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CTRI Number  CTRI/2026/02/105081 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Computer Based training on attention and reactive time of Children With Cerebral Palsy 
Scientific Title of Study   Effect Of Computer Based Cognitive Training On Attention And Processing Speed In Children With Cerebral Palsy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshita Aden 
Designation  MPT (Neurology) student 
Affiliation  ISIC Institute Of Rehabilitation Sciences 
Address  Physiotherapy Department, ISIC Institute of Rehabilitation Sciences, Second floor, Room Number 1, opposite Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  09599967776  
Fax    
Email  adenharshita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Garima Wadhwa  
Designation  Assistant Professor 
Affiliation  ISIC Institute Of Rehabilitation Sciences 
Address  2nd Floor, Institute Department, Indian Spinal Injury Centre, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South West
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Garima Wadhwa  
Designation  Assistant Professor 
Affiliation  ISIC Institute Of Rehabilitation Sciences 
Address  2nd Floor, Institute Department, Indian Spinal Injury Centre, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070


DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ISIC Institute of Rehabilitation Sciences 
Address  2nd Floor, Institute Department, Indian Spinal Injury Centre, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Harshita Aden  ISIC Multispecialty Hospital  PMR Department, Ground Floor, Room number 3, opposite Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI 
09599967776

adenharshita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Computer Based Cognitive Training  A Desktop computer setup will be provided to seated children. Intervention includes the use of arrows keys and cursor. There will be 12 games, each lasting one minute that will be Repeated 2–3 times with progressive difficulty (5 minutes of total training time per game) Child will be provided rest as and when required Six games will be selected per session (rotated weekly) Duration: The session will last for 40 minutes, 4 days/ week for 4 weeks  
Comparator Agent  Paper And Pencil Cognitive Training  The child will be comfortably seated Clear instructions about the task will be provided, followed by two trial attempts The tasks will be obtained through worksheets When printed, the tasks will be solved on a table with a pencil Duration: The session will last for 40 minutes, 4 days/ week for 4 weeks  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age 8 to 12 years
Children with confirmed diagnosis of cerebral palsy
Intelligence quotient more than 80
Able to communicate and understand the instructions of game
Manual Ability Classification System levels I, II, or III 
 
ExclusionCriteria 
Details  Visual or auditory impairment that can limit the participation
Secondary orthopedic complications like contractures in the upper extremity that can limit the participation
History of seizures or epilepsy
Spasticity greater than or equal to 2 on Modified Ashworth Scale in the wrist and fingers that can limit the participation
Recent musculoskeletal injury or fracture in the upper extremity that can limit the participation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Digit Span Test  04 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Trail Making Test-A   04 weeks 
Stroop Color Word Test
 
04 weeks 
Go/No-Go Task
 
04 weeks 
Flanker’s Test  04 weeks 
Trail Making Test-B
 
04 weeks 
Connections
 
04 weeks 
Tower of London
 
04 weeks 
Pattern Comparison  04 weeks 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title

Effect of computer based cognitive training on attention and processing speed in children with cerebral palsy


Background

Children with cerebral palsy perform tasks slowly, often struggling to sustain attention and process information efficiently. Literature reports deficits in attention, processing speed, and executive functions in children with cerebral palsy compared to typically developing peers contributing to challenges in learning, behavior regulation, and overall daily functioning. 

Recent studies highlight the potential of computer-based cognitive training, which offers some benefits over traditional pencil-and-paper tasks for cognition in neurologically affected populations. Introducing gaming elements provides added motivation, improving therapy intensity, duration, and adherence. However, existing research largely emphasizes executive functions in isolation, with limited focus on attention and processing speed. The availability of low-cost, accessible computer-based tools for assessment and intervention remain underexplored. This study aims to address these gaps by evaluating targeted, low cost, easily available and engaging assessment tools and interventions.


OBJECTIVE

To evaluate the effect of computer-based cognitive training on attention in children with cerebral palsy

To evaluate the effect of computer-based cognitive training on processing speed in children with cerebral palsy.


HYPOTHESIS


Null hypothesis 

Hn1: There is no significant effect of computer-based cognitive training in comparison with paper-and-pencil cognitive training on attention in children with cerebral palsy.

Hn2: There is no significant effect of computer-based cognitive training in comparison with paper-and-pencil cognitive training on processing speed in children with cerebral palsy.


Alternate hypothesis

Ha1: There is significant effect of computer-based cognitive training in comparison with paper-and-pencil cognitive training on attention in children with cerebral palsy.

Ha2: There is significant effect of computer-based cognitive training in comparison with paper-and-pencil cognitive training on processing speed in children with cerebral palsy.



Material and Methods

(a) Study Design: Experimental study

(b) Sample size and method: 24, purposive sampling

(c)Enrolment period: 6-7 months after RRC and IEC clearance

(d) Total Study duration: 4 weeks

(e) Inclusion and exclusion criteria:


Inclusion criteria

Exclusion criteria

  • Age 8 to 12 years.

  • Visual or auditory impairment that can limit the participation 

  • Children with a confirmed medical diagnosis of Cerebral Palsy

  • Secondary orthopedic complications like contractures in the upper extremity that can limit the participation 

  • Intelligence Quotient more 80

  • History of seizures or Epilepsy 

  • Able to communicate and understand the instructions of game

  • Spasticity greater than or equal to 2 on Modified Ashworth Scale in the wrist and fingers that can limit the participation

  • Manual Ability Classification System levels I, II, or III 

  • Recent musculoskeletal injury or fracture in the upper extremity that can limit the participation


Study Procedures:

After RRC and IEC clearance, subjects will be assessed for eligibility. Pre-intervention tests will be carried out using Psychology Experiment Building Language (PEBL). Randomization will be done using simple random allocation software. Children will be divided into two groups, group-A and group-B.

Group A (Experimental group) will receive Computer Based Cognitive Training and Group-B (Control group) will receive Paper and Pencil Cognitive Training. Both interventions will be carried out for 40 minutes per session, 4 days per weeks for 4 weeks. Post-intervention tests will be carried out Psychology Experiment Building Language (PEBL) 

Assessment tools: From Psychology Experiment Building Language

For Attention :
Number sequencing subtest (Trail Making Test-A)
Digit span
Stroop Color Word Test
Go/No-Go Task
Flanker’s Test

For Processing Speed :
Letter Digit Substitution Task (Trail Making Test-B) 
Connections
Tower of London
Pattern Comparison


Statistical Analysis Plan (SAP): 

Descriptive statistics will be applied to calculate the mean and standard deviation for quantitative variables (age, Trail Making Test, Digit Span, Stroop Color Word Test, Go/No-Go Task, Flanker’s Test, Connections, Tower of London, Pattern Comparison) and frequencies with percentages for categorical variables (e.g., gender). Data normality will be assessed using the Shapiro-Wilk Test. If normally distributed, between-group differences in attention and processing speed (computer-based vs. paper-and-pencil training) will be examined using the independent t-test, while within-group changes will be analyzed using the dependent t-test. For skewed data, the Mann-Whitney U test will be applied for between-group comparisons, and the Wilcoxon signed-rank test for within-group changes across the outcome measures. Data will be initially managed in Excel and then imported into SPSS version 21 for Windows for analysis. Statistical significance will be set at a 5 percent alpha level to determine meaningful differences.


 
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