Functional Viability Duck Duck Punch (DDPSBIR)
|Rehabilitation Recovery of Function Stroke||Device: Duck Duck Punch Play Behavioral: Commercially Available Game Play|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Stroke survivors will either play a custom designed computer game for stroke rehabilitation called Duck Duck Punch or an off the shelf computer game with their weaker arm 3 times per week for 6 weeks. Evaluations will determine whether or not one computer game improved arm movement more than the other.Masking: Outcomes Assessor
Blinded raters perform scoring of all assessmentsPrimary Purpose: Treatment
|Official Title:||Establishing the Functional Viability and Dose-response of Duck, Duck Punch: A Stroke Rehabilitation Computer Game|
- Fugl-Meyer Upper Extremity Assessment (FMA-UE) [ Time Frame: Change from baseline at post 6 weeks of intervention ]33 item measure of upper extremity (UE) impairment
- Wolf Motor Function Test (WMFT) [ Time Frame: Change from baseline at post 6 weeks of intervention ]15 item measure of UE functional ability
- Kinematic Variable; Shoulder flexion-elbow extension interjoint coordination [ Time Frame: Change from baseline at post 6 weeks of intervention ]Shoulder flexion-elbow extension interjoint coordination
- Kinematic Variable; Trunk displacement [ Time Frame: Change from baseline at post 6 weeks of intervention ]Displacement of the upper trunk marker during reaching task
|Actual Study Start Date:||January 10, 2017|
|Estimated Study Completion Date:||October 31, 2018|
|Estimated Primary Completion Date:||October 31, 2018 (Final data collection date for primary outcome measure)|
Experimental: Duck Duck Punch
Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.
Device: Duck Duck Punch Play
The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors.
Active Comparator: Commercially Available Game
Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.
Behavioral: Commercially Available Game Play
The behavioral intervention will include playing a hands-free video game available off-the-shelf.
Stroke is a problem nationally, but especially in the southeastern USA, a region known as the "stroke belt" where stroke incidence is high and age of stroke onset is low. The vast majority, >75%, of stroke survivors experience paresis of one arm/hand that does not resolve acutely. Long-term arm movement impairment restricts independence with self-care and vocational activities, increases caregiver burden and reduces quality of life. Although rehabilitation improves outcomes, systematic financial pressures increasingly limit its duration. Unfortunately, this is happening at a time when strong evidence is emerging that traditional therapy programs do not provide adequate amounts of movement practice needed for motor recovery. Thus, there is a need for innovative technology to augment traditional stroke rehabilitation programs in a way that can provide the necessary movement practice within the constraints of current rehabilitation practice.
To meet this need, the Principal Investigators developed a prototype Kinect-based post-stroke rehabilitation game called Duck Duck Punch (DDP). While maintaining the appeal of a game, DDP has a therapeutic focus because its unique design elicits an arm motor recovery process consistent with evidence-based stroke rehabilitation principles. The player moves his/her physical arm to control an avatar arm to reach and "punch" virtual ducks. Custom features allow tailoring of game difficulty to match a player's impairment level so that the player seeks to accomplish optimally challenging movement goals. By design, the avatar does not respond to atypical arm motions, which encourages the player to trial and error a variety of motions until implicitly learning the more normal strategy. Thus, unlike most commercially available "off the shelf" games, success requires "therapist approved" healthy arm motions. Success motivates continued game play for extended practice of healthy motions. Therapists can integrate DDP into in-clinic or in-home therapies for additional quasi-supervised movement practice and receive a performance report that quantifies and monitors progress toward recovery goals. Further development of this report will enable its integration into a billable rehabilitation program.
The Investigators licensed DDP and formed a company, Recovr, which has received investment funding for initial start-up and market research. Of note, DDP has also received FDA 510(k) Clearance to "support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities." In a funded NIH/NIGMS pilot project, the investigators established the technical merit and feasibility of DDP as a tool to augment inpatient, outpatient and home-based stroke rehabilitation by increasing therapist- and patient-directed movement practice opportunities. Very promising results motivated the current project that seeks to test the functional viability of DDP and determine its commercial potential.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03053492
|Contact: Michelle L Woodbury, PhDemail@example.com|
|Contact: Scott Hutchison, MSfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Scott Hutchison, MS 843-792-2712 email@example.com|
|Contact: Michelle Woodbury, PhD 843-792-1671 firstname.lastname@example.org|
|Principal Investigator: Austen Hayes, PhD|
|Principal Investigator: Michelle L Woodbury, PhD|
|Principal Investigator:||Michelle L Woodbury, PhD||Medical University of South Carolina|