Exercise Primed Stroke Rehabilitation
Priming the Rehabilitation Engine: Aerobic Exercise as the Fuel to Spark Behavioral Improvements in Stroke
1 other identifier
interventional
40
1 country
1
Brief Summary
Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced physical and cognitive function and depression. Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors. Aerobic exercise (AEx) can improve physical and cognitive function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to an intervention. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 stroke
Started Jul 2021
Longer than P75 for early_phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
January 9, 2026
January 1, 2026
5.3 years
April 26, 2021
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline upper extremity impairment assessed by the Fugl Meyer Upper Extremity Assessment (FMA-UE)
The FMA-UE is a 33-item measure of UE 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 UE motor ability.
Approximately 8 weeks
Secondary Outcomes (7)
Change from baseline upper extremity motor function assessed by the Wolf Motor Function Test (WMFT)
Approximately 8 weeks
Change from baseline locomotor function assessed by self-selected walking (SSWS) speed and six-minute walk test (6MWT)
Approximately 8 weeks
Change from baseline health related quality of life assessed by the Stroke Impact Scale (SIS)
Approximately 8 weeks
Change from baseline depressive symptoms assessed by the Geriatric Depression Scale (GDS)
Approximately 8 weeks
Change from baseline cognitive function assessed by National Institutes of Health Toolbox - Cognition Battery (NIHTB-CB)
Approximately 8 weeks
- +2 more secondary outcomes
Study Arms (2)
Aerobic exercise (AEx) + upper extremity rehabilitation
EXPERIMENTALSubject will receive a total of 24 intervention sessions. In each session, subjects will perform 15 minutes of AEx followed by 200 repetitions of an upper extremity rehabilitation program.
Stretching (CON) + upper extremity rehabilitation
EXPERIMENTALSubjects will perform 15 minutes of lower extremity stretching. Following lower extremity stretching subjects will receive 200 repetitions of DDP.
Interventions
Duck Duck Punch (DDP) is an interactive computer game deliberately designed to enhance UE movement quality via individualized progressive movement practice. 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. The goal 'dose' of DDP will be 200 repetitions.
Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. The target intensity of aerobic exercise is 70% heart rate reserve. Following aerobic exercise subject will play an upper extremity rehabilitation game called Duck Duck Punch.
Subjects will perform 15 minutes of lower extremity stretching. Following aerobic exercise subject will play an upper extremity rehabilitation game called Duck Duck Punch.
Eligibility Criteria
You may qualify if:
- experienced unilateral stroke at least 6 months prior;
- voluntarily shoulder flexion of the affected arm 20 degrees with simultaneous elbow extension 10 degrees;
- 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;
- years of age;
- ability to communicate as per the therapists' judgement at baseline testing;
- ability to complete and pass an exercise tolerance test; 8) Box \& Block test score of at least 3 blocks in 60 seconds with the affected arm.
You may not qualify if:
- 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 (MoCA score 17);
- 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 COPD or oxygen dependence;
- History of DVT or pulmonary embolism within 6 months;
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- UBACC score \< 15; and for brain stimulation procedures only:
- electronic or metallic implants;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan E Ross, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The primary outcome measure will be assessed by a blinded rater to improve scientific rigor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2021
First Posted
May 7, 2021
Study Start
July 1, 2021
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share