Recruiting

Biofeedback

Sponsor:

University of Utah

Code:

NCT06857916

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Traditional

cycle with biofeedback

Study Details

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

Study ID

NCT06857916

Start date

Apr 1, 2021

Status verified date

Feb, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Nov 14, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation

-AND demonstrating lower extremity hemiparesis \[< 100 on lower limb Motricity Index24\]
2. 18 to 70 years of age
3. a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
4. medical clearance to participate

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Traditional rehabilitation

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

experimental: cycle with biofeedback

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.

Interventions

Traditional

Traditional rehabilitation course will occur.

cycle with biofeedback

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

Primary outcome measure

  • Change in cycling power [ Time Frame: pre- (admission day 2) and post- (day 14) ]
  • Change in gait symmetry [ Time Frame: pre- (admission day 2) and post- (day 14) ]

Central Contacts and Locations

Central contacts

Heather A Hayes, PhD

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

Tamara Garff

8015853122tamara.garff@hsc.utah.edu

Locations

University Health, Neilsen Rehabilitation Hospital

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Heidi Hansen

801-585-2373Heidi.Hansen@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Mar 5, 2025

Last verified

Feb, 2025

Keywords

  • cycling
  • power
  • inpatient rehabilitation
  • biofeedback
  • gait symmetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-03-05.