Trial Outcomes & Findings for Functional Viability Duck Duck Punch (NCT NCT03053492)
NCT ID: NCT03053492
Last Updated: 2020-08-03
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Change from baseline at post 6 weeks of intervention
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
Baseline Characteristics
Functional Viability Duck Duck Punch
Baseline characteristics by cohort
| Measure |
Duck Duck Punch
n=33 Participants
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.
|
Commercially Available Game
n=33 Participants
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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Continuous
|
63.45 years
STANDARD_DEVIATION 12.33 • n=99 Participants
|
58.24 years
STANDARD_DEVIATION 10.91 • n=107 Participants
|
60.85 years
STANDARD_DEVIATION 11.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
66 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Duck Duck Punch
n=33 Participants
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.
|
Commercially Available Game
n=33 Participants
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.
|
|---|---|---|
|
Fugl-Meyer Upper Extremity Assessment (FMA-UE)
|
0.13 Units on a scale
Standard Deviation 0.03
|
0.12 Units on a scale
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Duck Duck Punch
n=33 Participants
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.
|
Commercially Available Game
n=33 Participants
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.
|
|---|---|---|
|
Wolf Motor Function Test (WMFT)
|
0.12 Time (seconds)
Standard Deviation 0.10
|
-0.5 Time (seconds)
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Change 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).
Outcome measures
| Measure |
Duck Duck Punch
n=33 Participants
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.
|
Commercially Available Game
n=33 Participants
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.
|
|---|---|---|
|
Kinematic Variable; Shoulder Flexion-elbow Extension Interjoint Coordination
|
-0.02 Units on a scale
Standard Deviation 0.20
|
-0.01 Units on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Change from baseline at post 6 weeks of interventionDisplacement of the upper trunk marker during reaching task
Outcome measures
| Measure |
Duck Duck Punch
n=33 Participants
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.
|
Commercially Available Game
n=33 Participants
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.
|
|---|---|---|
|
Kinematic Variable; Trunk Displacement
|
13.89 mm
Standard Deviation 38.84
|
-6.02 mm
Standard Deviation 23.73
|
Adverse Events
Duck Duck Punch
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Commercially Available Game
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duck Duck Punch
n=33 participants at risk
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.
|
Commercially Available Game
n=33 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall Unrelated to Study
|
0.00%
0/33 • Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 months.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 months.
|
|
Respiratory, thoracic and mediastinal disorders
Visit to ER Unrelated to Study
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 months.
|
0.00%
0/33 • Adverse event data were collected throughout the duration of the study a total of 1 year, and 11 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place