AzTrials
AzTrials

RehabilitationDDPSBIRNCT03053492

Functional Viability Duck Duck Punch

A study testing Duck Duck Punch Play and Commercially Available Game Play in people with Rehabilitation and Recovery of Function, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Rehabilitation, Recovery of Function, Stroke
What is being tested?
Duck Duck Punch Play and Commercially Available Game Play
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
10 Jan 2017to 8 Feb 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 21-90 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Establishing the Functional Viability and Dose-response of Duck, Duck Punch: A Stroke Rehabilitation Computer Game

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.

Read the detailed description

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.

Being tested
Duck Duck Punch Play, Commercially Available Game Play
Keywords
Video Games
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duck Duck Punch PlayDevice

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

  • Commercially Available Game PlayBehavioural

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

Study groups in NCT03053492
Study groupRoleWhat they receive
Duck Duck PunchExperimentalSubjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks.
Receives: Device: Duck Duck Punch Play
Commercially Available GameActive comparatorSubjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks.
Receives: Behavioral: Commercially Available Game Play

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Change from baseline at post 6 weeks of intervention

Secondary outcomes (3)
  1. Wolf Motor Function Test (WMFT)

    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 a better outcome. A large average item performance time (near 120 seconds) indicates less functional ability and thus a poorer outcome.

    Measured: Change from baseline at post 6 weeks of intervention

  2. Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination

    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).

    Measured: Change from baseline at post 6 weeks of intervention

  3. Kinematic Variable; Trunk Displacement

    Displacement of the upper trunk marker during reaching task

    Measured: Change from baseline at post 6 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2017
  2. Study start10 Jan 2017
  3. Primary completion8 Feb 2019
  4. Study completion8 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053492
Sponsor's protocol ID
Pro00059924
Other IDs
1R44NS097061-01A1
Acronym
DDPSBIR
Status last verified
Jul 2020
First submitted
8 Feb 2017
Last updated
3 Aug 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: At the conclusion of the study, de-identified data will be available to other researchers and may be obtained by emailing the PI

Questions about this trial

What is this clinical trial studying?

A study testing Duck Duck Punch Play and Commercially Available Game Play in people with Rehabilitation and Recovery of Function, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Upper Extremity Assessment (FMA-UE) (time frame: Change from baseline at post 6 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in