| CTRI Number |
CTRI/2024/02/063128 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Core Stability and Pilates training on balance in Spastic Cerebral Palsy Children |
|
Scientific Title of Study
|
Comparison between Effects of Core stability and Pilates Training on balance in Spastic Cerebral Palsy Children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyamoli Sharma |
| Designation |
PG Student |
| Affiliation |
Amity University Noida, Uttar Pradesh |
| Address |
F-1 Block Lower floor Amity University, Sector 125, Gautam Buddha Nagar, Amity University Noida, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7086363424 |
| Fax |
|
| Email |
jupi5126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Amity University Noida, Uttar Pradesh |
| Address |
F-1 Block Lower floor Amity University, Sector 125, Gautam Buddha Nagar, Amity University Noida, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9810280418 |
| Fax |
|
| Email |
ngupta4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shyamoli Sharma |
| Designation |
PG Student |
| Affiliation |
Amity University Noida, Uttar Pradesh |
| Address |
F-1 Block Lower floor Amity University, Sector 125, Gautam Buddha Nagar, Amity University Noida, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
708363424 |
| Fax |
|
| Email |
jupi5126@gmail.com |
|
|
Source of Monetary or Material Support
|
| X-cell Physiocare, S-175, Greater Kailash, Basement, New Delhi,110048 |
|
|
Primary Sponsor
|
| Name |
Shyamoli Sharma |
| Address |
Room no LG12, F1 block, Lower Ground Floor, Amity University Noida, Uttar Pradesh, Gautam Buddha Nagar, Uttar Pradesh, 201301 |
| 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 Ankur Mittal |
X Cell Physiocare |
S 175 Basement Greater Kailash1 Room no 101 New Delhi
South
DELHI |
9990104050
info@xcellphysiocare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NTCC Ethical Clearance Certificate |
Approved |
| X-cell Physiocare |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80||Cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Stability Exercises and stretching |
Group A – Core Stability Exercises + stretching
The core stability exercises will be structured into three levels, with exercises lasting 30 minutes with 10 repetition,2 minutes rest period in between every exercise,four times a week.The levels consist of:
The first simple level with exercises such as supine abdominal draw-ins and supine twist.
The second medium level includes movements like pelvic bridging and twist with a medicine ball., and
The third difficult level comprised of actions like bridging with the head on a physioball and prone bridging.
|
| Comparator Agent |
Group B Pilates and Stretching |
Group B will given 10 minutes of stretching and Pilates exercises for 45 minutes, 10 repetition each, 2 sets, 2 minutes rest period, 4 times a week.Following are Pilates exercises:
1.shoulder bridge :Practiced in a crook lying position on a mat by raising the pelvis off the mat; advanced to using a medical ball under the lower leg while lifting the pelvis.
2.Single-leg circles: Practiced in a supine position on a mat by trying to make circles with each lower extremity, one at a time.
3.Alternate toe touch: Practiced on the mat by trying to touch the toes with both hips and knees in 90º flexion while alternating sides.
4.Ball leg lifts: Practiced by sitting on a medical ball and alternately raising each leg off the ground.
5. Standing splits: Practiced by standing on one leg with the other leg on a medical ball and moving the ball away from the stance leg and back.
6. Ball wall squat: Semi-squats performed while standing against a wall with a medical ball in the lumbar area.
7. Walking in tandem: Walking in a straight line from heel to toe |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with Spastic Cerebral Palsy.
Aged between 5 to 9 years.
Capable of following instructions and understanding either Hindi or English.
Parents or legal guardians of the children must provide their consent.
Flexibility of the lower back muscles must be normal
Spasticity should be ranging from 1 to 1+ (Modified Ashworth Scale)
Children classified as level 3 and 4 (Gross Motor Function Classification System)- GMFCS. |
|
| ExclusionCriteria |
| Details |
Children having fixed contractures, limb malformations or spinal malformations
Children having disorders associated with vision and respiration.
Children receiving rhizotomy toxin in the lower limb muscles within past 6 months will not be include. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Paediatric balance scale.
Modified time-up and go test |
4 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CP-QOL Questionnaire for assessing Quality of Living in Cerebral palsy children |
4 times |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
06/03/2024 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Enhancing core strength in individuals with spastic cerebral palsy has the potential to improve postural control, reduce the risk of falls, and increase independence in daily activities. Pilates training and core stabilization exercises are two commonly used approaches for achieving this goal. However, the lack of comparative studies addressing their relative effectiveness in the context of spastic cerebral palsy underscores the need for research in this area. Understanding which approach is more beneficial can assist healthcare professionals and therapists in tailoring interventions to individual needs. As healthcare increasingly shifts toward a patient-centered approach, it’s essential to involve individuals with spastic cerebral palsy in their rehabilitation decisions. Providing choices between Pilates training and core stabilization exercises empowers them to select interventions aligned with their preferences and goals. This research can contribute to personalized care plans that cater to individual needs and preferences. |