| CTRI Number |
CTRI/2019/09/021236 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study To FINDOUT The Effect Of Propioceptive Neuro Muscular Facilitation Stretching On Balance And Gait In Spastic Diplegic Cerebral Palsy: |
|
Scientific Title of Study
|
A Study To Evaluate The Effect Of Propioceptive Neuro Muscular Facilitation Stretching On Balance And Gait In Spastic Diplegic Cerebral Palsy: An Interventional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Dabhi Sanjaybhai |
| Designation |
PG Student |
| Affiliation |
Neuromuscular department , room no 2,School Of Physiotherapy , RK University |
| Address |
NEUROMUSCULAR DEPARTMENT, ROOM NO. 2, 1ST FLOOR, School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9427721600 |
| Fax |
|
| Email |
mansidabhi18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Rakholiya |
| Designation |
Assistant Professor School of Physiotherapy RK. University |
| Affiliation |
Assistant Professor School of Physiotherapy RK. University |
| Address |
NEUROMUSCULAR, ROOM NO. 2, 1ST FLOOR ,School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9724779333 |
| Fax |
|
| Email |
shweta.rakholiya@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Rakholiya |
| Designation |
Assistant Professor School of Physiotherapy RK. University |
| Affiliation |
Assistant Professor School of Physiotherapy RK. University |
| Address |
NEUROMUSCULAR DEPARTMENT, ROOM NO. 2,1ST FLOOR, School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9724779333 |
| Fax |
|
| Email |
shweta.rakholiya@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| NEUROMUSCULAR DEPARTMENT, ROOM NO.2, 1ST FLOOR, School Of Physiotherapy, RK University.BHAVNAGAR HEIGHWAY,KASTURBADHAM,TRUMBA |
|
|
Primary Sponsor
|
| Name |
School Of PhysiotherapyRK University |
| Address |
neuromuscular department, room no.2,school of physiotherapy, RK university,bhavnagar highway,kasturbadham,tramba 360020,rajkot, gujarat,india |
| Type of Sponsor |
Other [Parent institute] |
|
|
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 |
| Drmahesh dabhi |
7plus child physiotherapy clinic |
ROOM NO.1, PEDIATRIC DEPARMENT, RUDRA PALZA, SHANALA ROAD, MORBI, GUJARAT,363641
Rajkot
GUJARAT |
7096720707
7pluschildphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee(IEC),school of physiotherapy rk. university. |
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 |
| Intervention |
Conventional Physiotherapy And Proprioceptive Neuromuscular Facilitation(PNF) Stretching |
Conventional therapy including Stretching and Strengthening exercise of lower limb For 30 Minutes Per Day For 5 Days Per Week For 4 weeks And Proprioceptive Neuromuscular Facilitation Stretching including hold relax and contract relax for 6-second hold and 10 repetitions for 5 days/week for 4 weeks. |
| Comparator Agent |
WeeFIM scale.
Tardieu scale.
Pediatric berg balance scale.
Gait parameters: - Stride length (cm), Cadence (steps/min). |
WeeFIM scale.
Tardieu scale.
Pediatric berg balance scale.
Gait parameters: - Stride length (cm), Cadence (steps/min). |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed as Diplegic cerebral
Palsy of both gender
age between 5-12 years
Gross motor function level I and II
Written consent from their parents
Able to follow simple verbal instructions
|
|
| ExclusionCriteria |
| Details |
Uncooperative subjects,
Uncontrolled epilepsy.
Receiving botulinum toxin injections or surgery no earlier than 6 months before project start.
Presence of shortening or deformities of the ankle, knee and/or hip joints that prevented the children from keeping their feet on the ground.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tardieu scale; AT DAY 1 AND AFTER 4WEEKS
Gait parameters: - Stride length (cm), Cadence (steps/min); AT DAY 1 AND AFTER 4WEEKS
|
Tardieu scale; AT DAY 1 AND AFTER 4WEEKS
Gait parameters: - Stride length (cm), Cadence (steps/min) AT DAY 1 AND AFTER 4WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WeeFIM Scale
Pediatric berg balance scale |
WeeFIM Scale; AT DAY 1 AND AFTER 4WEEKS
Pediatric berg balance scale; AT DAY 1 AND AFTER 4WEEKS
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/09/2019 |
| 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="6"
Days="0" |
|
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)?
|
|
Brief Summary
|
TOPIC: A STUDY TO EVALUATE THE EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION STRETCHING ON BALANCE AND GAIT IN SPASTIC DIPLEGIC CEREBRAL PALSY: AN INTERVENTIONAL STUDY.
Presented by Mansi Dabhi guided by Dr. Shweta Rakholiya Assistant Professor School of Physiotherapy RK. University.
KEYWORDS: SPASTIC DIPLEGIC CEREBRAL PALSY. PROPEOCEPTIVE NEUROMUSCULAR FACILITATION TECHNIQUE, GAIT, BALANCE BACKGROUND: Cerebral Palsy is a static, non-progressive disorder that results from brain insult or injury during any of the prenatal, perinatal and postnatal stages. Proprioceptive: - Having to do with any of the sensory receptors that give information concerning movement and position of body. Neuromuscular: - Involving the nerves and muscles. Facilitation: - Making easier.
AIM: Aim of the study is find effect of Proprioceptive neuromuscular facilitation technique on gait and balance in spastic diplegic cerebral palsy.
PROCEDURE: - Total 30 Subjects will be Included in Study according to Selection Criteria. They will be divided into 2 Groups, 15 Subjects in each group. In Group 1, 30 minutes of conventional physical therapy therapy + Propioceptive neuromuscular facilitation technique. Which include hold- relax and contract- relax for 6-second hold and 10 repetition for 5 days/week for 4 weeks. In Group 2, 30 minutes of conventional physical therapy. Then they will be assessed for baseline outcome measures WeeFIM scale, Tardieu scale, Pediatric berg balance scale, Gait parameters: - Stride length (cm), Cadence (steps/min) on day 1 and after 4 weeks. Statistical analysis will be done using SPSS Software.
|