| CTRI Number |
CTRI/2025/06/088889 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Trunk Control and Mobility in Children with Cerebral Palsy Using Game-Based and Traditional Therapy |
|
Scientific Title of Study
|
Effect of computerized interactive game-based intervention as an adjunct to conventional therapy on trunk control and functional mobility in children with cerebral palsy spastic diplegia aged 6-12 years. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Kolhe |
| Designation |
Postgraduate Student - MPT |
| Affiliation |
All India Institute Of Physical Medicine and Rehabilitation Mumbai |
| Address |
Room no 223,2nd Floor,All India Institute Of Physical Medicine and Rehabilitation ,KK Marg ,Haji Ali, Mahalakshmi, Mumbai
Mumbai
MAHARASHTRA
400034
India
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9119445305 |
| Fax |
|
| Email |
snehakolhe23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Ravindran |
| Designation |
Lecturer & HOD |
| Affiliation |
All India Institute Of Physical Medicine and Rehabilitation Mumbai |
| Address |
Room no 223,2nd Floor,All India Institute Of Physical Medicine and Rehabilitation ,KK Marg ,Haji Ali, Mahalakshmi, Mumbai
Mumbai
MAHARASHTRA
400034
India
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820264446 |
| Fax |
|
| Email |
ravindranlecturerpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Ravindran |
| Designation |
Lecturer & HOD |
| Affiliation |
All India Institute Of Physical Medicine and Rehabilitation Mumbai |
| Address |
Room no 223,2nd Floor,All India Institute Of Physical Medicine and Rehabilitation ,KK Marg ,Haji Ali, Mahalakshmi, Mumbai
Mumbai
MAHARASHTRA
400034
India
Mumbai
MAHARASHTRA
400034
India |
| Phone |
9820264446 |
| Fax |
|
| Email |
ravindranlecturerpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,All India Institute Of Physical Medicine and Rehabilitation ,KK Marg ,Haji Ali, Mahalakshmi, Mumbai
Mumbai
MAHARASHTRA
400034
India |
|
|
Primary Sponsor
|
| Name |
Sneha Kolhe |
| Address |
Department of Physiotherapy, AIIPMR, KK Marg ,Haji Ali, Mahalaxmi,
Mumbai
MAHARASHTRA
400034
India |
| 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 |
| DrSneha Kolhe |
AIIPMR |
Department of Physiotherapy, Room no 223 All India Institute Of Physical Medicine and Rehabilitation ,KK Marg ,Haji Ali, Mahalakshmi, Mumbai
Mumbai
MAHARASHTRA
400034
India
Mumbai
MAHARASHTRA |
09119445305
snehakolhe23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, AIIPMR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computerized interactive game |
• Using the computerized force plate (TYMO) force and weight distribution will be calibrated by asking the child to move the trunk forward, backward and sideways as far as she/he can in static sitting position in each treatment session.
• The amplitude of the force and weight distribution between the two sides of the body will be recorded and this information will be used to set up the Tymo as a balance training module by the software, in which the child will move the trunk forward, backward and sideways to participate in computer game in sitting position.
• Children will be allowed to play computer game in sitting with hips and knees at 90 degree and both feet supported.
• The participants needed to shift their centre of pressure through trunk movements while sitting on force plate (TYMO)
• The game will be started at a medium – low level of difficulty
• If the child is unable to score for 3 consecutive trails the difficulty level will be reduced by 1 level
• Similarly, if the child scores full points for 3 consecutive trails the difficulty level will be raised by 1 level.
• Duration –3 days/ week for 4 weeks for 15 minutes.
Along with that the children will receive conventional therapy.
|
| Comparator Agent |
Conventional Therapy |
Pelvic bridging.
Abdominal crunches.
Upper trunk rotation by bringing clasped hands on either side.
Forward and lateral reaches.
trunk rotation in sitting.
duration - 3days/week for 4 week for 45-60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with cerebral palsy spastic diplegia, GMFCS level II-III
Age – 6 to 12 years
Able to ambulate a distance of 10 m independently
|
|
| ExclusionCriteria |
| Details |
Children with visual and hearing impairments. Children with epilepsy or seizure disorders. Children with cognitive impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trunk Control Measurment Scale (TCMS)
Time Up and Go (TUG) |
Pre-Intervention and Post 4 weeks of Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3 |
|
Date of First Enrollment (India)
|
26/06/2025 |
| 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 Yet Recruiting |
| 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
|
Cerebral palsy is the most common physical disabilities in childhood. It is a non-progressive lesion of the developing central nervous system affecting the control of movements and posture in the children.Numerous studies have shown that children with CP ,regardless their GMFCS levels, demonstrate problems in their postural control in sitting and standing positions, which in turn affect their function and participation in daily life. The main deficits in postural control in sitting for children with CP are lack of ability to recruit direction-specific muscles in more severe children or inability to fine-tune the degree of muscle contraction according to specific situations in less disabled children when their sitting balance is challenged.Achieving independent sitting is a fundamental ability that acts as a precursor for reaching ,performing activities of daily living and attaining other functional skills ,that relies on considerable postural and trunk control. postural control focuses on the orientation of various body segments in space ,that serves as a reference frame for perception and action to external surroundings ; while trunk control is the ability specific to controlling orientation of only the upper body ( trunk/torso) in space.. Trunk control plays central role in providing stable base of support during static and dynamic activities and is an important component of assessment in children with CP. Trunk control develops progressively in cranio-caudal direction that is acquired segmentally through increased control at various trunk segments during the development of independent sitting. The aim of this study is to determine the effect of computerized interactive game-based intervention as an adjunct to conventional therapy on trunk control and functional mobility in children with cerebral palsy spastic diplegia aged 6-12 years. The objective of this study is to assess and compare the effect of conventional training with computerized interactive game-based intervention on trunk control and functional mobility. Methodology- This is an experimental study .36 participants diagnosed with cerebral palsy spastic diplegia will be included as per inclusion and exclusion criteria . convenient sampling will be done . Pre intervention scores will be assessed using trunk control measurement scale[TCMS] and Time up Go [TUG] test. Participants will be allocated into 2 groups of 18 in each. Group 1 will be given computerized interactive game-based intervention and conventional trunk control exercises for 60 minutes. Group 2 will be given conventional trunk control exercises for 45-60 minutes . Both group will be given the above intervention 3 times per week for 4 weeks . Post 4 weeks ,intervention scores will be assessed using the mentioned outcome measures. Data will be collected in Microsoft Excel. Statistical analysis- Descriptive statistics will be used to summarize the data. Collected data will be tested for normality. If the data passes normality, between group comparison will be done using un-paired t test and within group comparison will be done using paired t test will be done.
If the data doesn’t pass normality , between group comparison will be done using Mann Whitney U test and within group comparison will be done using wilcoxin sign rank test will be done. |