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

NCT01894100 | Completed Results

• 1 other identifier: 13-0807
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Leg Length Inequality; Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 3 months after initiating intervention

Secondary Outcomes (1)

• Change in Lower Extremity Physical Function

  Baseline and 3 months post intervention

Study Arms (2)

Delayed Intervention Group

OTHER

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

Immediate Intervention Group

EXPERIMENTAL

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

Device: Shoe lift correction for leg length inequality

Interventions

Shoe lift correction for leg length inequality DEVICE

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.

Delayed Intervention Group; Immediate Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC-CH Thurston Arthritis Research Center

Smithfield, North Carolina, 27577, United States

Location

MeSH Terms

Conditions

Leg Length Inequality; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Yvonne M. Golightly, PT, PhD
• Organization: University of North Carolina at Chapel Hill

golight@email.unc.edu

919-966-0566

Study Officials

• Yvonne M Golightly, PT, MS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor, Epidemiology

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 9, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 14, 2017
• Results First Posted: October 26, 2016

Record last verified: 2017-05

Locations

US (1)