NCT03078998

Brief 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. 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

March 2, 2017

Last Update Submit

April 19, 2018

Conditions

Keywords

Juvenile Idiopathic ArthritisCerebral PalsyObstetric Brachial Plexus PalsyHuman Computer InteractionLeap MotionVideo Game Based Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Jebsen Taylor Hand Function Test

    8 weeks

Secondary Outcomes (3)

  • Nine Hole Peg Test

    8 weeks

  • Childhood Health Assessment Questionnaire

    8 weeks

  • Duruoz Hand Index

    8 weeks

Study Arms (3)

Juvenile idiopathic Arthritis

EXPERIMENTAL
Device: Leap Motion Based Exercises

Obstetric Brachial Plexus Palsy

EXPERIMENTAL
Device: Leap Motion Based Exercises

Cerebral Palsy

EXPERIMENTAL
Device: Leap Motion Based Exercises

Interventions

Game based exercise

Cerebral PalsyJuvenile idiopathic ArthritisObstetric Brachial Plexus Palsy

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Juvenile idiopathic Arthritis, Cerebral Palsy, Obstetric Brachial Plexus Palsy have been diagnosed,
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, JuvenileCerebral Palsy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ela Tarakci

    Istanbul University

    PRINCIPAL INVESTIGATOR
  • Nilay Arman

    Istanbul University

    STUDY DIRECTOR
  • Devrim Tarakci

    Medipol University

    STUDY DIRECTOR
  • Yusuf Sinan Akgul

    Gebze Institute of High Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 14, 2017

Study Start

April 1, 2016

Primary Completion

December 14, 2016

Study Completion

July 15, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share