Exercise-primed Upper Extremity Motor Practice in Chronic Stroke

NCT04259424 | Completed Results FDA Device

• 1 other identifier: Pro#00092739
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation; Upper Extremity; Aerobic Exercise; Motor Function

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre and post intervention, approximately 6 weeks

Secondary Outcomes (2)

• Change in Upper Extremity as Assessed by the Wolf Motor Function Test

  Pre and post intervention, approximately 6 weeks

• Change in Physical Function and Health-related Quality of Life as Assessed by Stroke Impact Scale

  Pre and post intervention, approximately 6 weeks

Other Outcomes (2)

• Change in Neuroplastic Potential as Assessed by Paired Associative Stimulation

  Pre and post intervention, approximately 6 weeks

• Assessment of Peripheral Brain-derived Neurotrophic Factor

  Pre and post aerobic exercise on intervention sessions 1, 9, and 18. Each aerobic exercise session will be 15 minutes

Study Arms (1)

Aerobic Exercise + Upper Extremity Rehabilitation

EXPERIMENTAL

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

Interventions

Aerobic Exercise + Duck Duck Punch DEVICE

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.

Aerobic Exercise + Upper Extremity Rehabilitation

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• ability to communicate as per the therapists' judgement at baseline testing
• ability to complete and pass an exercise tolerance test

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 (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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Stroke Recovery Research Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ryan Ross
• Organization: Medical University of South Caroina

rossre@musc.edu

843-792-3477

Study Officials

• Chris Gregory, PhD, PT

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Scholar

Model Details: All subjects enrolled will receive the same treatment. Upper extremity motor function outcome measures will be assessed.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 6, 2020
• Study Start: March 22, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 31, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)