		Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program. Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
All Cause Mortality
	MusicGlove Group		Control Group for Music Glove		Resonating Arm Exerciser (RAE)		Control Group for RAE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MusicGlove Group		Control Group for Music Glove		Resonating Arm Exerciser (RAE)		Control Group for RAE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/12 (0%)		0/9 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	MusicGlove Group		Control Group for Music Glove		Resonating Arm Exerciser (RAE)		Control Group for RAE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/12 (0%)		0/9 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.