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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02451085
Other study ID # 2015-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date August 10, 2017

Study information

Verified date September 2019
Source Reuth Rehabilitation Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 10, 2017
Est. primary completion date August 10, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria:

- One to three months after hip surgery

- Age 50-85

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
training with video therapy
training with video therapy
conventional exercise
training in conventional way

Locations

Country Name City State
Israel Reuth Rehabilitation Hospital Tel Aviv

Sponsors (2)

Lead Sponsor Collaborator
Reuth Rehabilitation Hospital Video Therapy Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Base line; change after 6 weeks treatment; and change after 10 weeks
Primary 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 Base line; change after 6 weeks treatment; and change after 10 weeks
Primary 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.
Base line; change after 6 weeks treatment; and change after 10 weeks
Secondary 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. Base line; change after 6 weeks treatment; and change after 10 weeks
Secondary 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. Base line; change after 6 weeks treatment; and change after 10 weeks
Secondary 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 Base line; change after 6 weeks treatment; and change after 10 weeks
Secondary 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. 6 weeks
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