Cycle and Stroke With Biofeedback for Power Symmetry

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06857916
• Lead Sponsor: University of Utah

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.

Detailed Description

Specific Aim 1 will determine the change in cycling power using BFB on a group of participants with stroke in an Inpatient Rehabilitation Facility. Specific Aim 2 will determine the effect size of the change in gait symmetry with cycling training with power BFB pre- to post-cycle intervention. Specific Aim 3 will determine the effect size of the change in functional mobility with cycling training with power BFB pre- to post-cycle intervention. Understanding the impact of cycle training with power BFB is an important step in improving stroke rehabilitation. This study is significant because it will provide data about power asymmetries in participants' early post-acute stroke and the transfer of training with power BFB to gait impairments.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-12-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-11-14
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in cycling power	pre- (admission day 2) and post- (day 14)	Determine the change in cycling power using Biofeedback (BFB) on a group of participants with stroke in an Inpatient Rehabilitation Facility
Change in gait symmetry	pre- (admission day 2) and post- (day 14)	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).

Trial Locations

Locations (1)

University Health, Neilsen Rehabilitation Hospital; 🇺🇸 Salt Lake City, Utah, United States