Stroke, CardiovascularNCT03466372
Innovative Gait Biofeedback Strategies for Stroke Rehabilitation
A study testing biofeedback in people with Stroke, Cardiovascular and Gait, Hemiplegic, run by Emory University at 1 site in United States.
Trial summary
The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cardiovascular, Gait, Hemiplegic
- What is being tested?
- biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 3 Oct 2018
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke participants:
- age 30-90 years (stroke) or 18-50 years (able-bodied controls)
- chronic stroke (>6 months post stroke)
- ambulatory with or without the use of a cane or walker
- able to walk for 2 minutes at the self-selected speed without an orthoses
- resting heart rate 40-100 beats per minute
Show all 10Show fewer
- Able-bodied participants:
- age 18 to 50 years
- no history of neurologic disease
- no history of orthopedic disease or injury affecting the lower extremity.
Who cannot join
- Stroke participants:
- Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
- History of lower extremity joint replacement
- Inability to communicate with investigators
- Neglect/hemianopia, or unexplained dizziness in last 6 months
- Neurologic conditions other than stroke
Show all 12Show fewer
- Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking or cause pain during walking.
- Able-bodied controls
- History of neurologic disease
- History of orthopedic disease or injury to the lower extremity in the past 6 months
- Pain or discomfort during walking
- Cardiovascular or medical condition affecting ability to exercise or walk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Biofeedback Strategies for Gait Training
The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).
Read the detailed description
Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Biomechanical impairments, such as reduced knee and ankle flexion during swing phase negatively affect gait function and increase the risk for falls. During the stance phase, decreased contribution of the paretic leg to forward propulsion during paretic terminal stance is a critical post-stroke gait deficit shown to be correlated with hemiparetic severity, walking speed, and gait asymmetry. These gait deficits can lead to falls, increased energy cost of gait, and decreased endurance. Also, a slowed self-selected walking speed is one of the hallmarks of post-stroke gait, and greatly limits community participation in individuals post-stroke. Very few interventions provide targeted practice of biomechanically appropriate movement patterns exclusively or preferentially to the paretic leg. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. Real-time biofeedback gait training has been used for modulating step length asymmetry in people post-stroke. A recent study developed a protocol combining treadmill training with visual and auditory real-time biofeedback to increase anterior ground reaction force (AGRF). AGRF biofeedback may be a beneficial strategy to target unilateral propulsion deficits in people post-stroke. The goal of this study is to develop improved methodologies for AGRF gait biofeedback and to evaluate the feasibility and short-term effects of gait biofeedback. To achieve this goal, experiments will be performed on young able-bodied individuals as well as stroke survivors.
- Conditions
- Stroke, Cardiovascular, Gait, Hemiplegic
- Being tested
- biofeedback
- Keywords
- gait biofeedback, gait rehabilitation, paretic propulsion, gait motor learning
- Medical subject headings
- Myocardial Infarction, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedbackBehavioural
treadmill walking with biofeedback regarding propulsion and other gait parameters
| Study group | Role | What they receive |
|---|---|---|
| biofeedback 1 | Experimental | biofeedback training with progression of targets Receives: Behavioral: biofeedback |
| biofeedback 2 | Active comparator | biofeedback training with progression of targets and speeds Receives: Behavioral: biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
paretic pushoff (AGRF)
peak GRF generated by the leg affected by the stroke
Measured: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
Secondary outcomes (2)
non-paretic peak AGRF
peak GRF generated by the leg not affected by the stroke
Measured: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
paretic trailing limb angle
angle measuring limb orientation with respect to vertical at terminal stance
Measured: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start22 Mar 2018
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trisha Kesar, PT, PhD, Emory University
- Investigators
- Trisha Kesar, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466372
- Sponsor's protocol ID
- IRB00102559
- Status last verified
- May 2019
- First submitted
- 1 Mar 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19.
PubMed 29457532Schenck C, Kesar TM. Effects of unilateral real-time biofeedback on propulsive forces during gait. J Neuroeng Rehabil. 2017 Jun 6;14(1):52. doi: 10.1186/s12984-017-0252-z.
PubMed 28583196Santucci V, Alam Z, Liu J, Spencer J, Faust A, Cobb A, Konantz J, Eicholtz S, Wolf S, Kesar TM. Immediate improvements in post-stroke gait biomechanics are induced with both real-time limb position and propulsive force biofeedback. J Neuroeng Rehabil. 2023 Mar 31;20(1):37. doi: 10.1186/s12984-023-01154-3.
PubMed 37004111
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Biofeedback Strategies for Gait Training
- ClinicalTrials.gov ID
- NCT03466372
- Acronym / sponsor ID
- IRB00102559
- Conditions
- Stroke, Cardiovascular, Gait, Hemiplegic
- Keywords
- gait biofeedback, gait rehabilitation, paretic propulsion, gait motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 15 Mar 2018 (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.
