Cycle and Stroke With Biofeedback for Power Symmetry

NCT06857916 | Recruiting

• 1 other identifier: 00135445
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine changes in power symmetry, gait symmetry, and functional outcomes for participants' poststroke (Inpatient Rehabilitation Facility) after participating in an intervention using a recumbent cycle with power biofeedback (BFB). To determine how this intervention can impact gait asymmetry, a common disorder poststroke secondary to hemiparesis. Gait asymmetry is a difficult impairment to treat because it is difficult for both therapists and patients to perceive. Training with BFB allows for quantitative data about the power production or lack of that directly impacts safety in walking, increased energy expenditure, and decreased gait speed.

Conditions

Stroke

Keywords

cycling; power; inpatient rehabilitation; biofeedback; gait symmetry

Outcome Measures

Primary Outcomes (2)

• Change in cycling power

  Determine the change in cycling power using Biofeedback (BFB) on a group of participants with stroke in an Inpatient Rehabilitation Facility

  pre- (admission day 2) and post- (day 14)

• Change in gait symmetry

  Determine the effect size of the change in gait symmetry pre- to post-intervention after cycling with Biofeedback (BFB). Participants will be assessed on gait symmetry patterns (magnitude and timing of propulsion), using an instrumented treadmill (Bertec).

  pre- (admission day 2) and post- (day 14)

Study Arms (2)

Traditional rehabilitation

ACTIVE COMPARATOR

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility.

Other: Traditional

cycle with biofeedback

EXPERIMENTAL

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. They will also participate in the cycle intervention with biofeedback. This will take place as an additional rehabilitation session.

Other: cycle with biofeedback

Interventions

Traditional OTHER

Traditional rehabilitation course will occur.

Traditional rehabilitation

cycle with biofeedback OTHER

Individuals will receive biofeedback about their power production and power symmetry while participating in a 32 minute recumbent cycling session in inpatient rehabilitation facility.

cycle with biofeedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation
• AND demonstrating lower extremity hemiparesis \[\< 100 on lower limb Motricity Index24\]
• to 70 years of age
• a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
• medical clearance to participate

You may not qualify if:

• contractures that limit lower limb range of motion
• cardiovascular, respiratory or metabolic instability, including unstable angina or hypertension above 200/110 at rest
• uncontrolled diabetes
• severe respiratory disorders that limit exercise
• inability to ambulate \> 150 feet prior to stroke
• prior history of peripheral or central nervous system injury
• moderate to severe hemispatial neglect according to the Kessler Foundation Neglect Assessment
• major cognitive impairment preventing the capability to understand training instructions; identified by inability to follow 3-step command
• severe aphasia preventing communication with the therapist.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University Health, Neilsen Rehabilitation Hospital

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Heather A Hayes, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• James C Martin, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather A Hayes, PhD

CONTACT

801-587-9249; heather.hayes@hsc.utah.edu

Tamara Garff

CONTACT

8015853122; tamara.garff@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot randomized controlled trial

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: March 5, 2025
• Study Start: April 1, 2021
• Primary Completion: November 14, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)