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Trial record 7 of 60 for:    LEAP

Leap Motion Based Exercises in Upper Extremity Rehabilitation of The Children (LMBE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Ela Tarakci, Istanbul University
ClinicalTrials.gov Identifier:
NCT03078998
First received: March 2, 2017
Last updated: March 8, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Rehabilitation Physical Therapy Device: Leap Motion Based Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: The Investigation of Effectiveness of Leap Motion Based Exercises in Upper Extremity Rehabilitation of The Children

Resource links provided by NLM:


Further study details as provided by Ela Tarakci, Istanbul University:

Primary Outcome Measures:
  • Jebsen Taylor Hand Function Test [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Nine Hole Peg Test [ Time Frame: 8 weeks ]
  • Childhood Health Assessment Questionnaire [ Time Frame: 8 weeks ]
  • Duruoz Hand Index [ Time Frame: 8 weeks ]

Enrollment: 60
Actual Study Start Date: April 1, 2016
Estimated Study Completion Date: July 15, 2017
Primary Completion Date: December 14, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Juvenile idiopathic Arthritis Device: Leap Motion Based Exercises
Game based exercise
Experimental: Obstetric Brachial Plexus Palsy Device: Leap Motion Based Exercises
Game based exercise
Experimental: Cerebral Palsy Device: Leap Motion Based Exercises
Game based exercise

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnosed cardiac or orthopedic disorders that may interfere with the application of evaluation methods,
  • Having a mental problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03078998

Sponsors and Collaborators
Istanbul University
The Scientific and Technological Research Council of Turkey
Investigators
Principal Investigator: Ela Tarakci Istanbul University
Study Director: Nilay Arman Istanbul University
Study Director: Devrim Tarakci Istanbul Medipol University
Study Chair: Yusuf Sinan Akgul Gebze Institute of High Technology
  More Information

Responsible Party: Ela Tarakci, Assoc.Prof., Istanbul University
ClinicalTrials.gov Identifier: NCT03078998     History of Changes
Other Study ID Numbers: 108400987275
Study First Received: March 2, 2017
Last Updated: March 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ela Tarakci, Istanbul University:
Juvenile Idiopathic Arthritis
Cerebral Palsy
Obstetric Brachial Plexus Palsy
Human Computer Interaction
Leap Motion
Video Game Based Rehabilitation

ClinicalTrials.gov processed this record on July 26, 2017