Stroke, IschemicNCT06214494
Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors
A study testing Blood Flow Restricted High Intensity Treadmill Training and HITT in people with Stroke, Ischemic and Ambulation Disorder, Neurologic, run by MedStar National Rehabilitation Network at 1 site in United States.
Trial summary
Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Ambulation Disorder, Neurologic, Chronic Stroke
- What is being tested?
- Blood Flow Restricted High Intensity Treadmill Training and HITT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older with history of single ischemic stroke >6months.
- Ambulate without physical assistance over 10M with or without mobility aides and bracing in 180 seconds or less.
Who cannot join
- Concurrent physical or occupational therapy.
- Vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded.
- Resting BP >160/100mmHg even with medication.
- People who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study.
- Individuals who score 9 (greater than normal or minimal impairment) or more on the Short Blessed Cognitive Assessment (6 item) will be unable to give informed consent.
- Any medical condition (including heart failure, unstable angina, aortic stenosis, arrhythmias, hypertrophic cardiomyopathy, depression of ST-segment, previous or active deep vein thrombosis (DVT) in the hemiparetic lower extremity, pulmonary embolism (PE), bypass surgery within last 3 months.) that, in the opinion of the investigator, might jeopardize the participants' safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Effects of Blood Flow Restricted High Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors: A Pilot Study
Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.
- Being tested
- Blood Flow Restricted High Intensity Treadmill Training, HITT
- Keywords
- Blood Flow Restriction Training, BFR, BFRt, High Intensity Treadmill Training
- Medical subject headings
- Ischemic Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restricted High Intensity Treadmill TrainingOther
Also called BFR-HITT
Blood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion (on hemiparetic limb only) 2x weekly for 16 Sessions totaling minimum of 75 minutes weekly.
HITTOther
High Intensity Treadmill Training 2x weekly for 16 Sessions totaling minimum of 75minutes weekly.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Cohort | Experimental | Blood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion 2x weekly for 16 Sessions totaling a minimum of 75 minutes weekly. Receives: Other: Blood Flow Restricted High Intensity Treadmill Training |
| Control Cohort | Active comparator | High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly. Receives: Other: HITT |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
Secondary outcomes (5)
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short duration.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
5 Time Sit to Stand
The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
Functional Gait Assessment
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The tool is a modification of the 8-item Dynamic Gait Index, developed to improve reliability and reduce ceiling effect. Each item is scored on an ordinal scale from 0 to 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation. The highest score = 30 indicating no impairment in postural stability during walking.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
BERG Balance Scale
The Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults. Item-level scores range from 0-4 and are determined by ability to perform the assessed activity Item scores are then summed with lower scores indicating higher fall risk. The maximum score = 56.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
Activities Balance Confidence Scale-16
The ABC Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence.
Overall score is calculated by adding item scores and then dividing by the total number of items.
Measured: Baseline, Week 4 (up to one week), Week 8( up to one week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- A Randomized Case Control Cohort Study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedStar National Rehabilitation Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Alkhazov, MedStar National Rehabilitation Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214494
- Sponsor's protocol ID
- BFR-HITT
- Status last verified
- Mar 2024
- First submitted
- 29 Dec 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restricted High Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT06214494
- Acronym / sponsor ID
- BFR-HITT
- Keywords
- Blood Flow Restriction Training, BFR, BFRt, High Intensity Treadmill Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MedStar National Rehabilitation NetworkUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Jan 2024 (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.
Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Case Control Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Interventional Cohort | Experimental | Other: Blood Flow Restricted High Intensity Treadmill TrainingBlood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion 2x weekly for 16 Sessions totaling a minimum of 75 minutes weekly. |
| Control Cohort | Active comparator | Other: HITTHigh-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years or older with history of single ischemic stroke >6months.
- Ambulate without physical assistance over 10M with or without mobility aides and bracing in 180 seconds or less.
Key exclusion criteria (6 listed)
- Concurrent physical or occupational therapy.
- Vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded.
- Resting BP >160/100mmHg even with medication.
- People who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study.
- Individuals who score 9 (greater than normal or minimal impairment) or more on the Short Blessed Cognitive Assessment (6 item) will be unable to give informed consent.
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 |
|---|---|---|
| Blood Flow Restricted High Intensity Treadmill TrainingAlso: BFR-HITTBlood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion (on hemiparetic limb only) 2x weekly for 16 Sessions totaling minimum of 75 minutes weekly. | Other | Interventional Cohort |
| HITTHigh Intensity Treadmill Training 2x weekly for 16 Sessions totaling minimum of 75minutes weekly. | Other | Control Cohort |
Primary outcome
6 Minute Walk Test
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
5 secondary outcomes
10 Meter Walk Test
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
5 Time Sit to Stand
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Functional Gait Assessment
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
BERG Balance Scale
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Activities Balance Confidence Scale-16
Time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke, Ischemic
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
Recruiting
Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
Stroke, Ischemic Cerebrovascular Accident
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
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 Blood Flow Restricted High Intensity Treadmill Training and HITT in people with Stroke, Ischemic and Ambulation Disorder, Neurologic, run by MedStar National Rehabilitation Network 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 2 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: status not confirmed, as of the sponsor's last update on 4 Mar 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?
Results are not available in the source record.
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?
6 Minute Walk Test (time frame: Baseline, Week 4 (up to one week), Week 8( up to one week)). 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 4 Mar 2024.