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OpenTrials
Completed

NCT Number: NCT06077825

Effects of Lower Limbs Symmetrical Loading on Risk of Fall

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.

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Key information

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postoperative rehabilitation

Other

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).

Primary outcomes

  1. 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.

  2. 40-meter fast-paced walk test

    Time frame: preoperative, postoperative 6 weeks and 3 months

  3. 30-Second Chair Test

    Time frame: preoperative, postoperative 6 weeks and 3 months

  4. 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.

  5. Static balance and fall risk

    Time frame: preoperative, postoperative 6 weeks and 3 months

    It was assessed with Posturography device (TETRAX)

  6. Single-Leg Standing Test

    Time frame: preoperative, postoperative 6 weeks and 3 months

Secondary outcomes

  1. 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:

    • 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).

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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