Total Hip ReplacementNCT06077825
Effects of Lower Limbs Symmetrical Loading on Risk of Fall
A study testing postoperative rehabilitation in people with Total Hip Replacement, run by Bahçeşehir University.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- postoperative rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2015to 22 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiographic evidence of unilateral hip osteoarthritis
- Volunteering to participate in the study
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Total Hip Replacement
- Being tested
- postoperative rehabilitation
- Keywords
- total hip arthroplasty, static balance, postoperative rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative rehabilitationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 30 patients who underwent total hip arthroplasty surgery took part in the experimental group. Receives: Other: postoperative rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
min-max (0-100) Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: preoperative, postoperative 6 weeks and 3 months
40-meter fast-paced walk test
Measured: preoperative, postoperative 6 weeks and 3 months
30-Second Chair Test
Measured: preoperative, postoperative 6 weeks and 3 months
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
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.
Measured: preoperative, postoperative 6 weeks and 3 months
Static balance and fall risk
It was assessed with Posturography device (TETRAX)
Measured: preoperative, postoperative 6 weeks and 3 months
Single-Leg Standing Test
Measured: preoperative, postoperative 6 weeks and 3 months
Secondary outcomes (1)
The Nottingham Health Profile (NHP)
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).
Measured: preoperative, postoperative 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Jul 2015
- Primary completion5 Jun 2016
- Study completion22 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Özdemir Kocabey, Bahçeşehir University
- Investigators
- Selvi Yüce, PhD(c), Principal investigator, Acibadem Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077825
- Sponsor's protocol ID
- AcibademHospital
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Symmetrical Lower Limb Loads Distribution Effects Balance and Risk of Fall After Total Hip Arthroplasty?
- ClinicalTrials.gov ID
- NCT06077825
- Acronym / sponsor ID
- AcibademHospital
- Conditions
- Total Hip Replacement
- Keywords
- total hip arthroplasty, static balance, postoperative rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 22 Jul 2016 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: postoperative rehabilitation30 patients who underwent total hip arthroplasty surgery took part in the experimental group. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and radiographic evidence of unilateral hip osteoarthritis
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative rehabilitation30 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). | Other | experimental group |
Primary outcome
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.
40-meter fast-paced walk test
Time frame: preoperative, postoperative 6 weeks and 3 months
30-Second Chair Test
Time frame: 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.
Static balance and fall risk
Time frame: preoperative, postoperative 6 weeks and 3 months
It was assessed with Posturography device (TETRAX)
Single-Leg Standing Test
Time frame: preoperative, postoperative 6 weeks and 3 months
1 secondary outcome
The Nottingham Health Profile (NHP)
Time frame: preoperative, postoperative 6 weeks and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selvi Yüce, PhD(c) principal investigator
Acibadem Maslak Hospital
Questions about this trial
What is this clinical trial studying?
A study testing postoperative rehabilitation in people with Total Hip Replacement, run by Bahçeşehir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: preoperative, postoperative 6 weeks and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.