Cycle and Stroke With Biofeedback for Power Symmetry

NCT ID: NCT06857916

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional rehabilitation

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

Group Type: ACTIVE_COMPARATOR

Traditional

Intervention Type: OTHER

Traditional rehabilitation course will occur.

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.

Group Type: EXPERIMENTAL

cycle with biofeedback

Intervention Type: 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.

Interventions

Traditional

Traditional rehabilitation course will occur.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather A Hayes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

James C Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University Health, Neilsen Rehabilitation Hospital

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heather A Hayes, PhD

Role: CONTACT

heather.hayes@hsc.utah.edu

801-587-9249

Tamara Garff

Role: CONTACT

tamara.garff@hsc.utah.edu

8015853122

Facility Contacts

Heidi Hansen

Role: primary

Heidi.Hansen@hsc.utah.edu

801-585-2373

Other Identifiers

00135445

Identifier Type: -

Identifier Source: org_study_id