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Trial record 7 of 87 for:    Developmental Disabilities | ( Map: Canada )

Game-Based Rehabilitation Platform for Children With Neurodevelopmental Disorders and Acquired Brain Injuries

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ClinicalTrials.gov Identifier: NCT02728375
Recruitment Status : Unknown
Verified March 2016 by University of Manitoba.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborators:
SDM College of Physiotherapy
Christian Medical College and Hospital, Ludhiana, India
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
This research project focuses on the evaluation of an engaging exercise and cognitive computer game-based platform and embedded assessment tools for use in clinical practice and its transition to use in the home, and elementary classrooms. The goal of our research program is to produce innovative therapeutic point-of-care and cost-effective delivery system leading to better long-term health outcomes for toddlers and children with neurodevelopmental disabilities. The program is grounded on our technological developments and on current research documenting the benefits of computer-aided learning tools, exercise gaming applications in rehabilitation and principles of adaptive learning and neuroplasticity. We will conduct a randomized controlled trial to study the feasibility and effectiveness of a computer-aided, game-based repetitive task practice (RTP) program designed for training of fine and gross motor skills of the hand-arms and psychomotor skills (which) in young children with CP.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: computer game based rehabilitation protocol Other: Conventional therapy protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovative Game-Based Rehabilitation Platform for Children With Motor and Cognitive Impairments Due to Neuro-developmental Disorders and Acquired Brain Injuries
Study Start Date : April 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Computer gaming hand exercise regimen
Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 45 minutes,three times per week for sixteen weeks
Other: computer game based rehabilitation protocol
Participants who consent to take part in the study will be asked to use objects instrumented with the miniature motion mouse to play various therapeutic yet entertaining games while handling and moving the test therapeutic objects as a part of experimental therapy protocol. The objects used will be everyday items; a) lifting/rotating a sports ball small beach ball which requires bimanual handling, b) rolling a cylinder object (diameter 6-10 cm with fingers extended and using elbow and shoulder motion, c) grasping grasp small glass and then a sponge ball with whole hand and rotating (supination- pronation motion) d) motion of a small wand (pencil) with 3-finger pinch grip and using hand-wrist motion, and e) turning of a key with 2-finger pinch fine finger control. These objects represent a wide range of physical properties requiring different modes of manipulation and functional demands sufficient to test the assessment tool.

Active Comparator: Conventional hand exercise program
Exercises targeted to improve finger range of motion and hand strength. The exercises will be performed 45 minutes, three times per week for sixteen weeks
Other: Conventional therapy protocol
In control group: 1) Stretching of Biceps, Lattisimusdorsi, Pronators, Thumb muscles. 2) Weight Bearing Exercises. 3) CIMT for 20 min per day for 3-4 weeks, repeat each task 15-20 times. Pegboard activities, Rings: reaching- removing and putting back, Ball throw (under and over arm) - at basket which is kept 10 to 15 meter distance, opening bottle cap (large size bottle), Opening and closing door handle activity, Holding water bottle, bag in hand and transfer to 10 to 20 meter distance, Crumbling paper, Clay activities, Picking marbles from sand 4)Hand arm bimanual activities: Throwing ball with both hands, Holding ball with both hands and transfer, Holding bolster and keeping at place, Holding notebook in both hands, Holding rack with both hands, Holding plate in one hand and spoon in other hand, Pushing door or wall both hands.




Primary Outcome Measures :
  1. Quality of Upper Extremity Skills Test [ Time Frame: Change from baseline at 16 weeks and 6 months. ]
  2. Peabody Developmental Motor Scale- 2 Fine motor Quotient [ Time Frame: Change from baseline at 16 weeks and 6 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with Cerebral Palsy
  • Age between 4-11 years
  • Moderate upper extremity impairments and fine motor control abnormalities along with mild-moderate cognitive impairment.

Exclusion Criteria:

  • Child with visual impairment.
  • Auditory impairment
  • Orthopedic conditions such as recent fractures, fixed deformities of upper limb
  • Any surgical intervention 6 months before the study or who intended to receive within the period of study.
  • Non willing parents.

Tools For screening:

  1. Manual Ability Classification System (MACS) (Scores: Level 2, 3 and 4)
  2. Gross Motor Function Classification Scale (GMFCS) (Scores: Level 2, 3 and 4)
  3. Mini mental state examination scale for Children (23 and above out of 30)
  4. Ashworth scale for spasticity of hand and arm (Level 1, 1+, 2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728375


Contacts
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Contact: Tony Szturm, Ph.D. tony.szturm@umanitoba.ca
Contact: Anuprita Kanitkar, M.Sc. 12048813112 kanitkaa@myumanitoba.ca

Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Contact: Tony Szturm, PT, PhD    2047874704    tony.szturm@med.umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
SDM College of Physiotherapy
Christian Medical College and Hospital, Ludhiana, India
Investigators
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Principal Investigator: Tony Szturm, Ph.D. Associate Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02728375     History of Changes
Other Study ID Numbers: H2016:061
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Brain Injuries
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic