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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yvonne Golightly PT, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01894100
First received: July 2, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Leg Length Inequality
Osteoarthritis, Knee
Osteoarthritis, Hip
Device: Shoe lift correction for leg length inequality

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining and Correcting Limb Length Inequality in Adults With Knee or Hip Symptoms

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in pain intensity [ Time Frame: Baseline and 3 and 6 months after initiating intervention ] [ Designated as safety issue: No ]
    Western Ontario and McMasters Universities Osteoarthritis Index pain subscale


Secondary Outcome Measures:
  • Change in lower extremity physical function [ Time Frame: Baseline and 3 and 6 months post intervention ] [ Designated as safety issue: No ]

    For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale

    For performance based lower extremity physical function: Short Physical Performance Battery



Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delayed Intervention Group
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.
Device: Shoe lift correction for leg length inequality
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.
Experimental: Immediate Intervention Group
At baseline, participants in this group will begin shoe lift correction for leg length inequality.
Device: Shoe lift correction for leg length inequality
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894100

Locations
United States, North Carolina
UNC-CH Thurston Arthritis Research Center
Smithfield, North Carolina, United States, 27577
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Yvonne M Golightly, PT, MS, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Yvonne Golightly PT, PhD, Research Assistant Professor, Epidemiology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01894100     History of Changes
Other Study ID Numbers: 13-0807
Study First Received: July 2, 2013
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Leg Length Inequality
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases, Developmental
Bone Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014