StrokeBLT2bNCT04721860
Optimizing Training in Severe Post-Stroke Walking Impairment
A study testing Backward Locomotion Treadmill Training (BLTT) and Forward Locomotion Treadmill Training (FLTT) in people with Stroke and Chronic Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Chronic Stroke, Walking, Difficulty
- What is being tested?
- Backward Locomotion Treadmill Training (BLTT) and Forward Locomotion Treadmill Training (FLTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 30 Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- Walking speed less than or equal to 0.4 meters/second
- Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill
- Able to walk independently (cane and hemi-walker acceptable)
- Ambulate >10 meters over ground with the Free Step Harness System (as a safety precaution)
- Discharged from formal rehabilitation
Who cannot join
- Unstable cardiac status which would preclude participation in a moderate-intensity exercise program.
- Significant language barrier which might prevent the participant from following instructions during training and testing.
- Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect)
- Severe lower extremity spasticity (Ashworth >2)
- Depression (>10 on the Patient Health Questionnaire, if untreated).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
About this study
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
Read the detailed description
Severe walking impairment after stroke is defined as the inability to walk faster than 0.4 meters per second and impacts nearly twenty-five percent of chronic stroke survivors. Walking speed is a key determiner of community independence, and stroke survivors classified as "severe" are more often symptomatically home-bound with limited mobility and are at higher risk of falls, fractures, and rehospitalizations. A recent study by the investigators suggests that backward locomotion treadmill training (BLTT) may be a promising rehabilitative approach in stroke survivors with severe walking impairment; however, the effect of training duration on behavioral outcomes is unknown.
The objective of this study is to obtain critical pilot data on the effects of extended BLTT on walking speed, symmetry, and balance (static and dynamic), in chronic stroke survivors with baseline severe walking impairment, relative to forward treadmill training controls (FLTT).
Aim 1. Determine the training-related effects of extended BLTT on overground walking speed (primary outcome) in survivors with severe walking impairment. To achieve this aim, we will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. The working hypothesis is that extended BLTT will increase walking speed to a clinically meaningful level (≥0.16m/s), compared to the control group (FLTT).
Aim 2. Determine the effects of extended BLTT on walking symmetry and balance. The Zeno Walkway Gait Analysis software will capture Pre-Post changes in temporal gait symmetry index during the 10-MWT. Working hypothesis 2a: BLTT will be associated with a favorable improvement in the temporal symmetry index score. Proprioception and spinovestibular function will be measured with the modified Sensorineural Integration Test (mSIT), and dynamic balance will be assessed with the completion time on the instrumented Timed Up \& Go (i- TUG). Working hypothesis 2b and c: BLTT will be associated with a favorable improvement Pre-Post mSIT(a) and completion time on the i-TUG (b).
- Conditions
- Stroke, Chronic Stroke, Walking, Difficulty, Gait, Hemiplegic
- Being tested
- Backward Locomotion Treadmill Training (BLTT), Forward Locomotion Treadmill Training (FLTT)
- Keywords
- Gait, Balance, Non-body weight supported treadmill training, Backward locomotion treadmill training, Forward locomotion treadmill training, Walking Rehabilitation, Walking Recovery
- Medical subject headings
- Stroke, Mobility Limitation, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Locomotion Treadmill Training (BLTT)Behavioural
12-training sessions of reverse treadmill training (no bodyweight support) over four weeks.
Forward Locomotion Treadmill Training (FLTT)Behavioural
12-training sessions of forward treadmill training (no bodyweight support) over tfour weeks.
| Study group | Role | What they receive |
|---|---|---|
| Backward Locomotion Treadmill Training (BLTT) | Experimental | Participants train on a reverse treadmill (no bodyweight support), three times per week x 4 weeks. Receives: Behavioral: Backward Locomotion Treadmill Training (BLTT) |
| Forward Locomotion Treadmill Training (FLTT) | Sham comparator | Participants train on a treadmill (no bodyweight support), three times per week x 4 weeks. Receives: Behavioral: Forward Locomotion Treadmill Training (FLTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-Meter Walk (fast)
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Measured: Pre-Baseline (Day of Randomization) to One Day Post-Training
Secondary outcomes (2)
10-Meter Walk Test (Fast- Retention)
Two 10MWT (fast) trials (using a stop-watch) are averaged and documented in meters/second.
Measured: One Day Post Training, One month Post Training, 3- Months Post Training
10-Meter Walk (Comfortable)
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
Measured: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Oct 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- 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
- Parallel groups
- Model description
- Stratified Randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwole Awosika, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721860
- Sponsor's protocol ID
- 2020-0784
- Acronym
- BLT2b
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Training in Severe Post-Stroke Walking Impairment
- ClinicalTrials.gov ID
- NCT04721860
- Acronym / sponsor ID
- BLT2b / 2020-0784
- Conditions
- Stroke, Chronic Stroke, Walking, Difficulty, Gait, Hemiplegic
- Keywords
- Gait, Balance, Non-body weight supported treadmill training, Backward locomotion treadmill training, Forward locomotion treadmill training, Walking Rehabilitation, Walking Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Jan 2021 (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.
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
Detailed description
Severe walking impairment after stroke is defined as the inability to walk faster than 0.4 meters per second and impacts nearly twenty-five percent of chronic stroke survivors. Walking speed is a key determiner of community independence, and stroke survivors classified as "severe" are more often symptomatically home-bound with limited mobility and are at higher risk of falls, fractures, and rehospitalizations. A recent study by the investigators suggests that backward locomotion treadmill training (BLTT) may be a promising rehabilitative approach in stroke survivors with severe walking impairment; however, the effect of training duration on behavioral outcomes is unknown.
The objective of this study is to obtain critical pilot data on the effects of extended BLTT on walking speed, symmetry, and balance (static and dynamic), in chronic stroke survivors with baseline severe walking impairment, relative to forward treadmill training controls (FLTT).
Aim 1. Determine the training-related effects of extended BLTT on overground walking speed (primary outcome) in survivors with severe walking impairment. To achieve this aim, we will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. The working hypothesis is that extended BLTT will increase walking speed to a clinically meaningful level (≥0.16m/s), compared to the control group (FLTT).
Aim 2. Determine the effects of extended BLTT on walking symmetry and balance. The Zeno Walkway Gait Analysis software will capture Pre-Post changes in temporal gait symmetry index during the 10-MWT. Working hypothesis 2a: BLTT will be associated with a favorable improvement in the temporal symmetry index score. Proprioception and spinovestibular function will be measured with the modified Sensorineural Integration Test (mSIT), and dynamic balance will be assessed with the completion time on the instrumented Timed Up \& Go (i- TUG). Working hypothesis 2b and c: BLTT will be associated with a favorable improvement Pre-Post mSIT(a) and completion time on the i-TUG (b).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stratified Randomization
| Arm | Type | Receives |
|---|---|---|
| Backward Locomotion Treadmill Training (BLTT) | Experimental | Behavioral: Backward Locomotion Treadmill Training (BLTT)Participants train on a reverse treadmill (no bodyweight support), three times per week x 4 weeks. |
| Forward Locomotion Treadmill Training (FLTT) | Sham comparator | Behavioral: Forward Locomotion Treadmill Training (FLTT)Participants train on a treadmill (no bodyweight support), three times per week x 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years of age
- Walking speed less than or equal to 0.4 meters/second
- Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill
- Able to walk independently (cane and hemi-walker acceptable)
- Ambulate >10 meters over ground with the Free Step Harness System (as a safety precaution)
Key exclusion criteria (5 listed)
- Unstable cardiac status which would preclude participation in a moderate-intensity exercise program.
- Significant language barrier which might prevent the participant from following instructions during training and testing.
- Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect)
- Severe lower extremity spasticity (Ashworth >2)
- Depression (>10 on the Patient Health Questionnaire, if untreated).
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 |
|---|---|---|
| Backward Locomotion Treadmill Training (BLTT)12-training sessions of reverse treadmill training (no bodyweight support) over four weeks. | Behavioural | Backward Locomotion Treadmill Training (BLTT) |
| Forward Locomotion Treadmill Training (FLTT)12-training sessions of forward treadmill training (no bodyweight support) over tfour weeks. | Behavioural | Forward Locomotion Treadmill Training (FLTT) |
Primary outcome
Change in 10-Meter Walk (fast)
Time frame: Pre-Baseline (Day of Randomization) to One Day Post-Training
Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second.
2 secondary outcomes
10-Meter Walk Test (Fast- Retention)
Time frame: One Day Post Training, One month Post Training, 3- Months Post Training
10-Meter Walk (Comfortable)
Time frame: Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training
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 19 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Locomotion Treadmill Training (BLTT) and Forward Locomotion Treadmill Training (FLTT) in people with Stroke and Chronic Stroke, run by University of Cincinnati 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 6 inclusion and 5 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 19 Sep 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. Some participants in this study may receive a placebo. 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?
Change in 10-Meter Walk (fast) (time frame: Pre-Baseline (Day of Randomization) to One Day Post-Training). 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 19 Sep 2024.