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NCT Number: NCT06857916

Cycle and Stroke With Biofeedback for Power Symmetry

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health, Neilsen Rehabilitation Hospital

Salt Lake City, Utah, 84108, United States

Location status: Recruiting

Location contact

Heidi Hansen

CONTACT

[email protected]

801-585-2373

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

  • 18 to 70 years of age
  • a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
  • medical clearance to participate

Exclusion criteria

  • 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.

Treatment and study plan

Traditional

Other

Traditional rehabilitation course will occur.

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.

Primary outcomes

  1. Change in cycling power

    Time frame: 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

  2. Change in gait symmetry

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Heather A Hayes, PhD

CONTACT

[email protected]

801-587-9249

Tamara Garff

CONTACT

[email protected]

8015853122

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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