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AFO Adjustments for Musculoskeletal Disorders (AFOHeel Trial)
AFOHeel Trial Summary
This trial will test different heel heights and stiffness's of ankle foot orthosis (AFO) to see how it affects the forces and motion of the lower limb during over-ground walking for people who use AFOs regularly.
AFOHeel Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAFOHeel Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AFOHeel Trial Design
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Who is running the clinical trial?
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- I am between 18 and 70 years old.You meet the qualifications to be included in Group 1 of the study.I can walk at a slow to moderate pace.My ankle-foot orthosis fits in regular shoes.You can understand and communicate in written English and can give written permission to participate in the study.This is for a specific group of patients, called Group 1.I use an ankle-foot orthosis daily due to a leg injury or condition below my knee.I can walk 50 feet on my own without help from devices.I have been using my current ankle-foot orthosis for over 2 weeks.
- Group 1: Arm 18:
- Group 2: Arm 23:
- Group 3: Arm 24:
- Group 4: Arm 21:
- Group 5: Arm 7:
- Group 6: Arm 9:
- Group 7: Arm 14:
- Group 8: Arm 15:
- Group 9: Arm 10:
- Group 10: Arm 17:
- Group 11: Arm 20:
- Group 12: Arm 22:
- Group 13: Arm 8:
- Group 14: Arm 11:
- Group 15: Arm 12:
- Group 16: Arm 13:
- Group 17: Arm 16:
- Group 18: Arm 19:
- Group 19: Arm 1:
- Group 20: Arm 2:
- Group 21: Arm 3:
- Group 22: Arm 4:
- Group 23: Arm 5:
- Group 24: Arm 6:
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the ultimate goal of this clinical study?
"The primary metric monitored in this trial is the Centre of Pressure Velocity Magnitude (CPVM). Secondary outcomes include Activities-Specific Balance Confidence (ABC), PROMIS Patient Reported Outcomes for Physical Function, and Numerical Pain Rating Scale. The ABC survey evaluates balance confidence across everyday activities while PROMIS presents physical function through a computerized T-score system. Lastly, pain levels are assessed using an 11 point numerical scale with 0 being no pain and 10 being worst imaginable agony."
What criteria must one meet in order to be eligible for this experiment?
"Forty patients aged 18 to 70 with peripheral nervous system disorders may be eligible for this trial. To qualify, they must demonstrate the capacity to walk at least 50 feet without an aid and fit into traditional footwear, as well as meet GROUP 1 Inclusion criteria (e.g., having used their current AFO for more than two weeks and being able to move along slowly or moderately)."
Is it currently possible to register for this clinical experiment?
"Information on clinicaltrials.gov attests that this trial is currently searching for suitable applicants, having been originally posted in November 2019 and revised as recently as January 12th 2022."
To what extent do individuals aged eighty-five and up qualify for the experiment?
"The age requirement for this clinical trial is 18 to 70 years of age. There are an additional 39 studies offering their services to individuals below the established threshold and 314 investigations available for those beyond 65."
How many candidates are being included in this trial?
"Affirmative. Clinicaltrials.gov records refer to this clinical trial being actively recruiting, with the first post date of November 7th 2019 and last edit on January 12th 2022. The study requires 40 patients at a single site for participation."
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