StrokeNCT05420857
Effects of Biofeedback on Walking Speed Post-stroke
A study testing Overground Visual Biofeeback in people with Stroke, run by University of Nebraska at 1 site in United States.
Trial summary
Stroke is the leading cause of serious long-term disability in the United States. Walking speed is related to stroke severity and how well someone can return to community life. Biofeedback is a useful method for increasing walking speed in persons post-stroke, however, these methods are typically limited to laboratory… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Overground Visual Biofeeback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-80 years
- Chronic stroke (>6 months post-stroke)
- Be able to walk 10-meters with or without an assistive device
- Sufficient cognitive ability to understand instructions and communicate with the study team: moderate or better score on Montreal Cognitive Assessment (MOCA)/Mini-mental State Examination (MMSE)
Who cannot join
- Multiple strokes
- Complaints of cardiorespiratory or musculoskeletal disorders that would affect walking
- Visual deficits or hemi-neglect
- Other neurologic disorders beyond stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Official title: The Effects of Overground Visual Biofeedback on Walking Speed and Symmetry in Individuals Post-stroke
Stroke is the leading cause of serious long-term disability in the United States. Walking speed is related to stroke severity and how well someone can return to community life. Biofeedback is a useful method for increasing walking speed in persons post-stroke, however, these methods are typically limited to laboratory settings. The objective of this research is to determine the short-term response and training potential of a novel, wearable device that provides visual feedback of hip extension during unconstrained over ground walking. The aims of this study are to 1) determine short-term effects of visual biofeedback on biomechanical outcomes, 2) determine the short-term effects of visual biofeedback on gait symmetry during overground walking in individuals post-stroke. The investigators hypothesize that biomechanical and spatiotemporal outcomes will improve following training with the wearable biofeedback device. To assess these aims, participants' gait biomechanics will be assessed pre- and post-training with the biofeedback device as well as 24-hours following the training. Walking speed (primary outcome) as well as hip extension angle, propulsive force, step width, step length, and step time will be assessed to determine changes in performance with use of the device. By understanding short-term responses to this novel training paradigm, research can begin assessing the potential of wearable biofeedback devices in improving gait in persons post-stroke. Should this training prove successful, this study will provide the necessary feasibility data to motivate a larger scale, case-control clinical trial to determine efficacy of the device and training.
Read the detailed description
For all aims, participants will complete a first testing session where biomechanical variables will be assessed pre- and post-training with the hip extension device. A second testing session will be completed 24-hours following the first session where retention of training will be assessed. Biomechanical assessments, control sessions and training sessions are described as follows:
Biomechanical Assessments: Biomechanical Assessments will be performed to assess variables including walking speed, hip extension angle, and propulsion. Retro-reflective markers will be placed over anatomical landmarks using a lower-body marker set. Participants will be instructed to walk in a straight line over a set of embedded force platforms (AMTI) while a 17-camera motion capture system (Motion Analysis Corp.) records lower-body kinematics and kinetics. Participants will complete a total of three successful walking trials for each assessment with a successful trial being defined as having at least one clean foot strike in a force platform for each foot. No biofeedback will be provided during biomechanical assessments. During the biomechanical assessments, subjects may wear a harness suspended from the ceiling (no body-weight support) for safety. Control Session: Prior to training, participants will undergo assessments without biofeedback. This session will be used as a comparison for the effects of a single training session. Training: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The same training structure was successfully used in a previous study10. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle, to not bias the results. If the participant surpasses the target hip extension angle, the target will blink green, indicating a successful trial. The target hip extension angle is the average of the four greatest peak hip extension angles the individual has achieves within the current training bout. Once the participant exceeds the current target angle, a new target will be created at the new average value. This novel feedback paradigm encourages the individual to progressively increase their peak hip extension by providing a high, but previously achieved target goal that adapts to improved performance in real-time. During training bouts, research personnel will follow the participant for safety.
