| CTRI Number |
CTRI/2022/10/046279 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Physiotherapy Exercise training in improving sitting control in children with cerebral palsy and thereby improving the quality of life of their mothers. |
|
Scientific Title of Study
|
Efficacy of sensory perceptual motor core stability training for the improvement of sitting control in children with cerebral palsy and its association with the quality of life of their mothers – A Randomised Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RATHISH S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
Mother Theresa Post Graduate and Research Institute of Health Sciences
Indira Nagar
Gorimedu Indira Nagar
Gorimedu
Puducherry 605006 Pondicherry PONDICHERRY 605006 India |
| Phone |
9944319384 |
| Fax |
0413-2277594 |
| Email |
rathish@mtpgrihs.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
RATHISH S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
Mother Theresa Post Graduate and Research Institute of Health Sciences
Indira Nagar
Gorimedu Indira Nagar
Gorimedu
Puducherry 605006 Pondicherry PONDICHERRY 605006 India |
| Phone |
9944319384 |
| Fax |
0413-2277594 |
| Email |
rathish@mtpgrihs.ac.in |
|
Details of Contact Person Public Query
|
| Name |
RATHISH S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
| Address |
Mother Theresa Post Graduate and Research Institute of Health Sciences
Indira Nagar
Gorimedu Indira Nagar
Gorimedu
Puducherry 605006 Pondicherry PONDICHERRY 605006 India |
| Phone |
9944319384 |
| Fax |
0413-2277594 |
| Email |
rathish@mtpgrihs.ac.in |
|
|
Source of Monetary or Material Support
|
| CENTRE FOR ACADEMIC RESEARCH
Rajah Muthiah Medical College
ANNAMALAI UNIVERSITY |
| Indira Gandhi Medial College and Research Institute IGMC & RI
Pondicherry
Puducherry 605009 |
| Mother Theresa Post Graduate and Research Institute of Health Sciences
Puducherry 605006 |
|
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Primary Sponsor
|
| Name |
RATHISH S |
| Address |
ASSISTANT PROFESSOR IN PHYSIOTHERAPY
Mother Theresa Post Graduate and Research Institute of Health Sciences
Puducherry |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RATHISH S |
Mother Theresa Post Graduate and Research Institute of Health Sciences |
I Floor
Room No 103 / Pediatric Physiotherapy lab
Indira Nagar
Gorimedu
Puducherry
6050006 Pondicherry PONDICHERRY |
9944319384 0413-2277594 rathish@mtpgrihs.ac.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE ECR/677/Inst/PY/2014/RR-17 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy Exercise Protocol |
Conventional Physiotherapy Exercise Protocol comprises of range of motion exercise, strength training, passive stretching, functional training, sitting balance training, and coordination training. Each exercise session will be for one hour, three times per week for successive 8 weeks. |
| Intervention |
Sensory perceptual motor core stability training |
Sensory perceptual-motor core stability program are a set of tailored facilitating exercises that will be done on an exercise ball, bolster on a different textured surface, with facilitation, targeting the core muscles with assistance and support wherever required and adequate rest period. This refers to a movement program designed to enhance the interaction of children with other persons, objects, and their environment in an attempt to develop the perceptual motor attributes of laterality , differentiality, directionality, body image, form perception, balance, hand-eye coordination, ocular control, and gross motor coordination. The child will be trained on trunk activities over sagittal plane in sitting (stability) for reaching task in upper limb (mobility) by targeting the core muscles. The therapist facilitate the child by hands on to meet the requirements of the task by providing optimal alignment of the pelvis for the weight shifts at hips and elongation of the trunk toward the reaching side of the task. The child will be further challenged for a transverse plane activities through tactile, vestibular, proprioceptive, visual-spatial orientation of gross motor accommodation The therapist present an environmental modification requiring a small movement or postural challenge to the child and waited for the child to solve the problem, and choose their own movement strategy giving very light cues or assistance. The focus is on helping the child utilize forces to obtain a functional goal through problem solving and engaging the core muscles. Each exercise session will be for one hour, three times per week for successive 8 weeks. |
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children with spastic cerebral palsy aged 3 to 7 years who are able to follow verbal commands with no cognitive impairment and categorized as level III Gross Motor Function Classification System (GMFCS) will be included in the study.
