| CTRI Number |
CTRI/2025/08/092304 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Home based computer game therapy to improve hand function in children with cerebral palsy. |
|
Scientific Title of Study
|
Effectiveness of telerehabilitation in improving hand function in children with cerebral palsy through computer game-based therapy: an experimental pre- and post-study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amruta M Malaganavar |
| Designation |
Post graduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Medical Sciences and Hospital SDM University Paediatric Physiotherapy Department , 1st floor , old building Opd no 13
SDM College Of Physiotherapy SDM University Sattur , Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7019664360 |
| Fax |
|
| Email |
amrutamm2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay parmar |
| Designation |
Professor, PG guide and Principal |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Medical Sciences and Hospital SDM University Paediatric Physiotherapy Department , 1st floor , old building Opd no 13
SDM College Of Physiotherapy SDM University Sattur , Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
|
| Email |
sanjaytparmar777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amruta M Malaganavar |
| Designation |
Post graduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Medical Sciences and Hospital SDM University Paediatric Physiotherapy Department , 1st floor , old building Opd no 13
SDM College Of Physiotherapy SDM University Sattur , Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7019664360 |
| Fax |
|
| Email |
amrutamm2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital, paediatric physiotherapy opd no 13 old building sattur dharwad 580009
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Amruta M Malaganavar |
| Address |
SDM college of Physiotherapy sattur dharwad karnataka 580009 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amruta M Malaganavar |
SDM college of Medical Sciences and Hospital |
Paediatric Physiotherapy OPD no 13, old building, sattur, Dharwad 580009
Dharwad
KARNATAKA |
7019664360
amrutamm2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM COLLEGE OF MEDICAL SCIENCES & HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer Game Based Therapy |
Participants will first undergo a supervised clinical training phase where they will be introduced to a structured hand arm exercise program using 6 to 8 motor skill objects designed to improve fine motor skills, grasping, and coordination. These objects vary in size, shape, weight, and surface texture, and act as input devices connected to an inertial based computer mouse system, integrated with commercially available computer games.
Children and caregivers will be trained to use the system, with tasks tailored to the child level of impairment. Exercises include unimanual and bimanual activities targeting fingers, wrist, elbow, and shoulder like soccer ball rolling, cone grasping, fine finger rotation, key grasping.
If child presents with additional impairments like trunk or lower limb involvement, or sensory issues a tailored exercise protocol will be designed and taught to caregivers at home.
After the training participants will begin an 8 week home based telerehabilitation phase, performing 30 to 45 minute sessions, 5 times per week, using the game based rehabilitation system at home under caregiver supervision and remote monitoring.
|
| Intervention |
No comparator group is used in this study |
This is a single arm interventional trial using an inertial sensor based mouse system integrated with computer games for home based telerehabilitation in children with cerebral palsy. Participants first undergo supervised training in a clinic, followed by an 8 week home based program 30 to 45 min per day, 5 days per week targeting fine motor skills, grasp, and coordination through individualized tasks using motor skill objects.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with age groups 5 to 12 years
of either gender.
2. Children diagnosed with CP by a medical
practitioner.
3. Pediatric version of mini mental state
evaluation score 17 and above.
4. Children with upper limb spasticity
level 1-2 on modified modified ashworth
scale.
5. Parents must be educated enough to
understand instructions and possess the
knowledge to support the child
participation in the intervention
6. Parents should have ability to possess a
computer or laptop with a stable internet
connection.
7. Manual ability classification system level 1 to 3 |
|
| ExclusionCriteria |
| Details |
1. Children with significant visual,
auditory or perceptual problems.
2. Children with fixed deformities in the
affected upper limb
3. Non-willing parent.
4. Children with severe cognitive
impairments.
5. Recent botulinum toxin therapy (less
than 6 months).
6. Uncontrolled Seizures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) QUEST (Quality of upper extremity skill test)
b) PDMS-2 (Peabody developmental motor scale-2)
c) ABILHAND-Kids Questionnaire
d) CUE-Computer Game–Based Upper Extremity Assessment of Manual Dexterity. |
Baseline
Mid intervention-at 4 weeks
Post intervention-at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This study aims to evaluate the effectiveness of telerehabilitation using computer game based therapy in improving hand function in children with cerebral palsy. The study includes children aged five to twelve years diagnosed with cerebral palsy. Participants will receive supervised training in a clinical setting followed by eight weeks of home based rehabilitation using an inertial based computer mouse system connected to computer games. Tasks or therapy will be tailored based on individual needs and abilities and progression will be done according to it. Therapy will be conducted for 30 to 45 minutes per session 5 times per week. Standardized outcome measures such as the peabody developmental motor scale, quality of upper extremity skills test, computer game based upper extremity assessment, and abilhand kids questionnaire will be used for assessment which will be taken at the baseline, mid intervention at 4 weeks and post intervention at 8 weeks. The study will seek to determine improvements in fine motor skills and participation in daily activities. The results will contribute to developing accessible, cost effective, and engaging rehabilitation strategies for children with cerebral palsy using digital platforms at home.
|