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Behavioural Intervention
Ankle Splint Stretching for Peripheral Arterial Disease
N/A
Recruiting
Led By Judy Delp, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is testing whether or not stretching can improve symptoms for people with peripheral arterial disease.
Who is the study for?
This trial is for people over 40 with stable Peripheral Arterial Disease (PAD) for at least 3 months and an ankle-brachial index of 0.90 or less. It's not suitable for those with limited joint motion, oxygen needs during exercise, regular exercisers, recent cardiovascular rehab participants, amputees, critical limb ischemia sufferers, rest leg pain patients, cardiorespiratory disease or diabetes sufferers, recent major illness treatments or surgeries.Check my eligibility
What is being tested?
The study tests if static muscle stretching using ankle splints can improve muscle oxygenation and walking ability in PAD patients. In this single-blinded study involving 40 participants over four weeks, one group will perform active stretching while the control group wears the splint without stretching.See study design
What are the potential side effects?
While specific side effects are not listed in the provided information about this clinical trial on static muscular stretching using ankle splints for PAD treatment; typically such non-invasive interventions may cause discomfort or minor pain due to stretching.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Continuous Walking Distance
Change in Muscle Oxygenation
Change in Total Walking Distance
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stretch GroupExperimental Treatment1 Intervention
Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.
Group II: No Stretch GroupPlacebo Group1 Intervention
Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
199 Previous Clinical Trials
31,651 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
26 Patients Enrolled for Peripheral Arterial Disease
Mayo ClinicOTHER
3,207 Previous Clinical Trials
3,767,100 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
240 Patients Enrolled for Peripheral Arterial Disease
Judy Delp, PhDPrincipal Investigator - Florida State University, College of Medicine
Florida State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 40 years old or older.You have difficulty moving your ankle or knee joints.You need oxygen when you do activities or exercise.Your condition has not changed for at least 3 months.You regularly exercise for at least 30 minutes, on 3 or more days each week.You have participated in a heart rehabilitation program in the last 3 months.You have had an amputation below or above the knee, or you have severe circulation problems in your legs with ulcers or gangrene.You have pain in your legs even when you are not moving.You had a major surgery or lower leg blood vessel procedure in the last 3 months.You have severe heart failure.You are unable to walk or use a wheelchair.You have a problem with thinking and understanding.You have a heart or lung condition.You have diabetes.You have had a significant medical condition treated in the past year.You have a disease that affects your brain or spinal cord.You have certain types of blood vessel inflammation or other related conditions.Your ankle-brachial index (ABI) test shows poor blood flow to your legs.
Research Study Groups:
This trial has the following groups:- Group 1: Stretch Group
- Group 2: No Stretch Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my profile compatible with the conditions of this medical study?
"Those suffering from peripheral arterial disease (PAD) between the ages of 40 and 100 are eligible to apply for this clinical trial. A total of 40 participants will be subsequently accepted into the program."
Answered by AI
To what degree is the capacity of this trial being utilized?
"Affirmative, clinicaltrials.gov indicates that this research endeavour is presently accepting participants. It was first made available to the public on July 29th 2020 and was modified as recently as March 16th 2022. There are 40 slots open across one medical centre."
Answered by AI
Is this research project open to participants aged 55 and older?
"This clinical study is searching for candidates aged between 40 and 100 years old."
Answered by AI
Is this experiment currently seeking participants?
"The clinical trial is actively seeking volunteers, with the initial post date being July 29th 2020 and most recent edit being March 16th 2022. Such information can be found on clinicaltrials.gov."
Answered by AI
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