Hip InjuriesNCT05343195
Balance and Leg Function After Hip Replacement
A study testing Task-oriented exercise in people with Hip Injuries and Coxarthrosis, run by Lithuanian Sports University at 1 site in Lithuania.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Hip Injuries, Coxarthrosis, Hip Replacement
- What is being tested?
- Task-oriented exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Mar 2021to 1 Feb 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI < 40;
- Hip coxarthrosis;
- Hip total replacement;
- Posterior incision;
- Surgery performed no more than 1 week ago;
- Ability to comprehend and execute the tasks.
Who cannot join
- Revision surgery;
- Surgery intervention for other reasons (fracture, arthritis);
- Severe cardiovascular disease;
- Vestibular disorders;
- Vision disorders;
- Proprioception disorders;
- Neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Task-Specific Exercise on Balance and Leg Function in Patients After Total Hip Replacement
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.
Read the 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.
- Conditions
- Hip Injuries, Coxarthrosis, Hip Replacement
- Being tested
- Task-oriented exercise, Control
- Keywords
- balance, hip function, hip replacement, elderly, physical functioning
- Medical subject headings
- Hip Injuries, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented exerciseOther
Task-oriented exercise program for patients after total hip replacement.
ControlOther
Control intervention: conventional physiotherapy after hip replacement
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Task-oriented exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Mar 2021
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343195
- Sponsor's protocol ID
- LithuanianSportsU-9
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task-Specific Exercise on Balance and Leg Function in Patients After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05343195
- Acronym / sponsor ID
- LithuanianSportsU-9
- Conditions
- Hip Injuries, Coxarthrosis, Hip Replacement
- Keywords
- balance, hip function, hip replacement, elderly, physical functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 25 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ControlConventional 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 group | Experimental | Other: Task-oriented exerciseTask 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI < 40;
- Hip coxarthrosis;
- Hip total replacement;
- Posterior incision;
- Surgery performed no more than 1 week ago;
Key exclusion criteria (7 listed)
- Revision surgery;
- Surgery intervention for other reasons (fracture, arthritis);
- Severe cardiovascular disease;
- Vestibular disorders;
- Vision disorders;
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 |
|---|---|---|
| Task-oriented exerciseTask-oriented exercise program for patients after total hip replacement. | Other | Task oriented exercise group |
| ControlControl intervention: conventional physiotherapy after hip replacement | Other | Control group |
Primary outcome
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).
Change from baseline Hip range of motions at 18 days
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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
Time frame: Baseline and after 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.
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 26 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented exercise in people with Hip Injuries and Coxarthrosis, run by Lithuanian Sports University at 1 site in Lithuania.
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 6 inclusion and 7 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline Pain at 18 days (time frame: Baseline and after 18 days). 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 26 Apr 2022.