Cycle and Stroke With Biofeedback for Power Symmetry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Traditional, cycle with biofeedback.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
Overview
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
- Other Traditional
Traditional rehabilitation course will occur. - 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.
Primary outcome measures
- Change in cycling power [Time frame: pre- (admission day 2) and post- (day 14)]
- Change in gait symmetry [Time frame: pre- (admission day 2) and post- (day 14)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Health, Neilsen Rehabilitation Hospital — Salt Lake City
Identifiers
NCT: NCT06857916 · 00135445