RECRUITING

Cycle and Stroke With Biofeedback for Power Symmetry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06857916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation
  2. 2. 18 to 70 years of age
  3. 3. a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
  4. 4. medical clearance to participate
  1. 1. contractures that limit lower limb range of motion
  2. 2. cardiovascular, respiratory or metabolic instability, including unstable angina or hypertension above 200/110 at rest
  3. 3. uncontrolled diabetes
  4. 4. severe respiratory disorders that limit exercise
  5. 5. inability to ambulate \> 150 feet prior to stroke
  6. 6. prior history of peripheral or central nervous system injury
  7. 7. moderate to severe hemispatial neglect according to the Kessler Foundation Neglect Assessment
  8. 8. major cognitive impairment preventing the capability to understand training instructions; identified by inability to follow 3-step command
  9. 9. severe aphasia preventing communication with the therapist.

Contacts and Locations

Study Contact

Heather A Hayes, PhD
CONTACT
801-587-9249
heather.hayes@hsc.utah.edu
Tamara Garff
CONTACT
8015853122
tamara.garff@hsc.utah.edu

Principal Investigator

Heather A Hayes, PhD
PRINCIPAL_INVESTIGATOR
University of Utah
James C Martin, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University Health, Neilsen Rehabilitation Hospital
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Heather A Hayes, PhD, PRINCIPAL_INVESTIGATOR, University of Utah
  • James C Martin, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Stroke