StrokeNCT06857916
Cycle and Stroke With Biofeedback for Power Symmetry
A study testing Traditional and cycle with biofeedback in people with Stroke, run by University of Utah at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Traditional and cycle with biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Health, Neilsen Rehabilitation Hospital
Salt Lake City, Utah, 84108
Heidi Hansen, 801-585-2373, Heidi.Hansen@hsc.utah.edu
About this study
Official title: Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Traditional, cycle with biofeedback
- Keywords
- cycling, power, inpatient rehabilitation, biofeedback, gait symmetry
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraditionalOther
Traditional rehabilitation course will occur.
cycle with biofeedbackOther
Individuals will receive biofeedback about their power production and power symmetry while participating in a 32 minute recumbent cycling session in inpatient rehabilitation facility.
| Study group | Role | What they receive |
|---|---|---|
| Traditional rehabilitation | Active comparator | Participants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. Receives: Other: Traditional |
| cycle with biofeedback | Experimental | 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. Receives: Other: cycle with biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycling power
Determine the change in cycling power using Biofeedback (BFB) on a group of participants with stroke in an Inpatient Rehabilitation Facility
Measured: pre- (admission day 2) and post- (day 14)
Change in gait symmetry
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).
Measured: pre- (admission day 2) and post- (day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2021
- Primary completion14 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather A Hayes, PhD, Principal investigator, University of UtahJames C Martin, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857916
- Sponsor's protocol ID
- 00135445
- Status last verified
- Feb 2025
- First submitted
- 28 Dec 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06857916
- Acronym / sponsor ID
- 00135445
- Conditions
- Stroke
- Keywords
- cycling, power, inpatient rehabilitation, biofeedback, gait symmetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Traditional rehabilitation | Active comparator | Other: TraditionalParticipants will undergo traditional rehabilitation therapies in the inpatient rehabilitation facility. |
| cycle with biofeedback | Experimental | Other: cycle with biofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TraditionalTraditional rehabilitation course will occur. | Other | Traditional rehabilitation |
| cycle with biofeedbackIndividuals will receive biofeedback about their power production and power symmetry while participating in a 32 minute recumbent cycling session in inpatient rehabilitation facility. | Other | cycle with biofeedback |
Primary outcome
Change in cycling power
Time frame: pre- (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 symmetry
Time frame: pre- (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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather A Hayes, PhD principal investigator
University of Utah
James C Martin, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional and cycle with biofeedback in people with Stroke, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather A Hayes, PhD (801-587-9249, heather.hayes@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cycling power (time frame: pre- (admission day 2) and post- (day 14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.