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Functional Viability Duck Duck Punch

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03053492
Acronym
DDPSBIR
Enrollment
66
Registered
2017-02-15
Start date
2017-01-10
Completion date
2019-02-08
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery of Function, Rehabilitation, Stroke

Keywords

Video Games

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.

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.

Interventions

DEVICEDuck Duck Punch Play

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

BEHAVIORALCommercially Available Game Play

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinded raters perform scoring of all assessments

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Extremity Assessment (FMA-UE)Change from baseline at post 6 weeks of intervention33 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)

Secondary

MeasureTime frameDescription
Wolf Motor Function Test (WMFT)Change from baseline at post 6 weeks of interventionThe 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.
Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint CoordinationChange from baseline at post 6 weeks of interventionShoulder 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).
Kinematic Variable; Trunk DisplacementChange from baseline at post 6 weeks of interventionDisplacement of the upper trunk marker during reaching task

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors.
33
Commercially Available Game
Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf.
33
Total66

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event11
Overall StudyWithdrawal by Subject75

Baseline characteristics

CharacteristicDuck Duck PunchCommercially Available GameTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants9 Participants21 Participants
Age, Categorical
Between 18 and 65 years
21 Participants24 Participants45 Participants
Age, Continuous63.45 years
STANDARD_DEVIATION 12.33
58.24 years
STANDARD_DEVIATION 10.91
60.85 years
STANDARD_DEVIATION 11.85
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants32 Participants65 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
13 Participants17 Participants30 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
20 Participants13 Participants33 Participants
Region of Enrollment
United States
33 participants33 participants66 participants
Sex: Female, Male
Female
16 Participants15 Participants31 Participants
Sex: Female, Male
Male
17 Participants18 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 33
other
Total, other adverse events
1 / 331 / 33
serious
Total, serious adverse events
0 / 330 / 33

Outcome results

Primary

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)

Time frame: Change from baseline at post 6 weeks of intervention

ArmMeasureValue (MEAN)Dispersion
Duck Duck PunchFugl-Meyer Upper Extremity Assessment (FMA-UE)0.13 Units on a scaleStandard Deviation 0.03
Commercially Available GameFugl-Meyer Upper Extremity Assessment (FMA-UE)0.12 Units on a scaleStandard Deviation 0.04
Secondary

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).

Time frame: Change from baseline at post 6 weeks of intervention

ArmMeasureValue (MEAN)Dispersion
Duck Duck PunchKinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination-0.02 Units on a scaleStandard Deviation 0.2
Commercially Available GameKinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination-0.01 Units on a scaleStandard Deviation 0.18
Secondary

Kinematic Variable; Trunk Displacement

Displacement of the upper trunk marker during reaching task

Time frame: Change from baseline at post 6 weeks of intervention

ArmMeasureValue (MEAN)Dispersion
Duck Duck PunchKinematic Variable; Trunk Displacement13.89 mmStandard Deviation 38.84
Commercially Available GameKinematic Variable; Trunk Displacement-6.02 mmStandard Deviation 23.73
Secondary

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.

Time frame: Change from baseline at post 6 weeks of intervention

ArmMeasureValue (MEAN)Dispersion
Duck Duck PunchWolf Motor Function Test (WMFT)0.12 Time (seconds)Standard Deviation 0.1
Commercially Available GameWolf Motor Function Test (WMFT)-0.5 Time (seconds)Standard Deviation 0.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026