Trial Outcomes & Findings for Exercise-primed Upper Extremity Motor Practice in Chronic Stroke (NCT NCT04259424)
NCT ID: NCT04259424
Last Updated: 2023-05-06
Results Overview
The FMA-UE is a 33-item measure of upper extremity impairment; however, the 3 items testing reflex response will not be administered because they do not measure a voluntary movement construct. Each item will be scored on a 3-point rating scale (0=unable, 1=partial 2=near normal performance), item ratings will be summed and reported out of 60 points so that larger numbers indicate greater upper extremity motor ability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Pre and post intervention, approximately 6 weeks
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise-primed Upper Extremity Motor Practice in Chronic Stroke
Baseline characteristics by cohort
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Age, Continuous
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53.6 years
STANDARD_DEVIATION 11.5 • n=99 Participants
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Sex: Female, Male
Female
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4 Participants
n=99 Participants
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Sex: Female, Male
Male
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6 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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10 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=99 Participants
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Race (NIH/OMB)
White
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4 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Pre and post intervention, approximately 6 weeksThe FMA-UE is a 33-item measure of upper extremity impairment; however, the 3 items testing reflex response will not be administered because they do not measure a voluntary movement construct. Each item will be scored on a 3-point rating scale (0=unable, 1=partial 2=near normal performance), item ratings will be summed and reported out of 60 points so that larger numbers indicate greater upper extremity motor ability.
Outcome measures
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Change in Upper Extremity Impairment as Assessed by the Fugl-Meyer Assessment - Upper Extremity
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2.6 units on a scale
Standard Deviation 5.2
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SECONDARY outcome
Timeframe: Pre and post intervention, approximately 6 weeksPopulation: Change in Wolf Motor Function Test - Time
The WMFT is a 15-item measure of UE functional ability. Performance of each item will be timed (seconds) and the average time to perform items will be reported so that lower values indicate greater UE function.
Outcome measures
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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|---|---|
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Change in Upper Extremity as Assessed by the Wolf Motor Function Test
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.1 seconds
Standard Deviation 17.6
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SECONDARY outcome
Timeframe: Pre and post intervention, approximately 6 weeksPopulation: Change in Stroke Impact Scale - Recovery subtest, Change in SIS-hand subtest.
The SIS-hand consists of 5-items regarding difficulty of paretic hand use during everyday tasks during the previous two weeks. Items will be rated on a 5-point scale (5=not difficult, 1=cannot do) and reported as an average item rating. The SIS-recovery subtest is a single-item in which the participant rates his/her perceived post-stroke recovery from 0%-100% recovered.
Outcome measures
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Change in Physical Function and Health-related Quality of Life as Assessed by Stroke Impact Scale
SIS - Recovery
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8.5 units on a scale
Standard Deviation 10.6
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Change in Physical Function and Health-related Quality of Life as Assessed by Stroke Impact Scale
SIS - Hand
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-0.5 units on a scale
Standard Deviation 6.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Pre and post intervention, approximately 6 weeksPopulation: Relative change in Post-PAS MEP amplitude from pre-intervention
Participants' neuroplastic potential will be assessed with a plasticity-inducing paradigm called Paired Associative Stimulation (PAS). Briefly, PAS utilizes a repeated and timed peripheral nerve stimulation combined with transcranial magnetic stimulation (TMS) of the contralateral motor cortex to induce motor cortex plasticity. Prior to- and after PAS, corticomotor excitability (CME) is assessed via motor evoked potentials (MEP) which are obtained by single pulse TMS and electromyography (EMG) of a contralateral peripheral muscle.
Outcome measures
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=7 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Change in Neuroplastic Potential as Assessed by Paired Associative Stimulation
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2.2 percentage of change in MEP amplitude
Standard Deviation 34
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OTHER_PRE_SPECIFIED outcome
Timeframe: Pre and post aerobic exercise on intervention sessions 1, 9, and 18. Each aerobic exercise session will be 15 minutesPopulation: Change in peripheral BDNF following aerobic exercise (Post aerobic exercise BDNF - Pre aerobic exercise BDNF)
Blood specimens will be obtained immediately before and after AEx on three separate occasions (sessions 1, 9, and 18). Briefly, an intravenous catheter will be placed in a superficial forearm vein at the beginning of the experimental session and will be maintained patent using an isotonic saline solution. Baseline blood samples will be drawn immediately before exercise commences. Immediate post-exercise blood samples will be taken within sixty seconds of exercise completion while the participant remains seated in the cycle ergometer.
Outcome measures
| Measure |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 Participants
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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Assessment of Peripheral Brain-derived Neurotrophic Factor
Session 1
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-4.7 ng/ml
Standard Deviation 8
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Assessment of Peripheral Brain-derived Neurotrophic Factor
Session 9
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-3.2 ng/ml
Standard Deviation 13.5
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Assessment of Peripheral Brain-derived Neurotrophic Factor
Session 18
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-2.3 ng/ml
Standard Deviation 7.2
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Adverse Events
Aerobic Exercise + Upper Extremity Rehabilitation
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 |
Aerobic Exercise + Upper Extremity Rehabilitation
n=10 participants at risk
Subjects will receive a total of 18 intervention sessions. In each intervention session, subjects will perform 15 minutes of aerobic exercise on a stationary cycle followed by 200 repetitions of an upper extremity rehabilitation program.
Aerobic Exercise + Duck Duck Punch: Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to "punch" virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session.
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General disorders
Dehydration
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10.0%
1/10 • Number of events 1 • Data was collected for each participant through study completion, an average of approximately 8 weeks.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place