NCT05399810

Brief Summary

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.

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
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

June 1, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 12, 2022

Last Update Submit

May 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mini-Mental State Examination for Children (MMC)

    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)

    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

Study Arms (2)

Computer Application (ICOGNI) Training

EXPERIMENTAL

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

Conventional group

NO INTERVENTION

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).

Interventions

Participants will be given App-based training under supervision for 40 sessions, which will include multiple games with multiple levels along with routine physiotherapy.

Computer Application (ICOGNI) Training

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 55150, Pakistan

RECRUITING

Related Publications (2)

  • Pirila S, van der Meere JJ, Rantanen K, Jokiluoma M, Eriksson K. Executive functions in youth with spastic cerebral palsy. J Child Neurol. 2011 Jul;26(7):817-21. doi: 10.1177/0883073810392584. Epub 2011 Mar 11.

    PMID: 21398561BACKGROUND
  • Boyd RN, Baque E, Piovesana A, Ross S, Ziviani J, Sakzewski L, Barber L, Lloyd O, McKinlay L, Whittingham K, Smith AC, Rose S, Fiori S, Cunnington R, Ware R, Lewis M, Comans TA, Scuffham PA. Mitii ABI: study protocol of a randomised controlled trial of a web-based multi-modal training program for children and adolescents with an Acquired Brain Injury (ABI). BMC Neurol. 2015 Aug 19;15:140. doi: 10.1186/s12883-015-0381-6.

    PMID: 26286324BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hadeeqa Momin, MSPTN*

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Haider Ullah Khan, MSPTN

CONTACT

Ashfaq Ahmad, Phd

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 12, 2022

First Posted

June 1, 2022

Study Start

December 31, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

June 1, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations