| 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
|
|
|
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
|
|
|
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.
|