Clinical trial NCT02882997: An Interactive Computer Game, Called Duck Duck Punch, for Stroke Rehabilitation at Home and in a Rehabilitation Clinic
Official title: A Virtual Environment for Post-Stroke Upper Extremity Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2016-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.

Detailed description: More than 75% of the 800,000 people who annually suffer stroke exhibit persistent arm/hand hemiparesis restricting independence thus burdening caregivers. Arm motor skill can recover if the rehabilitation program provides an adequate "dose" of repetitive movement practice. However, the vast majority of stroke survivors lack the proper practice-dose because the duration of inpatient stroke rehabilitation is limited by cost, or residence in medically underserved rural settings. To meet the pressing need for innovative cost-effective rehabilitation options, the investigators developed, tested and licensed a prototype virtual environment (VE) for post-stroke arm rehabilitation. Its custom built design motivates extended practice of specific arm motor skills known to improve quality of life. Excitingly, practice sessions do not require direct therapist supervision. Published pilot data demonstrated improved real-world arm movement after VE training. These promising initial results led to software upgrades that will now enable installation and testing in the primary markets for this technology; stroke rehabilitation hospitals, and patients' homes. The overall goal for this small pilot study is to test the feasibility of self-directed VE practice in these settings measured by movement repetitions and motor skill improvement. To that end, this project will address the following Specific Aims (1) Determine the number of daily movement repetitions and treatment effect achieved by inpatients in a stroke rehabilitation hospital who self-direct VE practice sessions during non-therapy hours (evenings, weekends) compared to standard evening activities; and (2) Determine the number of daily movement repetitions and treatment effect achieved by in-home stroke survivors who self-direct daily VE practice sessions compared to a group of in-home survivors with a standard self-directed exercise program.

Eligibility criteria: Inclusion Criteria:

* experienced uni-hemispheric ischemic or hemorrhagic stroke
* exhibit voluntarily shoulder flexion (affected UE) ≥20° with simultaneous elbow extension ≥10°. We reason that persons at this motor ability level have enough residual arm activation to engage in VE training
* passive range of motion in affected shoulder and elbow and within 20 degrees of normal values

Additional inclusion criteria for community dwelling stroke survivors

* live at home
* no current rehabilitation therapy
* live within a 60 minute drive of the university

Additional inclusion criteria for inpatient stroke patients

* medically stable
* expected to remain in the hospital for the next 7 days
* able to sit in a chair for 60 minutes without difficulty

Exclusion Criteria:

* lesion in brainstem or cerebellum
* presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)
* pain in the paretic arm that would interfere with movement
* unable to understand and follow 3-step directions
* orthopedic condition or impaired corrected vision that would interfere with reaching.

Primary outcomes:
measure: Paretic arm use
timeFrame: 1 year
Secondary outcomes:
measure: Fugl Meyer Upper Extremity Assessment
timeFrame: up to 7 days
measure: Wolf Motor Function Test
timeFrame: up to 7 days
measure: Stroke Impact Scale - Hand subtest
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michelle L Woodbury, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woodbury ML, Anderson K, Finetto C, Fortune A, Dellenbach B, Grattan E, Hutchison S. Matching Task Difficulty to Patient Ability During Task Practice Improves Upper Extremity Motor Skill After Stroke: A Proof-of-Concept Study. Arch Phys Med Rehabil. 2016 Nov;97(11):1863-1871. doi: 10.1016/j.apmr.2016.03.022. Epub 2016 Apr 23.