Functional Viability Duck Duck Punch

NCT03053492 | Completed Results FDA Device

• 2 other identifiers: Pro000599241R44NS097061-01A1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study has 2 parts: In one part of this study, people with stroke 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. In the second part of the study, people with stroke, caregivers of people with stroke and stroke rehabilitation therapists will meet in several focus groups to design a useful and informative Duck Duck Punch performance report.

Conditions

Rehabilitation; Recovery of Function; Stroke

Keywords

Video Games

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Assessment (FMA-UE)

  33 item measure of upper extremity (UE) motor control impairment. Total scores were analyzed from 0/66 (indicating a severe impairment, no motor control) to 66/66 (indicating a mild impairment, with near normal motor control)

  Change from baseline at post 6 weeks of intervention

Secondary Outcomes (3)

• Wolf Motor Function Test (WMFT)

  Change from baseline at post 6 weeks of intervention

• Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination

  Change from baseline at post 6 weeks of intervention

• Kinematic Variable; Trunk Displacement

  Change from baseline at post 6 weeks of intervention

Study Arms (2)

Duck Duck Punch

EXPERIMENTAL

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

Commercially Available Game

ACTIVE COMPARATOR

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

Interventions

Duck Duck Punch Play DEVICE

The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors.

Duck Duck Punch

Commercially Available Game Play BEHAVIORAL

The behavioral intervention will include playing a hands-free video game available off-the-shelf.

Commercially Available Game

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• experienced unilateral hemispheric ischemic or hemorrhagic stroke at least 3 months but no more than 7 years prior
• exhibit voluntarily shoulder flexion of the affected arm ≥30° with simultaneous elbow extension ≥20°. The investigators reason that persons at this motor ability level have residual arm activation and enough ability to engage in treatment-related reaching movements elicited by the computer games
• baseline FMA-UE score of at least 19 points but no more than 52 points (out of 60 points) based on previously published research by this study's investigators in which categories were defined based on post-stroke UE motor impairment
• passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values
• years of age
• a caregiver or friend who is willing to assist with the set up and operation of the computer game throughout the 6 week intervention.

You may not qualify if:

• lesion in brainstem or cerebellum because lesions in these locations my interfere with the visual-perceptual and cognitive skills needed for motor re-learning as is expected to occur as a result of the intervention
• presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)
• pain in the affected arm that interferes with reaching movements
• significant cognitive impairment, defined as Montreal Cognitive Assessment score \< 22
• orthopedic condition or impaired corrected vision that alters the kinematics of reaching
• unable to travel to the UE Motor Function Laboratory in Charleston, South Carolina 4 times (pre-, mid- post- and retention testing).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michelle Woodbury
• Organization: Medical University of South Carolina

woodbuml@musc.edu

843-792-1671

Study Officials

• Michelle L Woodbury, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded raters perform scoring of all assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 15, 2017
• Study Start: January 10, 2017
• Primary Completion: February 8, 2019
• Study Completion: February 8, 2019
• Last Updated: August 3, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)