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Cycle and Stroke With Biofeedback for Power Symmetry

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06857916
Enrollment
20
Registered
2025-03-05
Start date
2021-04-01
Completion date
2025-12-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

cycling, power, inpatient rehabilitation, biofeedback, gait symmetry

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.

Interventions

Traditional rehabilitation course will occur.

OTHERcycle 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.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

pilot randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in cycling powerpre- (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 symmetrypre- (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).

Countries

United States

Contacts

Primary ContactHeather A Hayes, PhD
heather.hayes@hsc.utah.edu801-587-9249
Backup ContactTamara Garff
tamara.garff@hsc.utah.edu8015853122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026