Clinical Assessment: Participants will complete a clinical assessment prior to biomechanical assessments and training. Measurements from this assessment will include hip flexion and extension range of motion, hip flexion and extension strength, plantarflexion strength, and spasticity and will be used as covariates in analysis if significant effects are demonstrated within a factor. Hip flexion and extension range of motion will be measured with a goniometer while the participant is positioned on a patient table supine for flexion and prone for extension. Research personnel will guide the limb being measured to end range of motion while also bracing the pelvis to prevent extra motion not coming from the hip. Hip flexion and extension and plantarflexion strength will be measured using an isokinetic dynamometer (Biodex Medical Systems) where participants will complete three maximal voluntary contractions in each direction for each limb with the maximum torque being recorded and used for analysis. Spasticity will be assessed by asking participants to rate the frequency of their spasms on a 5-point scale ranging from no spasms to spasms occurring more than 10 times per hour, then severity of spasms will be assessed by a researcher using a 3-point scale ranging from mild to severe.
- Conditions
- Stroke
- Being tested
- Overground Visual Biofeeback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overground Visual BiofeebackOther
Subjects participate in biofeedback training for 3 6-minute bouts in a single session.
| Study group | Role | What they receive |
|---|---|---|
| Hip Biofeedback | Experimental | Training: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle. If the participant surpasses the target hip extension angle, the target will blink green. Receives: Other: Overground Visual Biofeeback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
Walking speed as measured by motion capture
Measured: change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Secondary outcomes (5)
Peak Hip Extension
Peak hip extension as measured by motion capture
Measured: change in peak hip extension and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Peak Propulsive Force
Peak propulsion as measured by motion capture
Measured: change in peak propulsive force and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step width
Step width as measured by motion capture
Measured: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step length
Step length as measured by motion capture
Measured: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step time
step time as measured by motion capture
Measured: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jan 2023
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian A Knarr, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420857
- Sponsor's protocol ID
- 0902-19-EP
- Status last verified
- Oct 2024
- First submitted
- 7 Jun 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hinton EH, Buffum R, Kingston D, Stergiou N, Kesar T, Bierner S, Knarr BA. Real-Time Visual Kinematic Feedback During Overground Walking Improves Gait Biomechanics in Individuals Post-Stroke. Ann Biomed Eng. 2024 Feb;52(2):355-363. doi: 10.1007/s10439-023-03381-0. Epub 2023 Oct 23.
PubMed 37870663
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Overground Visual Biofeedback on Walking Speed and Symmetry in Individuals Post-stroke
- ClinicalTrials.gov ID
- NCT05420857
- Acronym / sponsor ID
- 0902-19-EP
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 15 Jun 2022 (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.
Stroke is the leading cause of serious long-term disability in the United States. Walking speed is related to stroke severity and how well someone can return to community life. Biofeedback is a useful method for increasing walking speed in persons post-stroke, however, these methods are typically limited to laboratory settings. The objective of this research is to determine the short-term response and training potential of a novel, wearable device that provides visual feedback of hip extension during unconstrained over ground walking. The aims of this study are to 1) determine short-term effects of visual biofeedback on biomechanical outcomes, 2) determine the short-term effects of visual biofeedback on gait symmetry during overground walking in individuals post-stroke. The investigators hypothesize that biomechanical and spatiotemporal outcomes will improve following training with the wearable biofeedback device. To assess these aims, participants' gait biomechanics will be assessed pre- and post-training with the biofeedback device as well as 24-hours following the training. Walking speed (primary outcome) as well as hip extension angle, propulsive force, step width, step length, and step time will be assessed to determine changes in performance with use of the device. By understanding short-term responses to this novel training paradigm, research can begin assessing the potential of wearable biofeedback devices in improving gait in persons post-stroke. Should this training prove successful, this study will provide the necessary feasibility data to motivate a larger scale, case-control clinical trial to determine efficacy of the device and training.
Detailed description
For all aims, participants will complete a first testing session where biomechanical variables will be assessed pre- and post-training with the hip extension device. A second testing session will be completed 24-hours following the first session where retention of training will be assessed. Biomechanical assessments, control sessions and training sessions are described as follows:
Biomechanical Assessments: Biomechanical Assessments will be performed to assess variables including walking speed, hip extension angle, and propulsion. Retro-reflective markers will be placed over anatomical landmarks using a lower-body marker set. Participants will be instructed to walk in a straight line over a set of embedded force platforms (AMTI) while a 17-camera motion capture system (Motion Analysis Corp.) records lower-body kinematics and kinetics. Participants will complete a total of three successful walking trials for each assessment with a successful trial being defined as having at least one clean foot strike in a force platform for each foot. No biofeedback will be provided during biomechanical assessments. During the biomechanical assessments, subjects may wear a harness suspended from the ceiling (no body-weight support) for safety. Control Session: Prior to training, participants will undergo assessments without biofeedback. This session will be used as a comparison for the effects of a single training session. Training: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The same training structure was successfully used in a previous study10. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle, to not bias the results. If the participant surpasses the target hip extension angle, the target will blink green, indicating a successful trial. The target hip extension angle is the average of the four greatest peak hip extension angles the individual has achieves within the current training bout. Once the participant exceeds the current target angle, a new target will be created at the new average value. This novel feedback paradigm encourages the individual to progressively increase their peak hip extension by providing a high, but previously achieved target goal that adapts to improved performance in real-time. During training bouts, research personnel will follow the participant for safety.
Clinical Assessment: Participants will complete a clinical assessment prior to biomechanical assessments and training. Measurements from this assessment will include hip flexion and extension range of motion, hip flexion and extension strength, plantarflexion strength, and spasticity and will be used as covariates in analysis if significant effects are demonstrated within a factor. Hip flexion and extension range of motion will be measured with a goniometer while the participant is positioned on a patient table supine for flexion and prone for extension. Research personnel will guide the limb being measured to end range of motion while also bracing the pelvis to prevent extra motion not coming from the hip. Hip flexion and extension and plantarflexion strength will be measured using an isokinetic dynamometer (Biodex Medical Systems) where participants will complete three maximal voluntary contractions in each direction for each limb with the maximum torque being recorded and used for analysis. Spasticity will be assessed by asking participants to rate the frequency of their spasms on a 5-point scale ranging from no spasms to spasms occurring more than 10 times per hour, then severity of spasms will be assessed by a researcher using a 3-point scale ranging from mild to severe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Biofeedback | Experimental | Other: Overground Visual BiofeebackTraining: Participants will complete three training bouts in a session. For these training bouts, participants will be instructed to walk around the perimeter of the 9m x 15m laboratory while wearing the custom gait biofeedback device and visual display glasses. The training bouts will each be 6 minutes in duration with a 5-minute break in between bouts. The biofeedback will be intermittent, with one minute on and one minute off, in order for the individual to not become dependent on the feedback and to promote motor learning. Participants will be told that the device measures the angle their paretic leg is at, and as they move their leg, the line on the screen will move. They will be shown as they move their leg farther back, the line moves up, closer to the target. Participants will not be given specific feedback on what walking strategies to use to increase hip extension angle. If the participant surpasses the target hip extension angle, the target will blink green. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19-80 years
- Chronic stroke (>6 months post-stroke)
- Be able to walk 10-meters with or without an assistive device
- Sufficient cognitive ability to understand instructions and communicate with the study team: moderate or better score on Montreal Cognitive Assessment (MOCA)/Mini-mental State Examination (MMSE)
Key exclusion criteria (4 listed)
- Multiple strokes
- Complaints of cardiorespiratory or musculoskeletal disorders that would affect walking
- Visual deficits or hemi-neglect
- Other neurologic disorders beyond 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 |
|---|---|---|
| Overground Visual BiofeebackSubjects participate in biofeedback training for 3 6-minute bouts in a single session. | Other | Hip Biofeedback |
Primary outcome
Walking Speed
Time frame: change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Walking speed as measured by motion capture
5 secondary outcomes
Peak Hip Extension
Time frame: change in peak hip extension and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Peak Propulsive Force
Time frame: change in peak propulsive force and inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step width
Time frame: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step length
Time frame: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Step time
Time frame: change in inter-limb symmetry from pre-training, immediately after completing the training (post-training), and 24-hour follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Results publication: PubMed 37870663Hinton EH, Buffum R, Kingston D, Stergiou N, Kesar T, Bierner S, Knarr BA. Real-Time Visual Kinematic Feedback During Overground Walking Improves Gait Biomechanics in Individuals Post-Stroke. Ann Biomed Eng. 2024 Feb;52(2):355-363. doi: 10.1007/s10439-023-03381-0. Epub 2023 Oct 23.
- 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. This study is not recruiting at the moment.
Brian A Knarr, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overground Visual Biofeeback in people with Stroke, run by University of Nebraska 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: change in walking speed from pre-training, immediately after completing the training (post-training), and 24-hour follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420857, which also lists 1 linked publication.
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 18 Oct 2024.