Mothers having and living with cerebral palsied children included in this study
|
|
| ExclusionCriteria |
| Details |
Children with Cerebral Palsy who are uncooperative, having visual or intellectual impairments.
Children with Cerebral Palsy on antiepileptic and antispasticity medications,
Children with Cerebral Palsy having hearing deficit any cardiac anomalies affecting exercise tolerance, and less than 4 months after undergoing orthopedic surgery or botulinum toxin injections.
Other types of cerebral palsy
Attention deficit hyperactivity disorder and Dyspraxic child.
Mothers of these having another patient or disabled individual along with the Cerebral Palsied child at home are excluded from the study
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trunk control measurement scale (TCMS) |
Baseline, 6 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| World Health Organization Quality of Life Assessment (WHOQOL-BREF) |
Baseline, 6 weeks and 8 weeks |
|
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Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
17/10/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rathish@mtpgrihs.ac.in].
- For how long will this data be available start date provided 08-08-2022 and end date provided 14-12-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
INTRODUCTION Cerebral palsy (CP) is a chronic condition that affects children and has adverse impact on social, physical activity, and participation in daily life. Functional impairments developing due to physical, cognitive, emotional, and social disorders prevent children with CP from performing their roles in society. Families of children with CP fail to fulfill their social role concerning the children and themselves because of children’s continuous requirements for special care, frequent medical checkups, and continuous physiotherapy treatment and to take over their roles in society. Sitting is the earliest upright posture achieved during normal development. The capacity to maintain balance in sitting is a prerequisite to the activities of daily living. Core stability is the ability to control the position and movement of the central portion of the body. Children with cerebral palsy have poor core control, which affects sitting balance. Impaired sitting balance affects the level of participation in daily activities and increases the burden on the mothers thus affecting their quality of life. The loss of trunk control is a very important element that causes difficulties not only in sitting but also while playing in sitting positions, functional hand movements such as eating and maintaining activities of daily living. Children with cerebral palsy may not complete these movements sufficiently due to poor posture, weak trunk muscles, and insufficient trunk stability. Delay in the acquisition of neck and trunk response affects the development of muscular strength and limits the overall activity of the child during sitting, playing, and feeding. This leads to the loss of other milestones that might affect the overall quality of life of the child and increase the caretaking burden Aim: The aim of this study is to evaluate the effect of sensory perceptual-motor core stability exercise program to gain sitting milestone in children with cerebral palsy and thereby improving the quality of life of their mothers Research Hypothesis Sensory Perceptual Motor Core Stability program is effective for improving the sitting control in children with cerebral palsy and thereby improving the quality of life of their mothers. Primary Objective: To evaluate the effect of sensory perceptual motor core stability exercise program for improving sitting control in children with cerebral palsy as measured by trunk control measurement scale (TCMS) Secondary Objective To evaluate the effect of improved sitting control among the children with cerebral palsy on the quality of life of their mothers as measured by WHO QOL BREF. METHODOLOGY The study is double blinded, Randomised Controlled Trial to be conducted in the community and special schools at Puducherry. The outcomes are to be assessed at baseline, 6 months and at 8 months. The research hypothesis is sensory perceptual-motor core stability training will improve sitting control in cerebral palsied children as measured by the trunk control measurement scale (TCMS). The study intends to calculate the mean score of TCMS in both groups. As sitting control is the primary objective of the study the mean change in the TCMS, score will be analysed statistically to find out the significance between both groups. The study expects the mean change in the experimental group will be significant when compared with the control group and thus will benefit cerebral palsied children to gain sitting control. The study expects a considerable proportional of children achieving and improving sitting control and thereby a proportional improvement in their mothers quality of life as measured by WHOQOL – BREF (World Health Organisation Quality of life) |