Recruiting
Early Phase 1

Exercise Primed

Sponsor:

VA Office of Research and Development

Code:

NCT04877444

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Duck Duck Punch

Aerobic exercise

Lower extremity stretching

Study Details

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.

Conditions

Stroke

Study ID

NCT04877444

Start date

Jul 1, 2021

Status verified date

Jan, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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;
  • 50-90 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.

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 (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;
  • history of seizures;
  • women of child bearing potential.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aerobic exercise (AEx) + upper extremity rehabilitation

Subject 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.

experimental: Stretching (CON) + upper extremity rehabilitation

Subjects will perform 15 minutes of lower extremity stretching. Following lower extremity stretching subjects will receive 200 repetitions of DDP.

Interventions

Duck Duck Punch

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.

Aerobic exercise

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.

Lower extremity stretching

Subjects will perform 15 minutes of lower extremity stretching. Following aerobic exercise subject will play an upper extremity rehabilitation game called Duck Duck Punch.

Primary outcome measure

  • Change from baseline upper extremity impairment assessed by the Fugl Meyer Upper Extremity Assessment (FMA-UE) [ Time Frame: Approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Ryan E Ross, PhD

(843) 792-3477Ryan.Ross2@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Ryan E Ross, PhD

843-792-3477Ryan.Ross2@va.gov

Principal Investigator:

Ryan E Ross, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • rehabilitation
  • exercise
  • brain-derived neurotrophic factor
  • upper extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-09.