NCT02713958

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 9, 2016

Last Update Submit

March 15, 2016

Conditions

Elbow Fractures

Keywords

TelerehabilitationElbow fracturesArthrolysisMediTouchOccupational TherapyActive exercises

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    Change of range of motion in degrees from baseline up to 6 weeks

Secondary Outcomes (4)

  • The Disabilities of the arm, shoulder and hand questionnaire (Dash),

    Change of Dash score from baseline up to 6 weeks

  • The Patient-Rated Elbow Evaluation (PREE)

    Change of PREE score from baseline up to 6 weeks

  • Jebsen and Taylor functional test

    Change of Jebsen score from baseline up to 6 weeks

  • Grip force

    Change of grip force in kg from baseline up to 6 weeks

Study Arms (2)

Tele rehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation

rehabilitation

ACTIVE COMPARATOR

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

Other: Rehabilitation

Interventions

TelerehabilitationOTHER

Telerehabilitation: Telerehabilitation treatment using a computerized system (MediTouch) for improving the elbow motion

Tele rehabilitation
RehabilitationOTHER

Traditional Occupational Therapy treatment: Active exercises for elbow motion

rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Elbow Fractures

Interventions

TelerehabilitationRehabilitation

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ram Palti, Md

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy of Occupational Therapy department

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 21, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

March 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)