Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

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.
    

Intervention name(s): Recovery Rapids
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: Single Group: Clinical trials with a single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Therapy, Occupational; Hemiplegia