Cerebrovascular Accident
Conditions
Keywords
Stroke
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.
Interventions
OTHERConventional hand exercise
Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
DEVICEMusicGlove
The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
OTHERConventional Arm Exercise
Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
DEVICEResonating 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame |
|---|---|
| Range of Motion of Shoulder Joint | 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips. | 9 |
| 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.
Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers | 8 |
| 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
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. | 8 |
| 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.
Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises | 8 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | got a job | 0 | 1 | 0 | 0 |
| Overall Study | Got sick and could not complete study | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Overall Study | unrelated injry | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | MusicGlove Group | Total | Control Group for RAE | Resonating Arm Exerciser (RAE) | Control Group for Music Glove |
|---|---|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 54 years | 61 years | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 29 Participants | 7 Participants | 7 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 2 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 19 Participants | 4 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 9 participants | 33 participants | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 7 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 12 | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 0 / 9 | 0 / 8 |
Outcome results
Primary
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.
Time frame: From baseline to 1 month post therapy
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MusicGlove Group | Motor and Strength Outcome Measure Using Box and Block Test | 2.3 blocks | Standard Deviation 6.2 |
| Control Group for Music Glove | Motor and Strength Outcome Measure Using Box and Block Test | 4.3 blocks | Standard Deviation 5 |
Primary
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.
Time frame: From baseline to 1 month post therapy
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MusicGlove Group | Motor and Strength Outcome Measure Using Fugl-Meyer Score | 2.88 units on a scale | Standard Deviation 4.68 |
| Control Group for Music Glove | Motor and Strength Outcome Measure Using Fugl-Meyer Score | 1.31 units on a scale | Standard Deviation 2.59 |
Other Pre-specified
Range of Motion of Shoulder Joint
Time frame: 1 month