StrokeCITNCT03578536
Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
A study testing Recovery Rapids in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Stroke
- What is being tested?
- Recovery Rapids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Jun 2021
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran between 18 and 88 years of age
- Inpatient at the Minneapolis VAHCS
- Willing and able to give Informed Consent or meets criteria for surrogate consent
- Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist
- Lives within vicinity of the Minneapolis VA
Who cannot join
- Complete loss of arm function
- No contact address or telephone
- Active substance use disorder or major uncontrolled psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas.
This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.
Read the detailed description
Research Question
The two questions to be answered by this study are: 1) To what extent does game-based CI therapy (with the Transfer Package) increase use of the more affected upper extremity from inpatient rehabilitation through subacute follow-up.
- What is the clinical effectiveness of distributed gaming CI therapy for improving motor function of the more affected upper extremity at 3 months post-discharge.
Background
Constraint-Induced (CI) Movement therapy is arguably the best treatment paradigm to pilot throughout the continuum of care because it is established as the most empirically-supported intervention in subacute and chronic stroke and is more effective than standard care in acute stroke when lower duration/intensity protocols are utilized. CI therapy has strong evidence of increased effectiveness relative to standard care in the only positive definitively-powered upper extremity trial. A limitation of the acute CI therapy literature is that most studies omitted the most essential component of CI therapy: The Transfer Package of behavioral techniques that promotes carry-over of training to daily activities. In absence of the Transfer Package, everyday use of the weaker arm does not substantially improve and structural brain plasticity and quality of life gains are not realized. Early studies also show that any treatment advantage of CI therapy acutely is not maintained in follow-up, suggesting that maintenance therapy post-discharge is likely essential for altering the recovery trajectory.
Clinical Significance
This work will have a positive impact on the field of rehabilitation because it offers a solution to the main barriers of delivering distributed empirically-based treatment within an inpatient rehabilitation setting. By providing a paradigm for delivering distributed upper extremity practice, the product of this work has the potential to improve post-stroke health outcomes, lower-cost, and maintain the continuity of treatment from inpatient rehabilitation to community care.
Methods
The project will involve participatory action research methods to identify potential barriers to implementation of this new intervention within the VA and to refine the treatment approach to meet the needs of an inpatient population. A focus group will involve at least 3 patients who are currently on the inpatient rehabilitation unit (or recently discharged), their families, and occupational therapy/physical therapy (OT/PT)/recreational therapy staff. This meeting will serve to finalize the treatment protocol for this study. Areas that will be addressed will include the "dosing" schedule for the game-based intervention and needed adaptations to the CI therapy Transfer Package techniques (described below) to promote maximal carry-over from trained activities to everyday use of the weaker upper extremity. Any needed modifications to the technology platform (e.g. data storage) will also be made to comply with the VA's regulatory policies regarding adoption of new technology.
Up to 24 stroke survivors with upper extremity hemiparesis will be enrolled. Participants have the option of taking the gaming system home after discharge.
Gaming CI Therapy (Approximate Schedule)
- 30 total inpatient hours OT/PT:
- One 30-minute session to teach game play
- 4.5 hours devoted to Transfer Package
- Remainder time spent in usual care activities
- 14 hours independent game play while inpatient
- 18 hours independent game play following discharge (30 min, 3 times weekly) over and above standard care (will be documented as covariate)
- Optional use of smart watch with biofeedback
This study will be conducted at the Minneapolis Veterans Affairs Medical Center (MVAMC). The MVAMC is home to the Stroke Specialty Program (SSP), a Commission on Accreditation of Rehabilitation Facilities (CARF) accredited program. The SSP tailors rehabilitation for survivors of any stroke mechanism (hemorrhagic, occlusive, etc.) affecting any part of the brain. Services can be adapted for survivors with cognitive challenges. The SSP has averaged 41 admissions in the past three years, though 2017 has projected admissions over 50. Retrospective chart review demonstrates the primary diagnosis resulting from stroke to be hemiplegia in approximately half of the admissions. Most patients (85%) are older than 60 years, predominantly Caucasian (85%) or African-American (10%) and male (98%).
Study participants will be patients enrolled in the MVAMC Stroke Specialty Program. Prospective participants will be screened by study staff. A retrospective chart review will be conducted to review outcomes of patients who underwent stroke rehabilitation at the Minneapolis VA but did not receive the study intervention. These subjects will serve as a retrospective control.
