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Balance and Leg Function After Hip Replacement

Primary Purpose

Hip Injuries, Coxarthrosis, Hip Replacement

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Task-oriented exercise
Control
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries focused on measuring balance, hip function, hip replacement, elderly, physical functioning

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lithuanian Sports University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Task oriented exercise group

Arm Description

Conventional physiotherapy was applied 5 days/ week, 30 min session, in total 18 days. Exercise program: 1-2 week: 20 min. of active exercise in lying position (e.g.: hip flexion, extension, abduction) with the goal to improve hip range of motions, strengthen muscles. Various equipment was used (slippery base, elastic bands, foam roller, gymnastic ball etc.). + gait training exercise within the bars (10 min); 3 week: 20 min. of active exercise in lying position + stationary bicycle / treadmill (10 min).

Task oriented exercise program was applied 5 days/ week, 30 min session, in total 18 days. Exercise program included: 1 week: active exercise in lying position (15 min) + task-oriented exercise (15 min); 2 week: active exercise in lying position (10 min) + task-oriented exercise (20 min); 3 week: stationary bicycle / treadmill (10 min) + task-oriented exercise (20 min). Task oriented exercise included: walking backwards, sideways, high kneels (on the instable bases); walking with alternate speed (physiotherapist give the instruction when to walk faster / slower); Sit and stand from the chair (standing up to reach for the ball held by the physiotherapist); step onto the step (after stepping to reach the ball held by the physiotherapist); walk with the obstacles (obstacle course); Catch and throw the ball while standing on an unstable base.

Outcomes

Primary Outcome Measures

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).
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.
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2022
Last Updated
April 23, 2022
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT05343195
Brief Title
Balance and Leg Function After Hip Replacement
Official Title
Effect of Task-Specific Exercise on Balance and Leg Function in Patients After Total Hip Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries, Coxarthrosis, Hip Replacement
Keywords
balance, hip function, hip replacement, elderly, physical functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy was applied 5 days/ week, 30 min session, in total 18 days. Exercise program: 1-2 week: 20 min. of active exercise in lying position (e.g.: hip flexion, extension, abduction) with the goal to improve hip range of motions, strengthen muscles. Various equipment was used (slippery base, elastic bands, foam roller, gymnastic ball etc.). + gait training exercise within the bars (10 min); 3 week: 20 min. of active exercise in lying position + stationary bicycle / treadmill (10 min).
Arm Title
Task oriented exercise group
Arm Type
Experimental
Arm Description
Task oriented exercise program was applied 5 days/ week, 30 min session, in total 18 days. Exercise program included: 1 week: active exercise in lying position (15 min) + task-oriented exercise (15 min); 2 week: active exercise in lying position (10 min) + task-oriented exercise (20 min); 3 week: stationary bicycle / treadmill (10 min) + task-oriented exercise (20 min). Task oriented exercise included: walking backwards, sideways, high kneels (on the instable bases); walking with alternate speed (physiotherapist give the instruction when to walk faster / slower); Sit and stand from the chair (standing up to reach for the ball held by the physiotherapist); step onto the step (after stepping to reach the ball held by the physiotherapist); walk with the obstacles (obstacle course); Catch and throw the ball while standing on an unstable base.
Intervention Type
Other
Intervention Name(s)
Task-oriented exercise
Intervention Description
Task-oriented exercise program for patients after total hip replacement.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control intervention: conventional physiotherapy after hip replacement
Primary Outcome Measure Information:
Title
Change from baseline Pain at 18 days
Description
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).
Time Frame
Baseline and after 18 days
Title
Change from baseline Hip range of motions at 18 days
Description
Using goniometer the range of hip motions were evaluated: flexion, extension, abduction. Each motion was measured three times and averaged value was used.
Time Frame
Baseline and after 18 days
Title
Change from baseline Hip Muscle Strength at 18 days
Description
The muscle strength of hip flexion, extension, and abduction was evaluated using manual muscle testing technique (Oxford 5 point scale).
Time Frame
Baseline and after 18 days
Title
Change from baseline Leg Function at 18 days
Description
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.
Time Frame
Baseline and after 18 days
Title
Change from baseline Dynamic Balance at 18 days
Description
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.
Time Frame
Baseline and after 18 days
Title
Change from baseline Static Balance at 18 days
Description
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.
Time Frame
Baseline and after 18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance and Leg Function After Hip Replacement

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