Cycle and Stroke With Biofeedback for Power Symmetry

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Stroke

Treatments: Other: cycle with biofeedback; Other: Traditional

Study type: Interventional

Funder types: Other

Identifiers

NCT06857916

00135445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Traditional rehabilitation

Active Comparator group

Description:

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility.

Treatment:

Other: Traditional

cycle with biofeedback

Experimental group

Description:

Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. They will also participate in the cycle intervention with biofeedback. This will take place as an additional rehabilitation session.

Treatment:

Other: cycle with biofeedback