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CTRI Number  CTRI/2024/02/063115 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 17/02/2024
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 OF PELVIC PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION AND BACKWARD WALKING ON BALANCE AND GAIT IN HEMIPARESIS 
Scientific Title of Study   COMPARISON OF PELVIC PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION AND RETROWALKING ON BALANCE AND GAIT IN INDIVIDUALS WITH HEMIPARESIS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saloni Dijeshbhai Gandhi 
Designation  Post Graduate 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060

Ahmadabad
GUJARAT
380060
India 
Phone  9537111925  
Fax    
Email  salonidgandhi2608@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaishali Suthar 
Designation  Lecturer, PhD. and PG Guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060

Ahmadabad
GUJARAT
380060
India 
Phone  9913806872  
Fax    
Email  vaishu82in@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vaishali Suthar 
Designation  Lecturer, PhD. and PG Guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060


GUJARAT
380060
India 
Phone  9913806872  
Fax    
Email  vaishu82in@gmail.com  
 
Source of Monetary or Material Support  
Saloni Dijeshbhai Gandhi Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060 
 
Primary Sponsor  
Name  Saloni Dijeshbhai Gandhi 
Address  Ahmedabad Institute of Medical Sciences AIMS Campus, Nr S.P. Ring Road, Ognaj circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060 
Type of Sponsor  Private medical college 
 
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 
Dr Vaishali Suthar  Ahmedabad Institute of Medical Sciences  Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060
Ahmadabad
GUJARAT 		 9913806872

vaishu82in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pelvic Proprioceptive Neuromuscular Facilitation  5 days a week for a period of 4 weeks 
Comparator Agent  Retrowalking  5 days a week for a period of 4 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Males and females.
Individuals with hemiparesis.
Age: 40 to 70 years of age.
Individuals who are able to follow commands.
Participants who are able to walk for 10 meter.
Brunnstorm recovery stage ≥ 3.
 
 
ExclusionCriteria 
Details  The subjects who are not willing to participate.
Participants who has received Botoux injection within past 6 months.
The subject who doesn’t follow the command.
Modified Ashworth score ≥ 3.
Uncooperative participants.
Any severe musculoskeletal disorder of spine and lower limb.
Any severe neurological condition except stroke.
Participants with severe disabling arthritis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale  At baseline and at the end of 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
10 meter walk test  At baseline and at the end of 4th week 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   29/02/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
AIM OF THE STUDY:
Aim of the study is to compare the effect of pelvic proprioceptive neuromuscular facilitation and retrowalking on balance and gait in individuals with hemiparesis.

OBJECTIVES OF THE STUDY:
 To find out the effect of pelvic PNF on balance in hemiparetic individual by BERG BALANCE SCALE.
 To find out the effect of pelvic PNF on gait in hemiparetic individual by10 METER WALK TEST.
 To find out the effect of retrowalking on balance in hemiparetic individual by BERG BALANCE SCALE.
 To find out the effect of retrowalking on gait in hemiparetic individual by 10 METER WALK TEST.
 To compare the effect of pelvic PNF versus retrowalking therapy on balance in hemiparetic individual by BERG BALANCE SCALE.
 To compare the effect of pelvic PNF versus retrowalking therapy on gait in hemiparetic individual by 10 METER WALK TEST.
 
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