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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399810
• Other study ID #: IRB-UOL-FAHS/1001/2021
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2022
• Source: University of Lahore
• Contact: Muhammad Haider Ullah Khan, MSPTN
• Phone: 03314127210
• Email: haiderullah[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic

Intervention

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.

Locations

Country	Name	City	State
Pakistan	The University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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