Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00888498
Status:
SUSPENDED
Last Update Posted:
2015-07-02
First Post:
2009-04-24
Brief Title:
Ankle Manual Therapy for Ankle Sprains
Sponsor:
University of the Pacific
Organization:
University of the Pacific
Study Overview
Official Title:
Ankle Manual Therapy for Individuals With Post-Acute Ankle Sprains A Randomized Placebo-Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMT
Brief Summary:
The purpose of this study is to determine the effect of using ankle manual therapy procedures on clinical outcomes in individuals with post-acute ankle sprains
Detailed Description:
Ankle sprains can cause ankle joint stiffness Ankle joint stiffness may be a cause of pain disability and repeated sprains Physical therapists use many ways to treat ankle joints that do not move well One way takes 1-2 seconds Another way may take up to 1 minute Both kinds of stretches seem to improve ankle flexibility However we do not know how well they work to improve pain and disability in individuals following ankle sprains The purpose of this research is to find out which physical therapy treatments work best for people with ankle sprains To start the study subjects will be asked to fill out some forms that ask about their ankle problem Subjects will receive an examination by a physical therapist that includes gentle movements of the feet and legs to test their flexibility strength and balance Subjects will then be assigned to 1 of 3 treatments to be provided by a separate physical therapist They will not get to choose their group All 3 groups will receive ankle stretching by the physical therapist The groups will differ in how much and how fast the stretch will be The first group will have an ankle stretch that lasts 1-2 seconds The second group will have a stretch that lasts 1 minute The third group will have their foot held without any stretching After stretching all subjects will receive the same kind of exercise program Study-related treatment will last 5 sessions over 4 weeks with 2 sessions for stretching within the 1st week and 1 session per week for the 3 following weeks for the exercise program After 1 week and 4 weeks subjects will fill out the same forms as at the initial examination The treatment part of the study will then be finished After 6 months 1 year and 2 years from enrollment in the study subjects be asked to fill out many of the same forms that ask about their ankle problem We think subjects that get a stretch will have a better outcome than subjects that get ankle holding To test our idea we will compare how subjects in each group tell us they are doing with their ankle problem on the Foot and Ankle Ability Measure at 1 week 4 weeks 6 months 1 year and 2 years following entry into the study Since the way a person thinks and feels about their injury may have something to do with how much they improve during physical therapy we will also measure these factors to find out if they affect the results of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None