NCT02728375

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 22, 2016

Last Update Submit

April 4, 2016

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Quality of Upper Extremity Skills Test

    Change from baseline at 16 weeks and 6 months.

  • Peabody Developmental Motor Scale- 2 Fine motor Quotient

    Change from baseline at 16 weeks and 6 months.

Study Arms (2)

Computer gaming hand exercise regimen

EXPERIMENTAL

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

Conventional hand exercise program

ACTIVE COMPARATOR

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

Interventions

computer game based rehabilitation protocolOTHER

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.

Computer gaming hand exercise regimen
Conventional therapy protocolOTHER

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.

Conventional hand exercise program

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (2)

  • Kanitkar A, Parmar ST, Szturm TJ, Restall G, Rempel G, Sepehri N. Parents' Perspectives on a Computer Game-Assisted Rehabilitation Program for Manual Dexterity in Children With Cerebral Palsy: Qualitative Analysis of Expectations, Child Engagement, and Benefits. JMIR Rehabil Assist Technol. 2021 May 31;8(2):e24337. doi: 10.2196/24337.

    PMID: 34057424DERIVED

  • Kanitkar A, Szturm T, Parmar S, Gandhi DB, Rempel GR, Restall G, Sharma M, Narayan A, Pandian J, Naik N, Savadatti RR, Kamate MA. The Effectiveness of a Computer Game-Based Rehabilitation Platform for Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2017 May 18;6(5):e93. doi: 10.2196/resprot.6846.

    PMID: 28526673DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tony Szturm, Ph.D.

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Szturm, Ph.D.

CONTACT

tony.szturm@umanitoba.ca

Anuprita Kanitkar, M.Sc.

CONTACT

12048813112kanitkaa@myumanitoba.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 5, 2016

Record last verified: 2016-03

Locations

CA(1)