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

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 comparative clinical effectiveness of distributed gaming CI therapy versus
standard care 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 first 3 months of 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 half-day focus
group "retreat" 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.

Beginning month 4, 24 stroke survivors with upper extremity hemiparesis and at least 30
degrees of shoulder flexion, 30 degrees of shoulder abduction, and 30 degrees elbow flexion
will be assigned using order of presentation into game-based CI therapy or usual care.

Comparison of Gaming CI Therapy and Standard Care Interventions

Gaming CI Therapy

Standard Care

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. Continuous use of smart watch with biofeedback

1) 30 total inpatient hours OT/PT: active assisted range of motion exercise, activities of
daily living (ADL) practice, high-repetition task-specific training, mirror therapy,
strengthening, functional electrical stimulation (FES), and/or ArmeoSpring.

2) Standard care post-discharge (will be documented as covariate)

3) Continuous use of smart watch to track activity

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 the PI as part of regularly administered
assistive technology (AT) assessments. Patients meeting study criteria who choose to
participate will be assigned to Game-based CI therapy or usual care control groups,
respectively in the order of presentation. Twelve subjects will be recruited each year for a
sample of 24. Assuming 20% attrition by 3-month follow-up, the investigators anticipate a
sample of 20.

Inclusion Criteria:

- Inpatient enrolled in the Stroke Specialty Program at Minneapolis VA

- Willing and able to give Informed Consent

- Upper extremity hemiparesis with:

- 30 degrees of shoulder flexion

- 30 degrees of shoulder abduction

- 30 degrees of elbow flexion

Exclusion Criteria:

- Inadequate cognitive and/or language function to consent or to participate in research
activities

- Complete loss of arm function

- No contact address or telephone number

- Active substance use disorder or

- Major uncontrolled psychiatric disorder