Cerebrovascular AccidentNCT01769326
Influence of Timing on Motor Learning
A study testing Conventional hand exercise, MusicGlove and Conventional Arm Exercise in people with Cerebrovascular Accident, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Conventional hand exercise, MusicGlove and Conventional Arm Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Conventional hand exercise, MusicGlove, Conventional Arm Exercise, Resonating Arm Exerciser
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional hand exerciseOther
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
MusicGloveDevice
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
Conventional Arm ExerciseOther
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
Resonating Arm ExerciserDevice
Also called RAE
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 group | Role | What they receive |
|---|---|---|
| MusicGlove Group | Experimental | 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 Receives: Device: MusicGlove |
| Control Group for Music Glove | Active comparator | 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. Receives: Other: Conventional hand exercise |
| Resonating Arm Exerciser (RAE) | Experimental | 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 Receives: Device: Resonating Arm Exerciser |
| Control Group for RAE | Active comparator | 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. Receives: Other: Conventional Arm Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor and Strength Outcome Measure Using Box and Block Test
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.
Measured: From baseline to 1 month post therapy
Motor and Strength Outcome Measure Using Fugl-Meyer Score
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.
Measured: From baseline to 1 month post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Steven C. Cramer, MD, University of California, Irvine
- Investigators
- Steven Cramer, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769326
- Sponsor's protocol ID
- HS# 2008-6432
- Other IDs
- R43HD074331-01
- Status last verified
- Jun 2017
- First submitted
- 16 Nov 2012
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27532880Zondervan 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.
PubMed 25273359
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Timing on Motor Learning
- ClinicalTrials.gov ID
- NCT01769326
- Acronym / sponsor ID
- HS# 2008-6432
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MusicGlove Group | Experimental | Device: MusicGloveSubject 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 |
| Control Group for Music Glove | Active comparator | Other: Conventional hand exerciseSubject 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. |
| Resonating Arm Exerciser (RAE) | Experimental | Device: Resonating Arm ExerciserSubject 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 |
| Control Group for RAE | Active comparator | Other: Conventional Arm ExerciseSubject 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional hand exerciseConventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers | Other | Control Group for Music Glove |
| MusicGloveThe MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips. | Device | MusicGlove Group |
| Conventional Arm ExerciseConventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises | Other | Control Group for RAE |
| Resonating Arm ExerciserAlso: RAEThe RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm. | Device | Resonating Arm Exerciser (RAE) |
Primary outcome
Motor and Strength Outcome Measure Using Box and Block Test
Time frame: 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.
Motor and Strength Outcome Measure Using Fugl-Meyer Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27532880Zondervan 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.
- Derived from this study: PubMed 25273359Zondervan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Cramer, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional hand exercise, MusicGlove and Conventional Arm Exercise in people with Cerebrovascular Accident, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor and Strength Outcome Measure Using Box and Block Test (time frame: From baseline to 1 month post therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769326, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.