| 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 |
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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
|
|
|
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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
|
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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
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant Blinded |
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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 |
|
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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
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|
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 | | | | | | | | | | |
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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