Spinal Cord InjuriesNCT02473614
Efficacy Study of the Music Glove Patients With Spinal Cord Injuries
A study testing Music Glove and Conventional Hand Exercise Program in people with Spinal Cord Injuries, run by University of California, Irvine at 1 site in United States.
Trial summary
Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. All participants will be randomized into two groups: AB and BA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Music Glove and Conventional Hand Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 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
- History of spinal cord injury affecting the arm and hand functions, at least 6 months prior to enrollment
- Upper extremity weakness as measured on a standard clinical scale
- No active major psychiatric problems, or neurological/orthopedic problems affecting the training upper extremity
- No active major neurological disease other than the spinal cord injury
- Absence of pain in the affected upper extremity
Who cannot join
- Severe tone at the affected upper extremity as measured on a standard clinical scale
- Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
- Difficulty in understanding or complying with instructions given by the experimenter
- Inability to perform the experimental task that will be studied
- Increased pain with movement of the training upper extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises
Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with minimum of 3 hours of exercise time per week. Participants will receive the other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and 3-week post-second intervention follow up visits.
- Conditions
- Spinal Cord Injuries
- Being tested
- Music Glove, Conventional Hand Exercise Program
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music GloveDevice
Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimum of 3 hours per week.
Conventional Hand Exercise ProgramOther
Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimum of 3 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Music Glove | Experimental | Music Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved. Receives: Device: Music Glove |
| Conventional Hand Exercise Program | Active comparator | Conventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital. Receives: Other: Conventional Hand Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test
We compared the change of Box and Blocks Test (BBT) scores from baseline evaluation to the end of 3-week of therapy, and from 1-month post first intervention to the end of the second 3-week therapy. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate better outcomes.
Measured: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
Secondary outcomes (1)
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
We used the GRASSP to capture information on upper limb impairment from the SCI population through three domains: Strength, Sensibility, and Prehension. We focused on the Prehension section of the test. The prehension ability domain consists of three different tasks 1) Cylindrical Grasp, 2) Lateral Key Pinch, \& 3) Tip to Tip Pinch and one can score 0-4 for each task for a total of 12 points for this section. The prehension performance domain consists of 1) pour water from a bottle, 2) open jars, 3) pick up \& turn a key, 4) transfer 9 pegs board to board, 5) pick up 4 coins \& place in the slot, 6) screw 4 nuts onto bolts and one can score 0-5 for each task for a total of 30 points. The score for each domain of the prehension test is totaled for each of the upper extremities with ranges from 0 to 42. The higher scores indicate better functional outcomes.
Measured: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 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 (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli Sharp, University of California, Irvine
- Investigators
- Kelli Sharp, DPT, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473614
- Sponsor's protocol ID
- 2R44HD074331-02 [2008-6432]
- Other IDs
- 2R44HD074331-02
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2015
- Last updated
- 7 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sanders Q, Chan V, Augsburger R, Cramer SC, Reinkensmeyer DJ, Sharp K. Feasibility of home hand rehabilitation using musicglove after chronic spinal cord injury. Spinal Cord Ser Cases. 2022 Nov 9;8(1):86. doi: 10.1038/s41394-022-00552-4.
PubMed 36347833
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises
- ClinicalTrials.gov ID
- NCT02473614
- Acronym / sponsor ID
- 2R44HD074331-02 [2008-6432]
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with minimum of 3 hours of exercise time per week. Participants will receive the other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and 3-week post-second intervention follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Glove | Experimental | Device: Music GloveMusic Glove is a glove with sensors attached to the tips of all 5 fingers. The glove is connected to a software musical program like guitar hero. Participants will follow the rhythm or musical notes of the songs and move their fingers accordingly. Participants are reinforced with biofeedback that includes visual and auditory cues when the correct sequences are achieved. |
| Conventional Hand Exercise Program | Active comparator | Other: Conventional Hand Exercise ProgramConventional Hand Exercise Program includes range of motion exercises, strengthening exercises, coordinating exercises of the hand and fingers. This exercise program is designed by an occupational therapist and is a general exercise program that a stroke patient will receive when he/she is being discharged from the hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of spinal cord injury affecting the arm and hand functions, at least 6 months prior to enrollment
- Upper extremity weakness as measured on a standard clinical scale
- No active major psychiatric problems, or neurological/orthopedic problems affecting the training upper extremity
- No active major neurological disease other than the spinal cord injury
- Absence of pain in the affected upper extremity
Key exclusion criteria (5 listed)
- Severe tone at the affected upper extremity as measured on a standard clinical scale
- Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
- Difficulty in understanding or complying with instructions given by the experimenter
- Inability to perform the experimental task that will be studied
- Increased pain with movement of the training upper extremity
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 |
|---|---|---|
| Music GloveParticipants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimum of 3 hours per week. | Device | Music Glove |
| Conventional Hand Exercise ProgramParticipants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimum of 3 hours per week. | Other | Conventional Hand Exercise Program |
Primary outcome
Box and Blocks Test
Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
We compared the change of Box and Blocks Test (BBT) scores from baseline evaluation to the end of 3-week of therapy, and from 1-month post first intervention to the end of the second 3-week therapy. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate better outcomes.
1 secondary outcome
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36347833Sanders Q, Chan V, Augsburger R, Cramer SC, Reinkensmeyer DJ, Sharp K. Feasibility of home hand rehabilitation using musicglove after chronic spinal cord injury. Spinal Cord Ser Cases. 2022 Nov 9;8(1):86. doi: 10.1038/s41394-022-00552-4.
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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.
Kelli Sharp, DPT 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 Music Glove and Conventional Hand Exercise Program in people with Spinal Cord Injuries, 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 5 inclusion and 5 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 7 Jun 2021. 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 7 Jun 2021). 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?
Box and Blocks Test (time frame: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.). 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 NCT02473614, which also lists 1 linked publication.
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 7 Jun 2021.