Clinical trial NCT06857916: Cycle and Stroke With Biofeedback for Power Symmetry
Official title: Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: cycling
power
inpatient rehabilitation
biofeedback
gait symmetry
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: pilot randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in cycling power
timeFrame: pre- (admission day 2) and post- (day 14)
measure: Change in gait symmetry
timeFrame: pre- (admission day 2) and post- (day 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University Health, Neilsen Rehabilitation Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Heather A Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: James C Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References: