CompletedNot Applicable

Manual Therapy After Ankle/Hindfoot Fractures

United States72 participantsStarted 2015-11

Plain-language summary

The aim of this randomized controlled trial is to assess if manual therapy improves mobility, gait, and balance more than a control group for patients who have undergone open reduction internal fixation (ORIF) after an ankle/hindfoot fracture.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-70 years
. Stiffness \> 5.0 cm side to side difference as measured by the ankle lunge test
. Surgical management of ankle or hindfoot fracture
. Full weight-bearing (WB)
. Able to read and speak sufficient English to complete outcome tools

Exclusion criteria

. Any prior foot/ankle surgery, deformity, or injury on the unaffected side which would affect gait, WB dorsiflexion or balance
. Unable to attend follow-up visits
. Any cognitive impairments which would prevents patients from being able to complete or understand questionnaires
. Have received any previous manual therapy for their current ankle and/or hindfoot fracture
. Have a known non/malunion
. Have additional fractures of the spine, hip, or knee that would likely affect their weight bearing or gait

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Range of motion (ROM)

Timeframe: 2 weeks

Spatial and temporal gait parameters - gait velocity

Timeframe: 2 weeks

Balance

Timeframe: 2 weeks

Trial details

NCT IDNCT02609347

SponsorIntermountain Health Care, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03

View on ClinicalTrials.gov More Ankle Fracture trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-70 years
. Stiffness \> 5.0 cm side to side difference as measured by the ankle lunge test
. Surgical management of ankle or hindfoot fracture
. Full weight-bearing (WB)
. Able to read and speak sufficient English to complete outcome tools

Exclusion criteria

. Any prior foot/ankle surgery, deformity, or injury on the unaffected side which would affect gait, WB dorsiflexion or balance
. Unable to attend follow-up visits
. Any cognitive impairments which would prevents patients from being able to complete or understand questionnaires
. Have received any previous manual therapy for their current ankle and/or hindfoot fracture
. Have a known non/malunion
. Have additional fractures of the spine, hip, or knee that would likely affect their weight bearing or gait