- Conditions
- Stroke
- Being tested
- Recovery Rapids
- Keywords
- Stroke, Therapy, Occupational, Hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery RapidsDevice
This project utilizes a new gaming system technology called Recovery Rapids. The game is custom-made by Games That Move You, LLC and runs on an XBOX platform with motion input via a Kinect system.
| Study group | Role | What they receive |
|---|---|---|
| CIT with Recovery Rapids | Experimental | This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. Study participants will only be able to play the game using the impaired limb.
A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Patients will also receive automated reminders to use the impaired arm throughout the day. Twelve (12) Veterans will be recruited annually from the inpatient Stroke Specialty Program. Six (6) patients will be assigned to the Treatment group and receive the intervention. The remaining six (6) will receive the current standard of care. Outcome measures will include motor function tests that evaluate upper extremity function. Receives: Device: Recovery Rapids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The ARAT is a 19-item observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip). ARAT scores range from 0-57 points, with 57 points indicating no upper extremity impairment, and 0 points indicating no upper extremity movement.
Measured: The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2
Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)
The Motor Activity Log (MAL) is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress. The Quality of Movement (QOM) subscale has participants rate themselves on how well they perform various activities of daily living with their more affected arm on a 0-5 scale. Scores are averaged across items and range from 0-5, with higher scores indicating the participant's ability to use their affected arm just as well as before their stroke.
Measured: Performed at Day 0 (enrollment) and at discharge (at 6 weeks post-enrollment for subject 1 and 4 weeks post-enrollment for subject 2)
Secondary outcomes (1)
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) is a time-limited method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements.
Measured: The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start30 Sep 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group: Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrew H Hansen, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578536
- Sponsor's protocol ID
- B2726-P
- Other IDs
- RX-002726-01A1
- Acronym
- CIT
- Status last verified
- Apr 2023
- First submitted
- 4 Jun 2018
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing of the IPD. Only a de-identified data set will be available upon request from the PI.
Publications
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
PubMed 11387578Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.
PubMed 27620374
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
- ClinicalTrials.gov ID
- NCT03578536
- Acronym / sponsor ID
- CIT / B2726-P
- Conditions
- Stroke
- Keywords
- Stroke, Therapy, Occupational, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas.
This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.
Detailed description
Research Question
The two questions to be answered by this study are: 1) To what extent does game-based CI therapy (with the Transfer Package) increase use of the more affected upper extremity from inpatient rehabilitation through subacute follow-up.
- What is the clinical effectiveness of distributed gaming CI therapy for improving motor function of the more affected upper extremity at 3 months post-discharge.
Background
Constraint-Induced (CI) Movement therapy is arguably the best treatment paradigm to pilot throughout the continuum of care because it is established as the most empirically-supported intervention in subacute and chronic stroke and is more effective than standard care in acute stroke when lower duration/intensity protocols are utilized. CI therapy has strong evidence of increased effectiveness relative to standard care in the only positive definitively-powered upper extremity trial. A limitation of the acute CI therapy literature is that most studies omitted the most essential component of CI therapy: The Transfer Package of behavioral techniques that promotes carry-over of training to daily activities. In absence of the Transfer Package, everyday use of the weaker arm does not substantially improve and structural brain plasticity and quality of life gains are not realized. Early studies also show that any treatment advantage of CI therapy acutely is not maintained in follow-up, suggesting that maintenance therapy post-discharge is likely essential for altering the recovery trajectory.
Clinical Significance
This work will have a positive impact on the field of rehabilitation because it offers a solution to the main barriers of delivering distributed empirically-based treatment within an inpatient rehabilitation setting. By providing a paradigm for delivering distributed upper extremity practice, the product of this work has the potential to improve post-stroke health outcomes, lower-cost, and maintain the continuity of treatment from inpatient rehabilitation to community care.
