| CTRI Number |
CTRI/2025/06/088251 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cold therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of effectiveness of Cold therapy on spasticity among children with cerebral palsy |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of cold therapy on spasticity among children with cerebral palsy at selected EIC in Western Maharashtra. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Liji Abraham |
| Designation |
PG trainee |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
MSc Nursing Child Health Nursing First Year Trainee Officer College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9503388273 |
| Fax |
|
| Email |
oceanglowpath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayalakshmi A S |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
Child Health Nursing College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9560604892 |
| Fax |
|
| Email |
jaya22118@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Liji Abraham |
| Designation |
PG trainee |
| Affiliation |
College of Nursing AFMC Pune |
| Address |
MSc nursing Child Health Nursing First year trainee officer College of Nursing Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9503388273 |
| Fax |
|
| Email |
oceanglowpath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Southern Command Pune |
|
|
Primary Sponsor
|
| Name |
Liji Abraham |
| Address |
College of Nursing Armed Forces Medical College Solapur Pune Highway Wanowrie Pune 411040 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Ms Liji Abraham |
Command Hospital |
Early Intervention Centre physiotherapy department southern Command Golibar Maidan Wanwadi Pune
Pune
MAHARASHTRA |
9503388273
oceanglowpath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Armed Forces Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (2) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, (3) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold therapy |
Application of cold or ice pack to the affected limb with spasticity for 15 mins prior to receiving the standard treatment of physiotherapy or occupational therapy as prescribed twice a week for 4 weeks. |
| Comparator Agent |
Standard treatment |
The children receives the standard treatment of physiotherapy and occupational therapy as prescribed by the physician. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with spastic cerebral palsy
Children with mild to moderate degree of spasticity in the upper limbs or lower limbs
Mothers of children with spastic cerebral palsy who knows Hindi or English or Marathi and who are willing to give consent.
|
|
| ExclusionCriteria |
| Details |
Children with fixed contractures or deformities in the affected limb
Previous surgical intervention in the affected limb
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| degree of spasticity |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/08/2025 |
| 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="0"
Months="6"
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 randomized controlled trial aims to evaluate the effectiveness of cold therapy in reducing spasticity among children with spastic cerebral palsy attending physiotherapy at selected early intervention centres in tertiary care hospitals in Western Maharashtra. A total of 50 children aged 2 to 12 years with mild to moderate spasticity will be recruited using systematic random sampling. Participants will be randomly allocated into control and intervention groups with 25 children in each group. The intervention group will receive cold therapy applied for 15 minutes to the affected limb before physiotherapy or occupational therapy twice a week for four weeks. The control group will receive standard therapy alone. Spasticity levels will be assessed before and after the intervention using the Modified Ashworth Scale. The study aims to compare spasticity levels between and within groups and determine any association with selected demographic variables. This research will provide evidence on the effectiveness of cold therapy as a non pharmacological intervention in the management of spasticity in children with cerebral palsy.
|