Exercise-primed Upper Extremity Motor Practice in Chronic Stroke (PUMP-Ex)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04259424|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Aerobic Exercise + Duck Duck Punch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects enrolled will receive the same treatment. Upper extremity motor function outcome measures will be assessed.|
|Masking:||None (Open Label)|
|Official Title:||Priming Upper Extremity Motor Practice With Aerobic Exercise: A Feasibility and Pilot Study|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: 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.
Device: 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.
- Change in upper extremity impairment as assessed by the Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Pre and post intervention, approximately 6 weeks ]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.
- Change in upper extremity as assessed by the Wolf Motor Function Test [ Time Frame: Pre and post intervention, approximately 6 weeks ]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.
- Change in physical function and health-related quality of life as assessed by Stroke Impact Scale [ Time Frame: Pre and post intervention, approximately 6 weeks ]The SIS assesses physical function as well as other dimension of health-related quality of life: emotion, communication, memory & thinking, and social role function. 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.
- Change in neuroplastic potential as assessed by paired associative stimulation [ Time Frame: Pre and post intervention, approximately 6 weeks ]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.
- Assessment of peripheral brain-derived neurotrophic factor [ Time Frame: Pre and post aerobic exercise on intervention sessions 1, 9, and 18. Each aerobic exercise session will be 15 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259424
|Contact: Ryan Ross, PhDfirstname.lastname@example.org|
|United States, South Carolina|
|Stroke Recovery Research Center|
|Charleston, South Carolina, United States, 29425|
|Study Director:||Chris Gregory, PhD, PT||Medical University of South Carolina|