Clinical trial NCT05399810: Computer Application (ICOGNI) Based Training Along With Routine Physical Therapy on Executive Functions and Motor Skills in Cerebral Palsy
Official title: Effects of Computer Application (ICOGNI) Based Training Along With Routine Physical Therapy on Executive Functions and Motor Skills in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 62
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Examination for Children (MMC)
timeFrame: 8 weeks
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Hadeeqa Momin, MSPTN*
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.