Effects of Lower Limbs Symmetrical Loading on Risk of Fall

October 4, 2023 updated by: Burcu Özdemir Kocabey, Bahçeşehir University

Does Symmetrical Lower Limb Loads Distribution Effects Balance and Risk of Fall After Total Hip Arthroplasty?

Objective: To assess the impact of total hip arthroplasty (THA) on functional outcomes and fall risk in patients with hip osteoarthritis. The objective was to investigate the effectiveness of physical therapy in postoperative rehabilitation and identify fall risk factors to guide fall prevention strategies after THA.

Methods: A non-randomized, interventional clinical trial was conducted with 30 patients scheduled for THA. Functional outcomes were evaluated using the Harris Hip Score (HHS), 40-meter fast-paced walk test (40mFPWT), 30-Second Chair Test, and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Balance and fall risk were assessed using the Single-Leg Standing Test and a posturography device (TETRAX). The Nottingham Health Profile (NHP) was used to measure subjective health status and quality of life. Assessments were performed preoperatively, at 6 weeks postoperatively, and at 3 months postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical and radiographic evidence of unilateral hip osteoarthritis
  • Volunteering to participate in the study

Exclusion Criteria:

  • History of neurologic disorders affecting postural control (e.g., Parkinson disease)
  • Have other problems that affect balance, such as vertigo
  • Undergoing revision hip surgery
  • Osteoarthritis in the other lower extremity joints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
30 patients who underwent total hip arthroplasty surgery took part in the experimental group.
Other: postoperative rehabilitation
30 patients took postoperative rehabilitation after total hip arthroplasty surgery, 3 times a week, for 6 weeks. They took conventional rehabilitation (hip range of motion exercises, progressive strengthening exercises for hip and knee muscles, balance and proprioceptive exercises and gait training).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score (HHS)
Time Frame: preoperative, postoperative 6 weeks and 3 months
min-max (0-100) Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
preoperative, postoperative 6 weeks and 3 months
40-meter fast-paced walk test
Time Frame: preoperative, postoperative 6 weeks and 3 months
preoperative, postoperative 6 weeks and 3 months
30-Second Chair Test
Time Frame: preoperative, postoperative 6 weeks and 3 months
preoperative, postoperative 6 weeks and 3 months
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: preoperative, postoperative 6 weeks and 3 months
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain, Stiffness, Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
preoperative, postoperative 6 weeks and 3 months
Static balance and fall risk
Time Frame: preoperative, postoperative 6 weeks and 3 months
It was assessed with Posturography device (TETRAX)
preoperative, postoperative 6 weeks and 3 months
Single-Leg Standing Test
Time Frame: preoperative, postoperative 6 weeks and 3 months
preoperative, postoperative 6 weeks and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Nottingham Health Profile (NHP)
Time Frame: preoperative, postoperative 6 weeks and 3 months

The NHP is composed of 38 items divided into six domains:

  1. Sleep
  2. Mobility
  3. Energy
  4. Pain
  5. Emotional reactions
  6. Social isolation Items use a Yes/No answer format. Each item is weighted. NHP scores are calculated by averaging domain scores. Total scores range from 0 (no perceived distress) to 100 (maximum perceived distress).
preoperative, postoperative 6 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Principal Investigator: Selvi Yüce, PhD(c), Acibadem Maslak Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2015

Primary Completion (Actual)

June 5, 2016

Study Completion (Actual)

July 22, 2016

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AcibademHospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe