Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-08-20
2028-07-31
Brief Summary
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Detailed Description
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Specific Aim 1. Determine the efficacy of a single-visit, PT-initiated rehabilitation program vs. a multi-visit, PT-guided rehabilitation program for AT.
Specific Aim 2. Identify early prognostic factors for individuals who experience the greatest improvement in pain and disability by four weeks.
Study Design. A single-blind, two-arm, parallel phase 2 randomized controlled trial is the study approach. Individuals with AT will be randomized to one of two rehabilitation programs: 1) self-guided intervention initiated with a single visit with a physical therapist (PT) via telehealth followed by modules that the participant can complete asynchronously, or 2) PT-guided intervention (standard of care) with six one-on-one telehealth visits. Study will enroll 160 individuals with AT across two sites (University of Iowa Hospitals \& Clinics; Carl R. Darnall Army Medical Center, Fort Cavazos) and obtain baseline variables and immediate response at 2-weeks to characterize the sample. Outcomes will be assessed at 4 weeks (primary endpoint), 8 weeks, 26 weeks, and 1 year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation
Participants will complete 6 online modules, which will take 10 to 20 minutes each. The modules can be completed at their own pace over 8 weeks and include:
1. Exercise participation: Participants will receive instruction on how to progress a home exercise program. Participants will also need to complete a home exercise log.
2. Education: Participants will be given homework to do at home in between online module sessions. Online quizzes will help review the educational material.
Exercise
All participants will be instructed in a progressive Achilles tendon loading exercise program.
Education
All participants will receive education on Achilles tendinopathy terminology, common symptoms, diagnosis, expected recovery timeline, importance of physical activity, self-management strategies, multiple factors influencing pain, alternative and adjunct treatment options.
Multi-visit, Physical Therapist Guided Rehabilitation
Participants will attend 6 to 7 telehealth sessions over 8 weeks, which will last 30 to 45 minutes each and include:
1. Exercise participation: Instruction from a physical therapist will be provided on how to complete a home exercise program between treatment sessions. Participants will also need to complete a home exercise log.
2. Education: Participants will be given homework and online quizzes to do at home in between treatment sessions. The physical therapist will review the educational material at each visit.
Exercise
All participants will be instructed in a progressive Achilles tendon loading exercise program.
Education
All participants will receive education on Achilles tendinopathy terminology, common symptoms, diagnosis, expected recovery timeline, importance of physical activity, self-management strategies, multiple factors influencing pain, alternative and adjunct treatment options.
Interventions
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Exercise
All participants will be instructed in a progressive Achilles tendon loading exercise program.
Education
All participants will receive education on Achilles tendinopathy terminology, common symptoms, diagnosis, expected recovery timeline, importance of physical activity, self-management strategies, multiple factors influencing pain, alternative and adjunct treatment options.
Eligibility Criteria
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Inclusion Criteria
* AT pain greater than or equal to 3/10 with tendon-loading exercise
Exclusion Criteria
* BMI \> 45 kg/m2
* Pain primarily due to a differential diagnosis, including paratendonitis, bursitis (retrocalcaneal or subcutaneous), posterior ankle impingement or os trigonum, irritation or neuropathy of the sural nerve, plantaris tendon involvement)
* Presence of a partial Achilles tendon tear or rupture on imaging or a history of Achilles tendon rupture that was verified by surgical or conservative management
* Attended physical therapy for AT in the past 3 months
* History of steroid injection to lower extremity tendons/fascia, ESWT or any injection to the Achilles tendon region in the past 3 months
* History of taking fluoroquinolones in the past 6 months
* History of surgery or invasive procedure for AT on side enrolling for treatment
* Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy), connective tissue disorder (e.g., Marfan's syndrome, Ehlers Danlos), or pregnancy
* At high risk for falls (four step square test \>15 seconds)
* Refusal of randomization or unable or uninterested in completing virtual visits with a webcam or smart phone or completing quizzes and surveys
18 Years
60 Years
ALL
No
Sponsors
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C.R.Darnall Army Medical Center
FED
United States Department of Defense
FED
Ruth Chimenti
OTHER
Responsible Party
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Ruth Chimenti
Associate Professor, Physical Therapy and Rehabilitation Science
Principal Investigators
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Ruth L Chimenti, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Matthew Frazier, PT, DPT, MS, ATC
Role: STUDY_DIRECTOR
Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos
Locations
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University of Iowa Health Care - Gait Analysis Laboratory
Iowa City, Iowa, United States
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HT94252410536
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
202405285
Identifier Type: -
Identifier Source: org_study_id
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