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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings