StrokeBLT2NCT04553198
Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
A study testing Backward Locomotion Treadmill Training (BLTT) in people with Stroke and Chronic Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
Despite current walking rehabilitation strategies, the majority of stroke survivors are unable to walking independently in the community and remain at increased risk of falls. Backward treadmill training is a novel training approach used by elite athletes to enhance speed, agility, and balance; however, it is… 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)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 3 Jan 2023
- 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
- Ability to maintain ≥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
- Walking speed <0.4m/s (per 10MWT comfortable)
- 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
Despite current walking rehabilitation strategies, the majority of stroke survivors are unable to walking independently in the community and remain at increased risk of falls. Backward treadmill training is a novel training approach used by elite athletes to enhance speed, agility, and balance; however, it is currently unknown how this exercise interacts with the central nervous system or if it could benefit stroke survivors with residual walking impairment. Knowledge gained from this study will likely lead to more effective walking rehabilitation strategies in stroke and related disorders.
Read the detailed description
Walking impairment after a stroke impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite ongoing efforts to increase the quality and delivery of rehabilitative care, less than ten percent of stroke survivors ever achieve walking independence within the community and are at higher risk of falls, fractures, rehospitalization. Several factors may lead to walking impairment, but the two most prevalent causes are lower extremity asymmetry and imbalance. Herein, the investigators propose backward locomotion treadmill training (BLTT), as a promising approach for walking rehabilitation in stroke survivors.
Hence, our central hypothesis is that BLTT facilitates sensory signaling, leading to an improvement in walking speed. The investigators have preliminary proof of technique and feasibility data suggesting that BLTT is safe and feasible for stroke patients, with our results showing clinically meaningful improvement in overground walking speed after just six training sessions, with retention at the two-week follow-up. The next logical step in planning toward a future definitive clinical trial is to determine its preliminary efficacy compared with conventional forward walking treadmill training (FLTT) as control.
The investigators plan to test the preliminary efficacy of BLTT by conducting a prospective, randomized, blinded-endpoint, pilot study of 40 individuals with residual mild-moderate gait impairment, >6 months post-stroke, to BLTT (n=20) versus FLTT (n=20), for nine 30-minute training session (3 sessions/week). The investigators will utilize well-validated behavioral measures in stroke recovery and rehabilitation to test the following Aims:
Aim 1. Determine the training-related effects of BLTT on overground walking speed (primary outcome) To achieve this aim, the investigators will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. Our working hypothesis 1 is that BLTT will increase walking speed (>0.13m/s), compared to the control group (FLTT).
Aim 2. Determine the effects of training on walking symmetry, proprioceptive signaling, and dynamic 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(b) and completion time on the i-TUG (c).
- Conditions
- Stroke, Chronic Stroke, Walking, Difficulty, Gait, Hemiplegic
- Being tested
- Backward Locomotion Treadmill Training (BLTT)
- 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
9-training sessions of reverse treadmill training (no bodyweight support)over three 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 3 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 3 weeks. Receives: Behavioral: Backward Locomotion Treadmill Training (BLTT) |
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)
wo 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 posted17 Sep 2020
- Study start1 Sep 2020
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology
- Responsible party
- Principal investigator, Oluwole Awosika, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553198
- Sponsor's protocol ID
- 2020-0450
- Acronym
- BLT2
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2020
- Last updated
- 13 Sep 2023
- Results posted
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Role of Sensory Systems Processing in Post-Stroke Walking Recovery
- ClinicalTrials.gov ID
- NCT04553198
- Acronym / sponsor ID
- BLT2 / 2020-0450
- 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
- 44 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American Academy of Neurology
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 17 Sep 2020 (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.
Despite current walking rehabilitation strategies, the majority of stroke survivors are unable to walking independently in the community and remain at increased risk of falls. Backward treadmill training is a novel training approach used by elite athletes to enhance speed, agility, and balance; however, it is currently unknown how this exercise interacts with the central nervous system or if it could benefit stroke survivors with residual walking impairment. Knowledge gained from this study will likely lead to more effective walking rehabilitation strategies in stroke and related disorders.
Detailed description
Walking impairment after a stroke impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite ongoing efforts to increase the quality and delivery of rehabilitative care, less than ten percent of stroke survivors ever achieve walking independence within the community and are at higher risk of falls, fractures, rehospitalization. Several factors may lead to walking impairment, but the two most prevalent causes are lower extremity asymmetry and imbalance. Herein, the investigators propose backward locomotion treadmill training (BLTT), as a promising approach for walking rehabilitation in stroke survivors.
Hence, our central hypothesis is that BLTT facilitates sensory signaling, leading to an improvement in walking speed. The investigators have preliminary proof of technique and feasibility data suggesting that BLTT is safe and feasible for stroke patients, with our results showing clinically meaningful improvement in overground walking speed after just six training sessions, with retention at the two-week follow-up. The next logical step in planning toward a future definitive clinical trial is to determine its preliminary efficacy compared with conventional forward walking treadmill training (FLTT) as control.
The investigators plan to test the preliminary efficacy of BLTT by conducting a prospective, randomized, blinded-endpoint, pilot study of 40 individuals with residual mild-moderate gait impairment, >6 months post-stroke, to BLTT (n=20) versus FLTT (n=20), for nine 30-minute training session (3 sessions/week). The investigators will utilize well-validated behavioral measures in stroke recovery and rehabilitation to test the following Aims:
Aim 1. Determine the training-related effects of BLTT on overground walking speed (primary outcome) To achieve this aim, the investigators will compare the Pre-Post change in walking speed [10- meter walk test (10MWT)] between groups. Our working hypothesis 1 is that BLTT will increase walking speed (>0.13m/s), compared to the control group (FLTT).
Aim 2. Determine the effects of training on walking symmetry, proprioceptive signaling, and dynamic 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(b) and completion time on the i-TUG (c).
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 3 weeks. |
| Forward Locomotion Treadmill Training (FLTT) | Sham comparator | Behavioral: Backward Locomotion Treadmill Training (BLTT)Participants train on a treadmill (no bodyweight support), three times per week x 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years of age
- Ability to maintain ≥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.
Key exclusion criteria (6 listed)
- Walking speed <0.4m/s (per 10MWT comfortable)
- 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)
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)9-training sessions of reverse treadmill training (no bodyweight support)over three weeks. | Behavioural | Backward Locomotion Treadmill Training (BLTT), 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 13 Sep 2023.
- 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) 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 5 inclusion and 6 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 13 Sep 2023. 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 13 Sep 2023.