Methods
The project will involve participatory action research methods to identify potential barriers to implementation of this new intervention within the VA and to refine the treatment approach to meet the needs of an inpatient population. A focus group will involve at least 3 patients who are currently on the inpatient rehabilitation unit (or recently discharged), their families, and occupational therapy/physical therapy (OT/PT)/recreational therapy staff. This meeting will serve to finalize the treatment protocol for this study. Areas that will be addressed will include the "dosing" schedule for the game-based intervention and needed adaptations to the CI therapy Transfer Package techniques (described below) to promote maximal carry-over from trained activities to everyday use of the weaker upper extremity. Any needed modifications to the technology platform (e.g. data storage) will also be made to comply with the VA's regulatory policies regarding adoption of new technology.
Up to 24 stroke survivors with upper extremity hemiparesis will be enrolled. Participants have the option of taking the gaming system home after discharge.
Gaming CI Therapy (Approximate Schedule)
- 30 total inpatient hours OT/PT:
- One 30-minute session to teach game play
- 4.5 hours devoted to Transfer Package
- Remainder time spent in usual care activities
- 14 hours independent game play while inpatient
- 18 hours independent game play following discharge (30 min, 3 times weekly) over and above standard care (will be documented as covariate)
- Optional use of smart watch with biofeedback
This study will be conducted at the Minneapolis Veterans Affairs Medical Center (MVAMC). The MVAMC is home to the Stroke Specialty Program (SSP), a Commission on Accreditation of Rehabilitation Facilities (CARF) accredited program. The SSP tailors rehabilitation for survivors of any stroke mechanism (hemorrhagic, occlusive, etc.) affecting any part of the brain. Services can be adapted for survivors with cognitive challenges. The SSP has averaged 41 admissions in the past three years, though 2017 has projected admissions over 50. Retrospective chart review demonstrates the primary diagnosis resulting from stroke to be hemiplegia in approximately half of the admissions. Most patients (85%) are older than 60 years, predominantly Caucasian (85%) or African-American (10%) and male (98%).
Study participants will be patients enrolled in the MVAMC Stroke Specialty Program. Prospective participants will be screened by study staff. A retrospective chart review will be conducted to review outcomes of patients who underwent stroke rehabilitation at the Minneapolis VA but did not receive the study intervention. These subjects will serve as a retrospective control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group: Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| CIT with Recovery Rapids | Experimental | Device: Recovery RapidsThis project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. Study participants will only be able to play the game using the impaired limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Patients will also receive automated reminders to use the impaired arm throughout the day. Twelve (12) Veterans will be recruited annually from the inpatient Stroke Specialty Program. Six (6) patients will be assigned to the Treatment group and receive the intervention. The remaining six (6) will receive the current standard of care. Outcome measures will include motor function tests that evaluate upper extremity function. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran between 18 and 88 years of age
- Inpatient at the Minneapolis VAHCS
- Willing and able to give Informed Consent or meets criteria for surrogate consent
- Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist
- Lives within vicinity of the Minneapolis VA
Key exclusion criteria (3 listed)
- Complete loss of arm function
- No contact address or telephone
- Active substance use disorder or major uncontrolled psychiatric disorder
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 |
|---|---|---|
| Recovery RapidsThis project utilizes a new gaming system technology called Recovery Rapids. The game is custom-made by Games That Move You, LLC and runs on an XBOX platform with motion input via a Kinect system. | Device | CIT with Recovery Rapids |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2
The ARAT is a 19-item observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip). ARAT scores range from 0-57 points, with 57 points indicating no upper extremity impairment, and 0 points indicating no upper extremity movement.
Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)
Time frame: Performed at Day 0 (enrollment) and at discharge (at 6 weeks post-enrollment for subject 1 and 4 weeks post-enrollment for subject 2)
The Motor Activity Log (MAL) is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress. The Quality of Movement (QOM) subscale has participants rate themselves on how well they perform various activities of daily living with their more affected arm on a 0-5 scale. Scores are averaged across items and range from 0-5, with higher scores indicating the participant's ability to use their affected arm just as well as before their stroke.
1 secondary outcome
Wolf Motor Function Test (WMFT)
Time frame: The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11387578Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
- Background: PubMed 27620374Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.
- Individual participant dataSharing planned: No. There will be no sharing of the IPD. Only a de-identified data set will be available upon request from the PI.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Andrew H Hansen, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Rapids in people with Stroke, run by VA Office of Research and Development 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 3 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 16 Jan 2024. 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 16 Jan 2024). 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?
Action Research Arm Test (ARAT) (time frame: The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2). 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 NCT03578536, 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 16 Jan 2024.