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CTRI Number  CTRI/2021/02/031411 [Registered on: 19/02/2021] Trial Registered Prospectively
Last Modified On: 18/02/2021
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   Comparison between Gluteal Exercises with Release and Release only on posture in Cerebral Palsy Children 
Scientific Title of Study   Comparison between combined effect of gluteal activation along with MFR and MFR only on crouch posture in children with spastic diplegia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha 
Designation  Student 
Affiliation  Punjabi University, Patiala 
Address  Department of Physiotherapy, Punjabi University, Patiala.
Department of Physiotherapy, Punjabi University, Patiala.
Patiala
PUNJAB
147001
India 
Phone  9815703053  
Fax    
Email  manisha03053@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Narkeesh Arumugam 
Designation  Head of department. 
Affiliation  Punjabi University, Patiala 
Address  |Department of physiotherapy, Punjabi University, Patiala, Punjab
Punjabi University, Patiala, Punjab
Patiala
PUNJAB
147001
India 
Phone  9417802662  
Fax    
Email  narkeesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manisha 
Designation  Student 
Affiliation  Punjabi University, Patiala 
Address  Department of Physiotherapy, Punjabi University, Patiala, Punjab
Department of Physiotherapy,Punjabi University, Patiala, Punjab
Patiala
PUNJAB
147001
India 
Phone  9815703053  
Fax    
Email  manisha03053@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Punjabi University, Patiala, Punjab 
 
Primary Sponsor  
Name  Punjabi University Patiala Punjab 
Address  Departmentt of Physiotherapy  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manisha  Punjabi University  Department of Physiotherapy. Physiotherapy OPD.
Patiala
PUNJAB 
9815703053

manisha03053@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group   Myofacial Release of iliopsoas along with tDCS with intensity 1mA and conventional physiotherapy for 60 min 5 days a week for 6 weeks. 
Intervention  Experimental group  Myofacial Release of iliopsoas along with gluteal activation and tDCS with intensity 1mA and conventional physiotherapy for 60 min 5 days a week for 6 weeks. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children with Spastic Diplegia.
2. Age group 10-18 years.
3. Both genders
4. Both males and females will be included in the study.
5. Children with GMFCS level 1,2,3 will be included
 
 
ExclusionCriteria 
Details  1. Those currently on any medication for CP.
2. Who had received botulinum toxin injection.
3. Who had undergone lower limb surgery within 6 months of study enrolment so as to avoid confounding results secondary to iatrogenic weakness.
4. Children with history of head injury or loss of consciousness, who has contracture, other co-morbid disorders such as Autism Spectrum disorder.
5. GMFCS level 4,5
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Hamstring flexibility test
2. APECS (A1 Posture Evaluation and Correlation System) app
3. Edinburg Visual Gait Score

 
day 0
day 21
day 42
 
 
Secondary Outcome  
Outcome  TimePoints 
pediatric balance scale  day 0
day 21
day 42 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   26/03/2021 
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="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


BACKGROUND

In spastic diplegia, lower extremities are more involved than the upper extremities. Children have major weakness in trunk. Postural disturbances in CP are major difficulty in maintaining body segments aligned on narrow base of support. Such children retain an anterior pelvic tilt, due to the tightness of the iliopsoas muscle as well as the weakness in the trunk flexors and hip extensors. Crouch gait is the most common locomotor disability among children with spastic diplegic CP. The activation of gluteus maximus muscle leads to improve crouched posture and gait in CP.

 

OBJECTIVE

To determine the combined effect of gluteal activation along with MFR and MFR only on crouch posture in children with spastic diplegia to improve standing posture and gait.

METHODOLOGY

Nature of the Study

The study will be Randomized Controlled Trial in which the effect of gluteal activation on crouch posture in spastic diplegic CP children will be observed.

SELECTION CRITERIA

Inclusion criteria

Children with Spastic Diplegia, age group 6-12 years, Both males and females, GMFCS level 1,2,3.

 

Exclusion criteria

 

·         Those currently on any medication for CP.

·         Who had received botulinum toxin injection.

·         Who had undergone lower limb surgery within 6 months of study enrolment so as to avoid confounding results secondary to iatrogenic weakness.

·         Children with history of head injury or loss of consciousness, who has contracture, other co-morbid disorders such as Autism Spectrum disorder.   

·         GMFCS level 4,5 

 

OUTCOME MEASURES

1. Hamstring flexibility test

2. APECS (A1 Posture Evaluation and Correlation System) app

3. Edinburg Visual Gait Score

4. Pediatrics Balance Scale

 

Procedure

The experimental group will be given MFR of iliopsoas + tDCS + Gluteal Activation exercises i.e. single leg bridging and step up exercises + Conventional Physiotherapy. The control group will be given MFR of iliopsoas and tDCS with conventional physiotherapy. After the administration of intervention, scores for Hamstring flexibility, standing posture analysis and gait analysis, Pediatric Balance Score will be recorded.

 

 

 

 

 

 

 

 

 

 

 

 

 

                                           

 

 
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