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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01894100
First Posted: July 9, 2013
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yvonne Golightly PT, PhD, University of North Carolina, Chapel Hill
  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
Intervention Model: Parallel Assignment
Masking: None (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 Yvonne Golightly PT, PhD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Pain Intensity [ Time Frame: Baseline and 3 months after initiating intervention ]
    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 [ Time Frame: Baseline and 3 months post intervention ]
    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).


Enrollment: 46
Study Start Date: July 2013
Study Completion Date: March 2015
Primary Completion Date: March 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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 2, 2013
First Posted: July 9, 2013
Results First Submitted: September 2, 2016
Results First Posted: October 26, 2016
Last Update Posted: June 14, 2017
Last Verified: May 2017

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