- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343195
Balance and Leg Function After Hip Replacement
Effect of Task-Specific Exercise on Balance and Leg Function in Patients After Total Hip Replacement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kaunas, Lithuania
- Lithuanian Sports University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI < 40;
- Hip coxarthrosis;
- Hip total replacement;
- Posterior incision;
- Surgery performed no more than 1 week ago;
- Ability to comprehend and execute the tasks.
Exclusion Criteria:
- Revision surgery;
- Surgery intervention for other reasons (fracture, arthritis);
- Severe cardiovascular disease;
- Vestibular disorders;
- Vision disorders;
- Proprioception disorders;
- Neurological disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Conventional physiotherapy was applied 5 days/ week, 30 min session, in total 18 days. Exercise program:
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Control intervention: conventional physiotherapy after hip replacement
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Experimental: Task oriented exercise group
Task oriented exercise program was applied 5 days/ week, 30 min session, in total 18 days. Exercise program included:
Task oriented exercise included:
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Task-oriented exercise program for patients after total hip replacement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Pain at 18 days
Time Frame: Baseline and after 18 days
|
was evaluated using the Visual Analogue Pain Scale (VAS).
Participants were asked to report "current" pain intensity.
A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
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Baseline and after 18 days
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Change from baseline Hip range of motions at 18 days
Time Frame: Baseline and after 18 days
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Using goniometer the range of hip motions were evaluated: flexion, extension, abduction.
Each motion was measured three times and averaged value was used.
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Baseline and after 18 days
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Change from baseline Hip Muscle Strength at 18 days
Time Frame: Baseline and after 18 days
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The muscle strength of hip flexion, extension, and abduction was evaluated using manual muscle testing technique (Oxford 5 point scale).
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Baseline and after 18 days
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Change from baseline Leg Function at 18 days
Time Frame: Baseline and after 18 days
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To evaluate the function of leg after hip replacement surgery the modified Harris Hip Score (mHHS) was used. MHHS is reliable and valid tool to evaluate leg function after hip replacement and to monitor the leg function during recovery. The questionnaire was completed by a physiotherapist together with the patient. This questionnaire consists of 8 questions / topics, where each answer has a score:
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Baseline and after 18 days
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Change from baseline Dynamic Balance at 18 days
Time Frame: Baseline and after 18 days
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Dynamic Balance was assessed using the Berg Balance Scale (BBS).
This scale is used to assess the subjects' imbalance in 14 different tasks, where each task is scored on a scale from 0 (does not perform at all) to 4 (performs excellent).
The higher the score, the better the balance, with a maximum score of 56.
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Baseline and after 18 days
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Change from baseline Static Balance at 18 days
Time Frame: Baseline and after 18 days
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Static Balance was assessed using the "Abili balance analyzer system".
Abili balance analyzer is a platform that can be adapted for both patient testing and training.
The Abili analyzer system consists of two parts: the Abili analyzer platform and the Balance trainer app.
The Abili analyzer platform plate moves in a horizontal plane, making it safe to use for patients of all capacities.
Thus, using this balance platform, three levels of difficulty can be selected: light, medium and advanced, as well as the handles are adjustable according to the patient's height.
After three tests, the gadget calculates a total stability index.
The lower the number, the better the stability and the lower the fluctuation.
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Baseline and after 18 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LithuanianSportsU-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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