Elbow FracturesNCT02713958
The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures
A study testing Telerehabilitation and Rehabilitation in people with Elbow Fractures, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elbow Fractures
- What is being tested?
- Telerehabilitation and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize
Who cannot join
- Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Elbow Fractures
- Being tested
- Telerehabilitation, Rehabilitation
- Keywords
- Telerehabilitation, Elbow fractures, Arthrolysis, MediTouch, Occupational Therapy, Active exercises
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
Telerehabilitation: Telerehabilitation treatment using a computerized system (MediTouch) for improving the elbow motion
RehabilitationOther
Traditional Occupational Therapy treatment: Active exercises for elbow motion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measured: 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),
Measured: Change of Dash score from baseline up to 6 weeks
The Patient-Rated Elbow Evaluation (PREE)
Measured: Change of PREE score from baseline up to 6 weeks
Jebsen and Taylor functional test
Measured: Change of Jebsen score from baseline up to 6 weeks
Grip force
Measured: Change of grip force in kg from baseline up to 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 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FracturesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yafi Levanon PhD, Sheba Medical Center
- Investigators
- Ram Palti, Md, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713958
- Sponsor's protocol ID
- SHEBA-15-2296-RP-CTIL
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Telerehabilitation Program for Improvement of Upper Limb Function Among Adults Post Elbow Fractures
- ClinicalTrials.gov ID
- NCT02713958
- Acronym / sponsor ID
- SHEBA-15-2296-RP-CTIL
- Conditions
- Elbow Fractures
- Keywords
- Telerehabilitation, Elbow fractures, Arthrolysis, MediTouch, Occupational Therapy, Active exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Mar 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele rehabilitation | Experimental | Other: TelerehabilitationTelerehabilitation: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. |
| rehabilitation | Active comparator | Other: RehabilitationTraditional 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post surgery to fixate elbow fractures or arthrolysis of the elbow, which is steady to mobilize
Key exclusion criteria (1 listed)
- Patients diagnosed with rheumatology, neurological or orthopedic conditions and injuries in ligaments or nerves
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 |
|---|---|---|
| TelerehabilitationTelerehabilitation: Telerehabilitation treatment using a computerized system (MediTouch) for improving the elbow motion | Other | Tele rehabilitation |
| RehabilitationTraditional Occupational Therapy treatment: Active exercises for elbow motion | Other | rehabilitation |
Primary outcome
Range of motion
Time frame: Change of range of motion in degrees from baseline up to 6 weeks
4 secondary outcomes
The Disabilities of the arm, shoulder and hand questionnaire (Dash),
Time frame: Change of Dash score from baseline up to 6 weeks
The Patient-Rated Elbow Evaluation (PREE)
Time frame: Change of PREE score from baseline up to 6 weeks
Jebsen and Taylor functional test
Time frame: Change of Jebsen score from baseline up to 6 weeks
Grip force
Time frame: Change of grip force in kg from baseline up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Elbow Fractures
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Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
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This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
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.
Ram Palti, Md principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Rehabilitation in people with Elbow Fractures, run by Sheba Medical Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Mar 2016. 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?
Results are not available in the source record.
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?
Range of motion (time frame: Change of range of motion in degrees from baseline up to 6 weeks). 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 21 Mar 2016.