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New treatment option for Multiple Sclerosis
Official title Blood Flow Restriction And Veterans With MS
ClinicalTrials.gov ID: NCT05433103
What this study is testing
- What it's testing
- There currently is a lack of evidence to support exercise interventions in people with advanced disability due to MS (i.e., need assistance to walk or use a wheelchair). This project proposes to study a strength training program using blood flow restriction (BFR) in people with advanced disability due to MS.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Confirmed diagnosis of MS
- Age 18-75
- Patient Determined Disease Steps (PDDS) 4 to 7
- PDDS 4: Early cane: I use a cane or a single crutch or some other form of support (such as touching a wall or leaning on someone's arm) for walking...
- PDDS 5: Late cane: To be able to walk 25 feet, I have to have a cane, crutch, or someone to hold onto. I can get around the house or other buildings...
You likely can't join if
- PDDS 8: Unable to sit in a wheelchair for more than one hour.
- PDDS 3 or less: MS does not interfere with my activities, especially my walking. I can work a full day, but athletic or physically demanding...
- Moderate to Severe cognitive impairment as identified by the St. Louis University Mental Status Exam Score \<=20
- History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders
- Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg.
- Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete...
See the full eligibility criteria
- Confirmed diagnosis of MS
- Age 18-75
- Patient Determined Disease Steps (PDDS) 4 to 7
- PDDS 4: Early cane: I use a cane or a single crutch or some other form of support (such as touching a wall or leaning on someone's arm) for walking all the time or part of the time, especially when walking outside. I...
- PDDS 5: Late cane: To be able to walk 25 feet, I have to have a cane, crutch, or someone to hold onto. I can get around the house or other buildings by holding onto furniture or touching the walls for support. I may use...
- PDDS 6: Bilateral support: To be able to walk as far as 25 feet I must have two canes or crutches or a walker. I may use a scooter or wheelchair for longer distances.
- PDDS 7: Wheelchair/scooter: My main form of mobility is a wheelchair. I may be able to stand and/or take one or two steps, but I can't walk 25 feet, even with crutches or a walker.
- PDDS 8: Unable to sit in a wheelchair for more than one hour.
- PDDS 3 or less: MS does not interfere with my activities, especially my walking. I can work a full day, but athletic or physically demanding activities are more difficult than they used to be. I usually don't need a can...
- Moderate to Severe cognitive impairment as identified by the St. Louis University Mental Status Exam Score \<=20
- History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders
- Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg.
- Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic...
- Patient report of easy bruising
- Severe lower extremity spasticity as defined as Modified Ashworth scale \>2.
- Engaged in progressive resistance training program currently or in the previous 2 months prior to enrollment.
- Use of blood flow restriction currently or in the previous 2 months prior to enrollment.
- MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment.
- Inability to tolerate pressure cuff during baseline assessment.
- Unable to perform seated leg press exercise or no against gravity knee extension strength in at least one limb.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.