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Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms

Primary Purpose

Leg Length Inequality, Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoe lift correction for leg length inequality
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Length Inequality

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • participants from the Johnston County Osteoarthritis Project who have been previously identified to have a LLI and knee or hip symptoms

Exclusion Criteria:

  • hospitalized for stroke, myocardial infarction, coronary artery revascularization, or diagnosis of metastatic cancer in the past 3 months
  • terminal illness
  • rheumatoid arthritis, severe fibromyalgia, or other systemic rheumatic disease

Sites / Locations

  • UNC-CH Thurston Arthritis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Delayed Intervention Group

Immediate Intervention Group

Arm Description

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

Outcomes

Primary Outcome Measures

Change in Pain Intensity
Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).

Secondary Outcome Measures

Change in Lower Extremity Physical Function
For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).

Full Information

First Posted
July 2, 2013
Last Updated
May 16, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01894100
Brief Title
Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms
Official Title
Defining and Correcting Limb Length Inequality in Adults With Knee or Hip Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Limb length inequality is when a person has one leg that is longer than the other. This research will look at correcting limb length inequality in adults with knee or hip symptoms. This study will examine whether ways of measuring leg length inequality in the clinic are valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is related to leg length inequality, and determine whether shoe lifts are a helpful treatment for leg length inequality and knee/hip symptoms.
Detailed Description
The purpose of this study is to examine the optimal clinical assessment method(s) for leg length inequality (LLI), determine if there is an association between foot posture (flat foot, normal, and high arch) and LLI, and gather preliminary data on lift therapy as a treatment for LLI and knee/hip symptoms. The specific aims of the project are as follows: Specific Aim 1: Determine the validity and reliability of 4 clinical methods for assessing LLI. Specific Aim 2: Determine differences in static and dynamic foot postures between longer and shorter limbs. Specific Aim 3: Assess the feasibility of conducting a specific lift therapy intervention among individuals with a LLI and knee or hip pain, refining procedures as needed. Public Health Impact: Results from the proposed research will be used to: 1) improve diagnosis of LLI by providing evidence on the various assessment methods for the clinicians who most frequently use clinical methods (i.e., physical therapists, chiropractors, podiatrists, and primary care physicians), and 2) develop and test new non-pharmacologic/non-invasive intervention strategies aimed at reducing pain and improving function in individuals with osteoarthritis and LLI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Inequality, Osteoarthritis, Knee, Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Intervention Group
Arm Type
Other
Arm Description
This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.
Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Intervention Type
Device
Intervention Name(s)
Shoe lift correction for leg length inequality
Intervention Description
Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height.
Primary Outcome Measure Information:
Title
Change in Pain Intensity
Description
Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).
Time Frame
Baseline and 3 months after initiating intervention
Secondary Outcome Measure Information:
Title
Change in Lower Extremity Physical Function
Description
For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).
Time Frame
Baseline and 3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: participants from the Johnston County Osteoarthritis Project who have been previously identified to have a LLI and knee or hip symptoms Exclusion Criteria: hospitalized for stroke, myocardial infarction, coronary artery revascularization, or diagnosis of metastatic cancer in the past 3 months terminal illness rheumatoid arthritis, severe fibromyalgia, or other systemic rheumatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne M Golightly, PT, MS, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-CH Thurston Arthritis Research Center
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States

12. IPD Sharing Statement

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Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms

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