Computer Application (ICOGNI) Based Training Along With Routine Physical Therapy on Executive Functions and Motor Skills in Cerebral Palsy

May 26, 2022 updated by: University of Lahore

Effects of Computer Application (ICOGNI) Based Training Along With Routine Physical Therapy on Executive Functions and Motor Skills in Cerebral Palsy

This study design will be randomized controlled trial. Subjects will be selected for data collection from the Physiotherapy Department, Institute of Pediatric and Rehabilitation of The University of Lahore Teaching Hospital and Central Park Teaching Hospital, Lahore. Subjects will be randomly allocated into two equal groups, conventional group (group A) and an experimental group (group B). Conventional group will be receiving routine physical therapy and Experimental group will be receiving Computer application-based training and routine physical therapy. Pre and post intervention data will be taken from Gross Motor Function Classification System, Manual Ability Classification System, Mini-Mental State Examination for Children and Quality of Upper Extremity Skills Test for data analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study design will be randomized controlled trial. Subjects will be selected for data collection from the Physiotherapy Department, Institute of Pediatric and Rehabilitation of The University of Lahore Teaching Hospital and Central Park Teaching Hospital, Lahore. Subjects will be randomly allocated into two equal groups, conventional group (group A) and an experimental group (group B). Conventional group will be receiving routine physical therapy and an Experimental group will be receiving Computer application-based training and routine physical therapy. Training will be given once a day, five times a week for total 8 weeks. For conventional group, the training duration for each session will be 30 minutes with 5 minutes of rest period and for experimental group, 60 minutes with 10 minutes of rest period in between. Participants in conventional group will be given routine physiotherapy which will include range of motion exercises, stretching and strengthening exercises of upper extremity, fine motor activities, functional activities, and cognitive activities (art and crafts, placing objects in specific positions, organizing objects, color sorting games, teamwork, and moving and tracing objects). Participants in experimental group will be given routine physiotherapy along with App-based training. The routine physiotherapy will be the same as given to the control group and app-based training will include multiple games with multiple levels. Pre and post intervention data will be taken from Gross Motor Function Classification System, Manual Ability Classification System, Mini-Mental State Examination for Children and Quality of Upper Extremity Skills Test for data analysis. For the assessment of executive function skills, Mini-mental State Examination For Children (MMC) will be used and for motor skills, Quality Of Upper Extremity Skills Test (QUEST) will be used.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 55150
        • Recruiting
        • The University of Lahore
        • Contact:
        • Principal Investigator:
          • Hadeeqa Momin, MSPTN*
        • Sub-Investigator:
          • Arooj Munawar, Phd*
        • Sub-Investigator:
          • Anam Naz, MSPTN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ranges from 8-16 years.
  • Children with diagnosed spastic unilateral CP
  • Who are able to follow instructions
  • Respond to visual and auditory stimuli
  • Who are able to handle computer/ tablet
  • School going children
  • One of the parents should be literate
  • MMC score less than 24 (mild to moderate impairment)
  • GMFCS level 2

Exclusion Criteria:

  • Presence of epilepsy
  • Complex communication disorders
  • Any surgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer Application (ICOGNI) Training
Apart from routine physical therapy, participants in this group will be randomized to active training after baseline assessment. Participants will be given App-based training which will include multiple games with multiple levels along with routine physiotherapy. The active group will start training immediately and will have 8 weeks to perform the 40 training sessions.
Other: Computer Application (ICOGNI) Training
Participants will be given App-based training under supervision for 40 sessions, which will include multiple games with multiple levels along with routine physiotherapy.
No Intervention: Conventional group
Participants in are already being given routine physiotherapy which includes range of motion exercises, stretching and strengthening exercises of upper extremity, fine motor activities, functional activities, and cognitive activities (art and crafts, placing objects in specific positions, organizing objects, color sorting games, teamwork, and moving and tracing objects).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination for Children (MMC)
Time Frame: 8 weeks
Mini-Mental State Examination for Children (MMC) is an adapted version of the Mini-Mental State Examination. The Mini-Mental Examination for Children(MMC) is a widely used tool for assessing global cognitive deficits with a maximum score of 37.
8 weeks
Quality of Upper Extremity Skills Test (QUEST)
Time Frame: 8 weeks
Quality of Upper Extremity Skills Test (QUEST) is a reliable measure of gross motor upper limb functions in children with CP. This measure assesses mainly four domains: dissociated movement, grasp, protective extension, and weight bearing.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Hadeeqa Momin, MSPTN*, The University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2021

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/1001/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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