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RehabilitationLMBENCT03078998

Leap Motion Based Exercises in Upper Extremity Rehabilitation of The Children

A study testing Leap Motion Based Exercises in people with Rehabilitation and Physical Therapy, run by Istanbul University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Juvenile Idiopathic Arthritis (JIA), Cerebral Palsy (CP), and Obstetric Brachial Plexus Injury (OBPI) are the most common disorders that cause upper extremity impairments in children. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Rehabilitation, Physical Therapy
What is being tested?
Leap Motion Based Exercises
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Apr 2016to 15 Jul 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 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Juvenile idiopathic Arthritis, Cerebral Palsy, Obstetric Brachial Plexus Palsy have been diagnosed,
  • 5-17 years of age,
  • In the last 6 months, no other treatment, such as Botarinium Toxin (BOTOX) injection, intraarticular injection, surgery, which can affect extremity rehabilitation,
  • Upper extremity Modified Ashworth Scale (0), (1), (1+) for children wtih Cerebral palsy
  • Having the ability to adapt to exercises

Who cannot join

  • Diagnosed cardiac or orthopedic disorders that may interfere with the application of evaluation methods,
  • Having a mental problem

About this study

Official title: The Investigation of Effectiveness of Leap Motion Based Exercises in Upper Extremity Rehabilitation of The Children

Juvenile Idiopathic Arthritis (JIA), Cerebral Palsy (CP), and Obstetric Brachial Plexus Injury (OBPI) are the most common disorders that cause upper extremity impairments in children. Depending on the underlying pathologies, the common symptoms of these disorders are the limitations of the upper extremity joint movement angles, muscle imbalance and the functional limitations caused by the contracture due to these problems. Daily life activities such as feeding, personal care, and self mobility activities that use upper extremity are commonly limited with these children. Physical rehabilitation is mostly used to address these problems. However, the process of rehabilitation is difficult and lengthy. In addition, most of the time, classical rehabilitation is discouraging for many young patients. Employment of digital technology has been gaining momentum in addressing the above rehabilitation problems among the medical professionals.

By utilizing exciting new sensor technologies, such as Microsoft Kinect, Nintendo Wii and Leap Motion, practical game based rehabilitation applications have been becoming popular. Video Based Games (VBG) that adopt the these technologies as Human Computer Interaction (HCI) interfaces are recently used successfully for the task of rehabilitation. The Leap Motion device, one of the new examples of these technologies, has a very small form factor. It includes two near infrared stereoscopic cameras to capture hand images of patients to produce 3 Dimensional (3D) positions of hand joints at a very fast rate with a sufficient positional precision.

Read more

There have been examples that use motion sensor based VBG's for the rehabilitation of different types of patient groups. Compared to classical rehabilitation practices, these applications provide many advantages such as ease of use, repeatableness, and instantaneous measurable feedback. In addition, the young patients involved in these applications demonstrated willingness to participate in these activities and they showed considerable progress in upper extremity rehabilitation. However, these VBG's were mostly developed for general public and it was often suggested to develop VBG's for the specific task of upper extremity rehabilitation of children. It is known that upper extremity specific VBG's and their applications are very limited both at the global and domestic levels.

With this project, we plan to design and develop specialized Leap Motion based VBG's for the children diagnosed with JIA, CP, and OBPI. These VBG's will be designed to be easy to use and motivating for the children. They will automatically lead the patients to correct hand exercises and they will provide mechanisms for online performance measurements of the patients. The performance results from the patients will be compared with the results from the classical rehabilitation applications by the standards of The International Classification of Functioning (ICF). These games will provide complete Turkish language support for the extended national dissemination of the project outputs.

The proposed project is inherently a multi disciplinary work that requires very close interaction of phisiotherapists, software experts, and HCI specialists and efficient application of the these games for the patients. There will be specialized games for each disorder. These games will utilize the outputs from the Leap Motion device that will produce 3D hand joint positions and joint angles. Realistic animations of hand and virtual environments will provide a motivating exercise game platform for the patients.The performance measurements of the patients will be repeated for each game session. There will be game parameters for the game duration, difficulty level, and hand joints in focus. The game hand movements will reflect daily life activities for the rehabilitation purposes which would make our games different from the general public games. The project findings at end of the project on best game usage frequency and durations, the effectiveness of the designed VBG's and other results will be shared with the scientific community through publications and seminars.

Being tested
Leap Motion Based Exercises
Keywords
Juvenile Idiopathic Arthritis, Cerebral Palsy, Obstetric Brachial Plexus Palsy, Human Computer Interaction, Leap Motion, Video Game Based Rehabilitation
Medical subject headings
Arthritis, Juvenile, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leap Motion Based ExercisesDevice

    Game based exercise

Study groups in NCT03078998
Study groupRoleWhat they receive
Juvenile idiopathic ArthritisExperimentalNot described
Receives: Device: Leap Motion Based Exercises
Obstetric Brachial Plexus PalsyExperimentalNot described
Receives: Device: Leap Motion Based Exercises
Cerebral PalsyExperimentalNot described
Receives: Device: Leap Motion Based Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Jebsen Taylor Hand Function Test

    Measured: 8 weeks

Secondary outcomes (3)
  1. Nine Hole Peg Test

    Measured: 8 weeks

  2. Childhood Health Assessment Questionnaire

    Measured: 8 weeks

  3. Duruoz Hand Index

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start1 Apr 2016
  3. Primary completion14 Dec 2016
  4. Study completion15 Jul 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078998
Sponsor's protocol ID
108400987275
Acronym
LMBE
Status last verified
Apr 2018
First submitted
2 Mar 2017
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Leap Motion Based Exercises in people with Rehabilitation and Physical Therapy, run by Istanbul University.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Jebsen Taylor Hand Function Test (time frame: 8 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 20 Apr 2018.

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