NCT03053492: DDPSBIR

Functional Viability Duck Duck Punch

Completed NA Results posted Last updated 3 August 2020

What this trial tests

NA trial testing Duck Duck Punch Play in Rehabilitation in 66 participants. Completed in 8 February 2019.

Timeline

10 January 2017

Primary endpoint
8 February 2019

8 February 2019

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	66
Start date	10 January 2017
Primary completion	8 February 2019
Estimated completion	8 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Duck Duck Punch Play
• Commercially Available Game Play

Conditions studied

• Rehabilitation — all drugs for Rehabilitation →
• Recovery of Function — all drugs for Recovery of Function →
• Stroke — all drugs for Stroke →

Sponsor

Medical University of South Carolina

Who can join

Adults 21 to 90, any sex, with Rehabilitation or Recovery of Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fugl-Meyer Upper Extremity Assessment (FMA-UE) Primary · Change from baseline at post 6 weeks of intervention

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)

Group	Value	95% CI
Duck Duck Punch	0.13	± 0.03
Commercially Available Game	0.12	± 0.04

Wolf Motor Function Test (WMFT) Secondary · Change from baseline at post 6 weeks of intervention

The Wolf Motor Function Test contains 15 items, each of which measure upper extremity functional ability by recording the time (seconds) required to accomplish the task. High functional ability is evident in quicker performance times near 0 seconds. Low functional ability is evident in slower performance times near 120 seconds. The assessment is scored by recording the time to perform each of the 15 items (0 seconds to 120 seconds per item), then the average item performance time is calculated. A small average item performance time (near 0 seconds) indicates higher functional ability and thus

Group	Value	95% CI
Duck Duck Punch	0.12	± 0.10
Commercially Available Game	-0.5	± 0.14

Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination Secondary · Change from baseline at post 6 weeks of intervention

Shoulder flexion-elbow extension interjoint coordination. Correlation between the shoulder flexion and elbow extension joint angles during a forward reach movement. Values range from -1 (indicating an abnormal flexor synergy pattern, i.e. higher impairment) to 1 (indicating movement similar to a healthy individual, i.e. lower impairment).

Group	Value	95% CI
Duck Duck Punch	-0.02	± 0.20
Commercially Available Game	-0.01	± 0.18

Kinematic Variable; Trunk Displacement Secondary · Change from baseline at post 6 weeks of intervention

Displacement of the upper trunk marker during reaching task

Group	Value	95% CI
Duck Duck Punch	13.89	± 38.84
Commercially Available Game	-6.02	± 23.73

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Duck Duck Punch

Serious: 0/33 (0%)

Deaths: 0/33

Commercially Available Game

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (2 terms — click to expand)

Reaction	System	Duck Duck Punch	Commercially Available Game
Fall Unrelated to Study	Musculoskeletal and connective tissue disorders	—	—
Visit to ER Unrelated to Study	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT03053492 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development of a Short Form Assessment Combining the Fugl-Meyer Assessment-Upper Extremity and the Wolf Motor Function Test for Evaluating Stroke Recovery.
   Woodbury M, Grattan ES, Li CY. · · 2023 · cited 5× · PMID 37245692 · DOI 10.1016/j.apmr.2023.04.029