| CTRI Number |
CTRI/2022/07/043890 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
institutional physiotherapy in cerebral palsy |
|
Scientific Title of Study
|
Intensive Institutional Physical therapy intervention in children with Cerebral Palsy, GMFCS level II and III- Single group Pre-Post. |
| Trial Acronym |
IIPTI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARMAR SANJAY TEJRAJ |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR, SATTUR, DHARWAD KARNATAKA
Dharwad
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
08362462253 |
| Email |
sanjaytparmar777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARMAR SANJAY TEJRAJ |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR, SATTUR, DHARWAD KARNATAKA
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
08362462253 |
| Email |
sanjaytparmar777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIL KM |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR, SATTUR, DHARWAD KARNATAKA
sdm college of medical sciences and hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
9880260626 |
| Fax |
2462253 |
| Email |
sunilkm789@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR SATTUR DHARWAD |
|
|
Primary Sponsor
|
| Name |
DR PARMAR SANJAY TEJRAJ |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR, SATTUR, DHARWAD KARNATAKA |
| 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 PARMAR SANJAY TEJRAJ |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL SDM COLLEGE OF PHYSIOTHERAPY MANJUSHREE NAGAR, SATTUR, DHARWAD KARNATAKA
Dharwad
KARNATAKA |
09845340450
08362462253
sanjaytparmar777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
PHYSICAL THERAPY AT INSTITUTE LEVEL |
Total 10 participants (convenient sampling) will be studied for the inclusion and exclusion criteria. And will be pre and post assessed on outcome measures like GMFM-66,10 QUEST, CPQOL,11 Trunk Impairment Scale12 (TIS) and Problem list after every 50 sessions. Parent interview to be conducted post 1 month of intervention and the end of intervention will be analysed using qualitative analysis. Total 4 hours of therapy (2 hr in the morning and 2 hr in the afternoon) along with home programme exercise of 3 hours per sessions of physiotherapy will be given for5- 6 days/week for 24 weeks of duration. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
• Inclusion criteria :
1. Children falling in age group of 3 to 7 years.
2. Children diagnosed as cerebral palsy
3. Children able to follow commands
4. Children of either gender
5. Hypertonia in any one of the limb
6. Children of GMFCS level II and III
7. MACS level I-III
|
|
| ExclusionCriteria |
| Details |
• Exclusion criteria of case-control:
1. Children with other diagnosis than CP.
2. Children who underwent surgeries and botulinum toxin.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gross motor function measurement 66.cerebral palsy -quality of life |
0 -8-16-24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parents problem , trunk impairment scale |
baseline -8 week -16 week -24 week |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "3"
Final Enrollment numbers achieved (India)="3" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2022 |
| Date of Study Completion (India) |
06/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
‘Cerebral palsy (CP) describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The overall pooled prevalence of cerebral palsy per 1000 children surveyed was 2.95. Sub-group analysis for rural, urban and mixed rural-urban study population demonstrated the pooled prevalence as 1.83 , 2.29 and 4.37 respectively. The problems encountered in a child with CP are abnormal gross and fine motor functioning and organization that reflects abnormal motor control are the core features of CP. The motor problem leads to difficulties with walking, feeding and swallowing, coordinated eye movements, articulation of speech, and secondary problems with behaviour, musculoskeletal function, and participation in society. Physiotherapy is essential in the management of CP, and almost all people with the condition receive it. The goals of physiotherapy are to facilitate the child’s participation needs and to reduce the physical impairments caused by the symptoms. Physiotherapy assists children with CP in reaching their full potential for physical independence and fitness levels, as well as improving the children’s and their families quality of life by minimising the impact of their physical impairments. Physiotherapy includes a use of variety of therapeutic interventions to improve voluntary movement autonomy, strength, and coordination. This study includes the children with CP of GMFCS level II and III and effect of Intensive Physical therapy will be measured for a duration of 6 months.Until now, the intensive protocol, which includes the most effective interventions, has not been studied with 3-4 hours per day for up to 5-6 months. As a result, the purpose of this single group feasibility study is to investigate the outcome of intensive institutional physiotherapy intervention.
|