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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05343195
Other study ID # LithuanianSportsU-9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date February 1, 2022

Study information

Verified date April 2022
Source Lithuanian Sports University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Task-oriented leg exercise are commonly used after joint surgeries in various hip pathologies. Based on this theory, it was hypothesized that task-oriented exercise without conventional physiotherapy can have better result in recovery of balance and leg function than with a conventional post-hip physiotherapy program after hip replacement surgery. The aim of the study was to determine the effect of task-oriented exercise on balance and leg function after total hip replacement.


Description:

Study included 40 subjects. All subjects were randomly divided into control and intervention groups. VAS scale was used to assess the pain, hip range of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, leg function was evaluated with modified Harris hip scale, Abili balance analyzer was used to assess static balance and Berg balance scale was used to measure dynamic balance. Intervention duration was 18 days.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
Task-oriented exercise
Task-oriented exercise program for patients after total hip replacement.
Control
Control intervention: conventional physiotherapy after hip replacement

Locations

Country Name City State
Lithuania Lithuanian Sports University Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Pain at 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). Baseline and after 18 days
Primary Change from baseline Hip range of motions at 18 days Using goniometer the range of hip motions were evaluated: flexion, extension, abduction. Each motion was measured three times and averaged value was used. Baseline and after 18 days
Primary Change from baseline Hip Muscle Strength at 18 days The muscle strength of hip flexion, extension, and abduction was evaluated using manual muscle testing technique (Oxford 5 point scale). Baseline and after 18 days
Primary Change from baseline Leg Function at 18 days 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:
Pain description (maximum 44 points);
Limping (max 11 points);
Assistive devices (max 11 points);
Walking distance (max 11 points);
Stair climbing (max 4 points);
Putting on shoes/socks (max 4 points);
Sitting (max 5 points);
Using public transport (1 point). The higher the score, the better the leg function. The maximum number of points is 91.
Baseline and after 18 days
Primary Change from baseline Dynamic Balance at 18 days 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. Baseline and after 18 days
Primary Change from baseline Static Balance at 18 days 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. Baseline and after 18 days
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