NCT02451085

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

April 20, 2015

Last Update Submit

September 12, 2019

Conditions

Keywords

hipsurgeryReplacement

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • TUGT (Times Up And Go):

    Base line; change after 6 weeks treatment; and change after 10 weeks

  • THE FIVE SIT-TO-STAND TEST

    Base line; change after 6 weeks treatment; and change after 10 weeks

  • MLEFS- LOWER EXTREMITY FUNCTIONAL SCALE

    Base line; change after 6 weeks treatment; and change after 10 weeks

  • responsiveness to the treatment

    6 weeks

Study Arms (2)

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.

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.

Behavioral: conventional exercise

Interventions

training with video therapy

remote rehabilitation group

training in conventional way

conventional exercise group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One to three months after hip surgery
  • Age 50-85

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, HipHip Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesWounds and Injuries

Study Officials

  • Jean-Jeaques Vatine, Prof

    Reuth Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR
  • Alon Kalron, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

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 20, 2015

First Posted

May 21, 2015

Study Start

July 1, 2015

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations