Exercise-primed Upper Extremity Motor Practice in Chronic Stroke (PUMP-Ex)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise + Duck Duck Punch
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Upper Extremity, Aerobic Exercise, Motor Function
Eligibility 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
Sites / Locations
- Stroke Recovery Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aerobic Exercise + Upper Extremity Rehabilitation
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Upper Extremity Impairment as Assessed by the Fugl-Meyer Assessment - Upper Extremity
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
Change in Upper Extremity as Assessed by the Wolf Motor Function Test
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
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.
Full Information
NCT ID
NCT04259424
First Posted
January 27, 2020
Last Updated
April 12, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04259424
Brief Title
Exercise-primed Upper Extremity Motor Practice in Chronic Stroke
Acronym
PUMP-Ex
Official Title
Priming Upper Extremity Motor Practice With Aerobic Exercise: A Feasibility and Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
With a surviving cohort of nearly 7 million individuals, stroke is the leading cause of long-term disability in the United States. Of the ~795,000 new strokes occurring annually, approximately 2/3rds of survivors will have some degree of long term disability. The prevalence of post-stroke disability coupled with the fact that more people are surviving stroke reflects an increasing need to develop effective rehabilitation strategies aimed at reducing disability and improving quality of life for the millions of stroke survivors, their families and caregivers.
The overwhelming majority of stroke survivors, >75%, exhibit upper extremity (UE) hemiparesis, and only 15% will recover fully. Furthermore, residual UE impairment is closely linked to long-term disability and reduced quality of life. Current meta-analytic evidence supports virtual reality stroke rehabilitation interventions for improving UE function suggesting that this is a promising area for further therapeutic development.
Duck Duck Punch (DDP) is an interactive computer game deliberately designed to enhance UE movement quality via individualized progressive movement practice along with an array of performance metrics allowing for within-session feedback on movement performance. Although response to UE virtual reality rehabilitation interventions, such as DDP, involves a multitude of factors, neuroplastic changes are a primary mechanism underlying functional recovery. Thus, pairing DDP with a priming intervention to facilitate a 'neuroplastic-friendly' environment may make the CNS more amenable, and enhance response to DDP rehabilitation and ultimately improve outcomes.
Aerobic exercise (AEx) training has positive benefits on overall brain function including enhanced global cognition, executive function, and processing speed and attention in healthy, older adults. Additionally, a single session of AEx acutely improves motor memory and learning in younger, healthy adults. Although AEx has been used to improve cardiovascular function following stroke, its neurofacilitatory effects in stroke have yet to be tested empirically. Candidate mechanisms through which AEx enhances brain function and motor learning include changes in circulating brain-derived neurotrophic factor (BDNF) and corticomotor excitability. BDNF is believed to play an integral role in several neuroplastic processes and promotes the strengthening of synaptic connections, i.e. long-term potentiation (LTP) and current research indicates that AEx can acutely and chronically increase circulating BDNF. Corticomotor excitability (CME) is often used as an indicator of LTP-like neuroplasticity and may underlie improvements in motor memory and learning. Similarly to BDNF, AEx can acutely enhance corticomotor excitability in control and chronic stroke subjects. Facilitating central nervous system function provides rationale to determine the role of AEx in 'prime' the brain for a subsequent intervention to maximize neuroplastic potential.
Movement-based priming for neurorehabilitation involves performing movement or exercise before, or concurrent to, a therapeutic intervention with the goal of improving the efficacy of the therapeutic intervention. Emerging evidence supports AEx as a potential priming tool for UE stroke rehabilitation. AEx combined with UE task training can improve UE function and self-reported health status in chronic stroke survivors. Despite the promising results, there are gaps in the literature involving: 1) the clinical applicability of an AEx priming session; and 2) mechanisms contributing to changes in UE functions in response to AEx-primed UE rehabilitation. Addressing these gaps will be necessary to develop an AEx primer that is potent and time efficient, with respect to current clinical models. Therefore, the purpose of this pilot proposal will be to establish initial feasibility and tolerability benchmarks via the following aims:
Demonstrate the feasibility of pairing AEx + DDP in stroke survivors with UE hemiparesis
Quantify the magnitude of the effect of the AEx + DDP intervention on UE impairment and function
Examine the relationship of biomarkers of neuroplasticity (BDNF and corticomotor excitability) and response to AEx + DDP
To accomplish these aims, chronic stroke survivors with moderate UE hemiparesis will undergo 18 sessions of AEx + DDP training. Each week, for six weeks, subjects will undergo three sessions of AEx + DDP. During each session subjects will complete 15 minutes of aerobic exercise followed by 200 repetitions of DDP. Assessment of UE function and biomarkers of neuroplasticity will be assessed before and after the AEx + DDP intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Upper Extremity, Aerobic Exercise, Motor Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects enrolled will receive the same treatment. Upper extremity motor function outcome measures will be assessed.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise + Upper Extremity Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aerobic Exercise + Duck Duck Punch
Intervention Description
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 Measure Information:
Title
Change in Upper Extremity Impairment as Assessed by the Fugl-Meyer Assessment - Upper Extremity
Description
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.
Time Frame
Pre and post intervention, approximately 6 weeks
Secondary Outcome Measure Information:
Title
Change in Upper Extremity as Assessed by the Wolf Motor Function Test
Description
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.
Time Frame
Pre and post intervention, approximately 6 weeks
Title
Change in Physical Function and Health-related Quality of Life as Assessed by Stroke Impact Scale
Description
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.
Time Frame
Pre and post intervention, approximately 6 weeks
Other Pre-specified Outcome Measures:
Title
Change in Neuroplastic Potential as Assessed by Paired Associative Stimulation
Description
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.
Time Frame
Pre and post intervention, approximately 6 weeks
Title
Assessment of Peripheral Brain-derived Neurotrophic Factor
Description
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.
Time Frame
Pre and post aerobic exercise on intervention sessions 1, 9, and 18. Each aerobic exercise session will be 15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Gregory, PhD, PT
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Stroke Recovery Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise-primed Upper Extremity Motor Practice in Chronic Stroke
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