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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Cohort | Active Comparator | High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restricted High Intensity Treadmill Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4 (up to one week), Week 8( up to one week) |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test | The 10MWT assesses walking speed in meters per second over a short duration. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Limb Circumference | Limb circumference (cm) of hemiparetic lower extremity and unaffected lower extremity will be taken to determine if limb hypertrophy has occurred. | Baseline, Week 4 (up to one week), Week 8( up to one week) |
| 1 Repetition Maximum Strength Testing (Leg press) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar National Rehabilitation Hospital | Washington D.C. | District of Columbia | 20010 | United States |
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A Randomized Case Control Cohort Study
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|
| HITT | Other | High Intensity Treadmill Training 2x weekly for 16 Sessions totaling minimum of 75minutes weekly. |
|
| 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. | 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. | 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. | Baseline, Week 4 (up to one week), Week 8( up to one week) |
1 Repetition Maximum Strength Testing (Leg press) is a measure of overall hemiparetic gross push strength and is measured as the greatest force (in lbs) a patient can push with hemiparetic lower extremity one time. |
| Baseline, Week 4 (up to one week), Week 8( up to one week) |
| 1 Repetition Maximum Strength Testing (Knee Extension) | 1 Repetition Maximum Strength Testing (Knee Extension) is a measure of isolated hemiparetic quadriceps strength and is measured as the greatest force (in lbs) a patient can extend their hemiparetic quadriceps one time. | Baseline, Week 4 (up to one week), Week 8( up to one week) |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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