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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
Sponsor:
Information provided by (Responsible Party):
Ryan Ross, Medical University of South Carolina

Brief Summary:
The purpose of this project is to establish initial feasibility and tolerability of a combined aerobic exercise (AEx) and upper extremity motor practice intervention on upper extremity (UE) function in chronic stroke survivors. This novel intervention pairs AEx with a virtual reality-based upper extremity rehabilitation game, Duck Duck Punch (DDP). AEx has been shown to improve overall brain function and promote a healthy brain environment; thus it may serve as an effective 'primer' and enhance the effects of DDP. Movement-based priming for rehabilitation involves performing movement or exercise before, or simultaneous to, an intervention with the goal of improving the effectiveness of the intervention. AEx combined with UE rehabilitation can improve UE function and self-reported health status in chronic stroke survivors. However, gaps remain regarding the clinical applicability of an AEx priming session and the mechanisms contributing to changes in UE functions in response to AEx-primed UE rehabilitation. Therefore, the aim of this project is to: 1) demonstrate the feasibility of pairing AEx + DDP in stroke survivors; 2) quantify the magnitude of the effect of the AEx + DDP intervention on UE function; 3) examine relationship of biomarkers of the nervous system and response to AEx + DDP.

Condition or disease Intervention/treatment Phase
Stroke Device: Aerobic Exercise + Duck Duck Punch Not Applicable

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • experienced unilateral stroke at least 6 months, but no more than 120 months prior
  • voluntary shoulder flexion of the affected arm ≥20° with simultaneous elbow extension ≥10°
  • moderate arm movement impairment (UE Fugl-Meyer Assessment > 21 but < 52 points
  • passive range of motion in paretic shoulder, elbow, wrist, thumb and fingers within 20 degrees of normal
  • 21-90 years of age
  • ability to communicate as per the therapists' judgement at baseline testing
  • ability to complete and pass an exercise tolerance test

Exclusion Criteria:

  • lesion in brainstem/cerebellum as these may interfere with visual-perceptual/cognitive skills needed for motor re-learning
  • presence of other neurological disease that may impair motor learning skills
  • orthopedic condition or impaired corrected vision that alters reaching ability (e.g., prior rotator cuff tear without full recovery)
  • paretic arm pain that interferes with reaching
  • unable to understand or follow 3-step directions
  • severe cognitive impairment (Montreal Cognitive Assessment score <22)
  • severe aphasia
  • inability to read English
  • history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
  • Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest
  • history of, or current, depression and for brain stimulation procedures only
  • women of child-bearing potential
  • electronic or metallic implants
  • history of seizures

Information from the National Library of Medicine

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


Contacts
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Contact: Ryan Ross, PhD 843-792-3477 rossre@musc.edu

Locations
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United States, South Carolina
Stroke Recovery Research Center
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Study Director: Chris Gregory, PhD, PT Medical University of South Carolina

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Responsible Party: Ryan Ross, Post-Doctoral Scholar, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04259424    
Other Study ID Numbers: Pro#00092739
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ryan Ross, Medical University of South Carolina:
Rehabilitation
Upper Extremity
Aerobic Exercise
Motor Function
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases