Osteoarthritis, HipNCT02451085
The Effect of a Telerehabilitaion Program on Gait and Balance in Patients After Hip Surgery
A study testing training with video therapy and conventional exercise in people with Osteoarthritis, Hip and Hip Injuries, run by Reuth Rehabilitation Hospital at 1 site in Israel.
Trial summary
The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, Hip, Hip Injuries
- What is being tested?
- training with video therapy and conventional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to 10 Aug 2017
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One to three months after hip surgery
- Age 50-85
Who cannot join
- Individuals with central neurological disability
- Dependent individuals in passing from bed to wheelchair
- Significant cognitive disability according to the attendant physician
- Individuals with vascular-based pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Telerehabilitaion Program on Gait and Balance in Patients After Hip Surgery.
The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients.
Read the detailed description
Osteoarthritis is the main and most common reason for replacing hip joint and in forecast for 2020s this will be the fourth reason that causes disabilities throughout the world. Osteoarthritis causes not only physical limitation but also damage to the quality of life. Pain and functional limitation appear among about 10% of men and 18% of women over the age of 60. Pain and limitation in range of movement, functional decrease in daily functioning such as walking distance and endurance, difficulty in climbing up and down stairs are typical signs among those patients before surgery and treatment.
Other physical defects following hip replacement surgery last for over a year and they include a decrease in muscle strength round the operated hip, a defect in keeping balance in the operated leg and a functional decrease that includes decrease in walking speed, damage in the ability of climbing up and down stairs and difficulty in standing up.
Physical rehabilitation has importance among patients after hip joint surgery. Rehabilitation begins on the first stage at the rehabilitation hospital and continues after discharge at the community, at home or at the clinic. Often, the need for a continuing rehabilitation treatment after discharge exceeds the treatment provided actually by healthcare in Israel because of various reasons e.g. residence in remote areas, loads of patients who need treatment and high costs of manpower and reaching the treatments.
Remote Therapy is an alternative means to the present therapy in clinics which is provided at the patient's home and thus solving these problems. Remote Therapy employs technological communication and thus enables the patient to continue the rehabilitation process independently with no need for reaching the clinic which makes it easier for the patient and saves economic costs for the financial agent.
The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients
- Conditions
- Osteoarthritis, Hip, Hip Injuries
- Being tested
- training with video therapy, conventional exercise
- Keywords
- hip, surgery, Replacement
- Medical subject headings
- Osteoarthritis, Hip, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training with video therapyBehavioural
training with video therapy
conventional exerciseBehavioural
training in conventional way
| Study group | Role | What they receive |
|---|---|---|
| remote rehabilitation group | Experimental | 'training with video therapy' a domestic exercise plan through remote rehabilitation system based on short film. (http://videotherapy.co/vt/home.php), the plan will include installation of exercises adapted according to the physical condition of the patient. The content of each exercise is dynamic and variable. The difference between each exercise and the other depends on the feedback that the patient fills at the end of each exercise and sends to the therapist. Before each exercise, it is shown with explanations about the importance of performing it the way of performing. Furthermore, during the training, the patient listens to vocal explanation about the quality and importance of performing the exercise, and a vocal counting is heard and then a positive feedback is given. Receives: Behavioral: training with video therapy |
| conventional exercise group | Other | will receive instruction for self-training as accepted today through exercise sheet. The exercises will be suited to the ones provided to the patients in the intervention group. Moreover, a follow-up sheet will be given to the patients to fill in order to receive a feedback at the end of experiment. The training duration will be identical in both groups and will last for 30-45 minutes, three times a week. Receives: Behavioral: conventional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAITMAT
is an electronic path used to measure the time (timing) and space via pressure sensors placed on a track. The purpose of the system is to measure the events that occur during movement, data on time and space is measured and walking speed
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
SMART STEP
is an instrument which provides feedback during walking about the amount of burden that the patient places on his leg. A feedback about placing the burden on the whole foot, toes or on the heel is possible. Investigators will set the minimal and maximal weight that we want the patient to reach while stepping. When the patient reaches the minimal weight, he will hear a single pip and when he reaches the maximal weight or more, he will hear two pips. In other words, this instrument gives us an indication for the patient's carrying of the weight- how much weight he placed on the leg while walking on each area and indication for the duration of the foot placed on the ground and in the air
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
BBS (Berg Balance Scale)
the test includes 14 static and dynamic tasks for keeping balance. Each task receives a score from 0 to 4 points- according to the quality of task and performance time, maximal score of 56 points. Instructions regarding performing each task separately and the score of each task appear in the test form.
The low performance in each task is considered in the score. In most tasks the patient is asked to keep a specific pose for a while. The score must be decreased if the patient does not meet the requirements of wished time or distance or if he gets external support or assisted by the tester.
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
Secondary outcomes (4)
TUGT (Times Up And Go):
A balance test which is measures by time, the ability of standing up from sitting position, walking for three meters, turning around and sitting down. This test examines the ability to integrate balance and movement including establishing movement, initiation, performing and completing a set of attached movements that we encounter in daily functioning.
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
THE FIVE SIT-TO-STAND TEST
a physical test that integrates dynamic balance test. In this test the patient is asked to stand up and sit down five times continuously as quickly as possible on a standard chair and the tester measures the time.
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
MLEFS- LOWER EXTREMITY FUNCTIONAL SCALE
subjective questionnaire that will assess their independency degree according to the subjective report of each patient. Result of 80/80 indicates full independency while 0/80 indicates external difficulty or disability in functioning
Measured: Base line; change after 6 weeks treatment; and change after 10 weeks
responsiveness to the treatment
At the end of each week a form is delivered to the patients in order to examine the responsiveness to the treatment; the form includes two questions regarding the performance of exercise. At the beginning of the experiment each patient receives a form and at the end of each week they must answer both questions and send the answers via SMS to the secondary investigator, or via fax.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJul 2015
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Reuth Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Video Therapy Ltd.
- Responsible party
- Sponsor
- Investigators
- Jean-Jeaques Vatine, Prof, Principal investigator, Reuth Rehabilitation HospitalAlon Kalron, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451085
- Sponsor's protocol ID
- 2015-2
- Status last verified
- Sep 2019
- First submitted
- 20 Apr 2015
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Telerehabilitaion Program on Gait and Balance in Patients After Hip Surgery.
- ClinicalTrials.gov ID
- NCT02451085
- Acronym / sponsor ID
- 2015-2
- Conditions
- Osteoarthritis, Hip, Hip Injuries
- Keywords
- hip, surgery, Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Reuth Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Video Therapy Ltd.
- Study start
- Jul 2015
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- 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.
The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients.
Detailed description
Osteoarthritis is the main and most common reason for replacing hip joint and in forecast for 2020s this will be the fourth reason that causes disabilities throughout the world. Osteoarthritis causes not only physical limitation but also damage to the quality of life. Pain and functional limitation appear among about 10% of men and 18% of women over the age of 60. Pain and limitation in range of movement, functional decrease in daily functioning such as walking distance and endurance, difficulty in climbing up and down stairs are typical signs among those patients before surgery and treatment.
Other physical defects following hip replacement surgery last for over a year and they include a decrease in muscle strength round the operated hip, a defect in keeping balance in the operated leg and a functional decrease that includes decrease in walking speed, damage in the ability of climbing up and down stairs and difficulty in standing up.
Physical rehabilitation has importance among patients after hip joint surgery. Rehabilitation begins on the first stage at the rehabilitation hospital and continues after discharge at the community, at home or at the clinic. Often, the need for a continuing rehabilitation treatment after discharge exceeds the treatment provided actually by healthcare in Israel because of various reasons e.g. residence in remote areas, loads of patients who need treatment and high costs of manpower and reaching the treatments.
Remote Therapy is an alternative means to the present therapy in clinics which is provided at the patient's home and thus solving these problems. Remote Therapy employs technological communication and thus enables the patient to continue the rehabilitation process independently with no need for reaching the clinic which makes it easier for the patient and saves economic costs for the financial agent.
The purpose of the present study is to examine whether an intervention plan based on exercise through remote rehabilitation system leads to improvement in characteristics of walking and balance among patients after hip replacement surgery compared to the current conventional way of exercise among these patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remote rehabilitation group | Experimental | Behavioral: training with video therapy'training with video therapy' a domestic exercise plan through remote rehabilitation system based on short film. (http://videotherapy.co/vt/home.php), the plan will include installation of exercises adapted according to the physical condition of the patient. The content of each exercise is dynamic and variable. The difference between each exercise and the other depends on the feedback that the patient fills at the end of each exercise and sends to the therapist. Before each exercise, it is shown with explanations about the importance of performing it the way of performing. Furthermore, during the training, the patient listens to vocal explanation about the quality and importance of performing the exercise, and a vocal counting is heard and then a positive feedback is given. |
| conventional exercise group | Other | Behavioral: conventional exercisewill receive instruction for self-training as accepted today through exercise sheet. The exercises will be suited to the ones provided to the patients in the intervention group. Moreover, a follow-up sheet will be given to the patients to fill in order to receive a feedback at the end of experiment. The training duration will be identical in both groups and will last for 30-45 minutes, three times a week. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One to three months after hip surgery
- Age 50-85
Key exclusion criteria (4 listed)
- Individuals with central neurological disability
- Dependent individuals in passing from bed to wheelchair
- Significant cognitive disability according to the attendant physician
- Individuals with vascular-based pathologies
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 |
|---|---|---|
| training with video therapytraining with video therapy | Behavioural | remote rehabilitation group |
| conventional exercisetraining in conventional way | Behavioural | conventional exercise group |
Primary outcome
GAITMAT
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
is an electronic path used to measure the time (timing) and space via pressure sensors placed on a track. The purpose of the system is to measure the events that occur during movement, data on time and space is measured and walking speed
SMART STEP
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
is an instrument which provides feedback during walking about the amount of burden that the patient places on his leg. A feedback about placing the burden on the whole foot, toes or on the heel is possible. Investigators will set the minimal and maximal weight that we want the patient to reach while stepping. When the patient reaches the minimal weight, he will hear a single pip and when he reaches the maximal weight or more, he will hear two pips. In other words, this instrument gives us an indication for the patient's carrying of the weight- how much weight he placed on the leg while walking on each area and indication for the duration of the foot placed on the ground and in the air
BBS (Berg Balance Scale)
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
the test includes 14 static and dynamic tasks for keeping balance. Each task receives a score from 0 to 4 points- according to the quality of task and performance time, maximal score of 56 points. Instructions regarding performing each task separately and the score of each task appear in the test form. The low performance in each task is considered in the score. In most tasks the patient is asked to keep a specific pose for a while. The score must be decreased if the patient does not meet the requirements of wished time or distance or if he gets external support or assisted by the tester.
4 secondary outcomes
TUGT (Times Up And Go):
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
THE FIVE SIT-TO-STAND TEST
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
MLEFS- LOWER EXTREMITY FUNCTIONAL SCALE
Time frame: Base line; change after 6 weeks treatment; and change after 10 weeks
responsiveness to the treatment
Time frame: 6 weeks
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 17 Sep 2019.
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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.
Jean-Jeaques Vatine, Prof principal investigator
Reuth Rehabilitation Hospital
Alon Kalron, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training with video therapy and conventional exercise in people with Osteoarthritis, Hip and Hip Injuries, run by Reuth Rehabilitation Hospital at 1 site in Israel.
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 2 inclusion and 4 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 17 Sep 2019. 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 Israel. 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?
GAITMAT (time frame: Base line; change after 6 weeks treatment; and change after 10 weeks). The study lists 3 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 17 Sep 2019.