Balance and Leg Function After Hip Replacement

NCT05343195 | Completed

• 1 other identifier: LithuanianSportsU-9
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Injuries; Coxarthrosis; Hip Replacement

Keywords

balance; hip function; hip replacement; elderly; physical functioning

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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).

Other: Control

Task oriented exercise group

EXPERIMENTAL

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.

Other: Task-oriented exercise

Interventions

Task-oriented exercise OTHER

Task-oriented exercise program for patients after total hip replacement.

Task oriented exercise group

Control OTHER

Control intervention: conventional physiotherapy after hip replacement

Control group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \< 40;
• Hip coxarthrosis;
• Hip total replacement;
• Posterior incision;
• Surgery performed no more than 1 week ago;
• Ability to comprehend and execute the tasks.

You may not qualify if:

• Revision surgery;
• Surgery intervention for other reasons (fracture, arthritis);
• Severe cardiovascular disease;
• Vestibular disorders;
• Vision disorders;
• Proprioception disorders;
• Neurological disorders.

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Hip Injuries; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: March 15, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)