Effects of Lower Limbs Symmetrical Loading on Risk of Fall

Sponsor

Bahçeşehir University (Other)

Overall Status

Completed

CT.gov ID

NCT06077825

Collaborator

(none)

Enrollment

Arm

12.3

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Replacement	Other: postoperative rehabilitation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2015

Actual Primary Completion Date :

Jun 5, 2016

Actual Study Completion Date :

Jul 22, 2016

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Harris Hip Score (HHS) [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.
40-meter fast-paced walk test [preoperative, postoperative 6 weeks and 3 months]
30-Second Chair Test [preoperative, postoperative 6 weeks and 3 months]
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) [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.
Static balance and fall risk [preoperative, postoperative 6 weeks and 3 months]
It was assessed with Posturography device (TETRAX)
Single-Leg Standing Test [preoperative, postoperative 6 weeks and 3 months]

Secondary Outcome Measures

The Nottingham Health Profile (NHP) [preoperative, postoperative 6 weeks and 3 months]
The NHP is composed of 38 items divided into six domains: Sleep Mobility Energy Pain Emotional reactions 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bahçeşehir University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Burcu Özdemir Kocabey, PhD, Bahçeşehir University

ClinicalTrials.gov Identifier:

NCT06077825

Other Study ID Numbers:

AcibademHospital

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Burcu Özdemir Kocabey, PhD, Bahçeşehir University

total hip arthroplasty

static balance

postoperative rehabilitation

Study Results

No Results Posted as of Oct 11, 2023