Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting (CIT)

• ClinicalTrials.gov Identifier: NCT03578536
• Recruitment Status: Completed
• First Posted: July 6, 2018
• Last Update Posted: July 21, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Recovery Rapids	Not Applicable

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.

2) 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)

1. 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
2. 14 hours independent game play while inpatient
3. 18 hours independent game play following discharge (30 min, 3 times weekly) over and above standard care (will be documented as covariate)
4. 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group: Clinical trials with a single arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
• Actual Study Start Date: September 30, 2019
• Actual Primary Completion Date: June 30, 2021
• Actual Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: CIT with Recovery Rapids; 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.	Device: Recovery Rapids; 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.
No Intervention: Standard of Care; As part of standard care, participants will receive a minimum of daily OT, PT and Speech for a total of three hours. Current occupational therapy intervention options for inpatient stroke rehab patients with UE neuromotor impairments include active assisted range of motion exercise, morning bedside ADL sessions, high-repetition task-specific training, mirror therapy, Digi-flex, theraputty, theraband, free weights, weighted therapy bars for strengthening exercises in clinic and use with home exercise programs (HEP). Additional tools used as determined by therapist include FES modalities to assist with upper extremity neuromotor re-education, unweighted reaching tasks via the ArmeoSpring, and functional work task training/strengthening. They also participate in recreation therapy as appropriate.

Outcome Measures

Primary Outcome Measures :

1. Motor Activity Log (MAL) Change [ Time Frame: Performed during hospitalization, from enrollment approximately every 7 days for 3 weeks with the treating occupational therapist (Day 0, 7, 14, 21) ]
   Assessment to measure carry-over into daily life. The Motor Activity Log is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress.
2. Action Research Arm Test (ARAT) [ Time Frame: The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentiall at 3 months post-discharge. ]
   The ARAT is an observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip).

Secondary Outcome Measures :

1. Wolf Motor Function Test (WMFT) Change [ Time Frame: The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentiall at 3 months post-discharge. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 88 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Complete loss of arm function
• No contact address or telephone
• Active substance use disorder or major uncontrolled psychiatric disorder

Contacts and Locations

Locations

United States, Minnesota

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Andrew H Hansen, PhD; Minneapolis VA Health Care System, Minneapolis, MN

More Information

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.

Taub 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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03578536
• Other Study ID Numbers: B2726-P; RX-002726-01A1 ( Other Grant/Funding Number: VA-RR&D-SPIRE )
• First Posted: July 6, 2018
• Last Update Posted: July 21, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There will be no sharing of the IPD. Only a de-identified data set will be available upon request from the PI.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Stroke; Therapy, Occupational; Hemiplegia

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases