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The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures

Primary Purpose

Elbow Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Telerehabilitation
Rehabilitation
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Fractures focused on measuring Telerehabilitation, Elbow fractures, Arthrolysis, MediTouch, Occupational Therapy, Active exercises

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize

Exclusion Criteria:

  • Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele rehabilitation

rehabilitation

Arm Description

Telerehabilitation:The subjects in the study group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly . At home they will be asked practice daily active exercises with the Meditouch Ltd. system.

Traditional Occupational Therapy:The subjects in this group will receive three treatments in the clinic every week. At home they will be asked to practice daily active exercises in the same level of difficulty and duration as the study group but without the Meditouch Ltd. system

Outcomes

Primary Outcome Measures

Range of motion

Secondary Outcome Measures

The Disabilities of the arm, shoulder and hand questionnaire (Dash),
The Patient-Rated Elbow Evaluation (PREE)
Jebsen and Taylor functional test
Grip force

Full Information

First Posted
March 9, 2016
Last Updated
March 15, 2016
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02713958
Brief Title
The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures
Official Title
The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This experimental research aims to examine the efficacy of Telerehabilitation treatment using a computerized system (MediTouch) in improving the upper limb function post elbow fractures. 24 participants aged 18-80 who are post surgery to fixate elbow fractures or arthrolysis of the elbow will be invited to participate in the study. The subjects will be matched into two groups according to age and fracture type to study and control groups. Both groups will be treated for a month in ambulatory clinic in the hospital and will do self-practice at home according to a intervention protocol. The subjects in the experimental group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in the control group will receive three treatments in the clinic every week. Activity daily living (ADL), Range of Motion, Hand strength disability and pain will be assessed before and after the intervention in order to asse the efficacy of the intervention.
Detailed Description
The elbow joint has an important role in the upper limb function. The rehabilitation process after injury is complex as a result of the common complications of the elbow after trauma, as stiffness, restriction in range of motion and occurrence of Heterotopic Ossification. According to the literature, early active mobilization reduces the incidence of these complications. Yet, current treatment protocols are based mainly on clinical experience and there is a lack in evidence-based trials regarding their efficiency. Recently, Occupational Therapists include Telerehabilitation in their treatments, using advanced technologies, which can be adapted to orthopedic injuries. The reported advantages of Telerehabilitation are the option to do self-practice without the need of arriving at a medical center and greater motivation to practice. This experimental research will examine the efficacy of Telerehabilitation treatment using a computerized system (MediTouch) in improving the upper limb function post elbow fractures. This research will include 24 participants aged 18-80, from the hand surgery unit in Sheba medical center, who are post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize. Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves will be excluded. The subjects will be matched into two groups according to age and fracture type to study and control groups. Both groups will be treated for a month in ambulatory clinic in the hospital and will do self-practice at home. The subjects in the study group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly, and the subjects in the control group will receive three treatments in the clinic every week. All subjects will be assessed before and after the intervention for hand function in everyday activities using The Jebsen-Taylor Hand Function Test, for disability and symptoms due to the injury using The Disabilities of the arm, shoulder and hand questionnaire, for pain and disability after injury in the elbow using The Patient-Rated Elbow Evaluation, for range of motion using Goniometer and for strength using Dynamometer. The Participants in the study group will also fill out questionnaires to evaluate level of satisfaction from the treatment and of the system usability. The hypotheses will be tested by the differences between groups in range of motion, function and satisfaction measures in order to assess the efficacy of the treatment in Telerehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fractures
Keywords
Telerehabilitation, Elbow fractures, Arthrolysis, MediTouch, Occupational Therapy, Active exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele rehabilitation
Arm Type
Experimental
Arm Description
Telerehabilitation:The subjects in the study group will receive two treatments in Telerehabilitation and one treatment in the clinic weekly . At home they will be asked practice daily active exercises with the Meditouch Ltd. system.
Arm Title
rehabilitation
Arm Type
Active Comparator
Arm Description
Traditional Occupational Therapy:The subjects in this group will receive three treatments in the clinic every week. At home they will be asked to practice daily active exercises in the same level of difficulty and duration as the study group but without the Meditouch Ltd. system
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Telerehabilitation: Telerehabilitation treatment using a computerized system (MediTouch) for improving the elbow motion
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Traditional Occupational Therapy treatment: Active exercises for elbow motion
Primary Outcome Measure Information:
Title
Range of motion
Time Frame
Change of range of motion in degrees from baseline up to 6 weeks
Secondary Outcome Measure Information:
Title
The Disabilities of the arm, shoulder and hand questionnaire (Dash),
Time Frame
Change of Dash score from baseline up to 6 weeks
Title
The Patient-Rated Elbow Evaluation (PREE)
Time Frame
Change of PREE score from baseline up to 6 weeks
Title
Jebsen and Taylor functional test
Time Frame
Change of Jebsen score from baseline up to 6 weeks
Title
Grip force
Time Frame
Change of grip force in kg from baseline up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize Exclusion Criteria: Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram Palti, Md
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures

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