The long-term study goal is to develop a more engaging, motivating gait biofeedback methodologies specifically designed for post-stroke gait training. The current project aims to address fundamental questions regarding the optimal methodology to deliver AGRF biofeedback during gait, and the feasibility and preliminary efficacy of AGRF progression protocols for improved gait patterns and gait function. The study objectives are to (1) evaluate the immediate effects of biofeedback training methodology on gait biomechanics; and (2) evaluate the feasibility and short-term effects on gait performance of a real-time biofeedback protocol incorporating progression criteria (similar to those employed during clinical rehabilitative training).
Detailed description
Even after discharge from rehabilitation, residual gait deficits are prevalent in stroke survivors, leading to decreased walking speed and endurance. Because gait dysfunctions limit community mobility, stroke survivors and rehabilitation clinicians consider restoration of walking a major goal of rehabilitation. Biomechanical impairments, such as reduced knee and ankle flexion during swing phase negatively affect gait function and increase the risk for falls. During the stance phase, decreased contribution of the paretic leg to forward propulsion during paretic terminal stance is a critical post-stroke gait deficit shown to be correlated with hemiparetic severity, walking speed, and gait asymmetry. These gait deficits can lead to falls, increased energy cost of gait, and decreased endurance. Also, a slowed self-selected walking speed is one of the hallmarks of post-stroke gait, and greatly limits community participation in individuals post-stroke. Very few interventions provide targeted practice of biomechanically appropriate movement patterns exclusively or preferentially to the paretic leg. Biofeedback can enhance an individual's awareness of the impairment targeted during gait training, enabling self-correction of aberrant gait patterns. Real-time biofeedback gait training has been used for modulating step length asymmetry in people post-stroke. A recent study developed a protocol combining treadmill training with visual and auditory real-time biofeedback to increase anterior ground reaction force (AGRF). AGRF biofeedback may be a beneficial strategy to target unilateral propulsion deficits in people post-stroke. The goal of this study is to develop improved methodologies for AGRF gait biofeedback and to evaluate the feasibility and short-term effects of gait biofeedback. To achieve this goal, experiments will be performed on young able-bodied individuals as well as stroke survivors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback 1 | Experimental | Behavioral: biofeedbackbiofeedback training with progression of targets |
| biofeedback 2 | Active comparator | Behavioral: biofeedbackbiofeedback training with progression of targets and speeds |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age 30-90 years (stroke) or 18-50 years (able-bodied controls)
- chronic stroke (>6 months post stroke)
- ambulatory with or without the use of a cane or walker
- able to walk for 2 minutes at the self-selected speed without an orthoses
- resting heart rate 40-100 beats per minute
Key exclusion criteria (12 listed)
- Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
- History of lower extremity joint replacement
- Inability to communicate with investigators
- Neglect/hemianopia, or unexplained dizziness in last 6 months
- Neurologic conditions other than 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 |
|---|---|---|
| biofeedbacktreadmill walking with biofeedback regarding propulsion and other gait parameters | Behavioural | biofeedback 1, biofeedback 2 |
Primary outcome
paretic pushoff (AGRF)
Time frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
peak GRF generated by the leg affected by the stroke
2 secondary outcomes
non-paretic peak AGRF
Time frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
paretic trailing limb angle
Time frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)
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 14 May 2019.
- Background: PubMed 29457532Genthe K, Schenck C, Eicholtz S, Zajac-Cox L, Wolf S, Kesar TM. Effects of real-time gait biofeedback on paretic propulsion and gait biomechanics in individuals post-stroke. Top Stroke Rehabil. 2018 Apr;25(3):186-193. doi: 10.1080/10749357.2018.1436384. Epub 2018 Feb 19.
- Background: PubMed 28583196Schenck C, Kesar TM. Effects of unilateral real-time biofeedback on propulsive forces during gait. J Neuroeng Rehabil. 2017 Jun 6;14(1):52. doi: 10.1186/s12984-017-0252-z.
- Derived from this study: PubMed 37004111Santucci V, Alam Z, Liu J, Spencer J, Faust A, Cobb A, Konantz J, Eicholtz S, Wolf S, Kesar TM. Immediate improvements in post-stroke gait biomechanics are induced with both real-time limb position and propulsive force biofeedback. J Neuroeng Rehabil. 2023 Mar 31;20(1):37. doi: 10.1186/s12984-023-01154-3.
- 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.
Trisha Kesar principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback in people with Stroke, Cardiovascular and Gait, Hemiplegic, run by Emory University 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 10 inclusion and 12 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 14 May 2019. 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?
paretic pushoff (AGRF) (time frame: Immediately after the 6-minute biofeedback training bout (Post-0 minutes)). 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 NCT03466372, which also lists 3 linked publications.
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 14 May 2019.