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CTRI Number  CTRI/2023/05/052930 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study on the effects of proprioceptive Neuromuscular Facilitation and Conventional physiotherapy treatment on upper limb and gait function in stroke subjects.  
Scientific Title of Study   Efficacy of Scapular and Upper Limb Proprioceptive Neuromuscular Facilitation Techniques on Scapular Alignment, Upper Limb Function, and Gait in Subacute Stroke: A Randomized 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  Akshaya Virendra Saklecha 
Designation  PG Student 
Affiliation  Ravi Nair Physiotherapy College 
Address  Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8862004846  
Fax    
Email  akshayasaklecha32@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammed Irshad Qureshi 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College 
Address  Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9406010010  
Fax    
Email  irshadphysio@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammed Irshad Qureshi 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College 
Address  Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha


MAHARASHTRA
442001
India 
Phone  9406010010  
Fax    
Email  irshadphysio@rediffmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha, Maharashtra, India.  
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College 
Address  Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) Wardha.  
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 
Akshaya Virendra Saklecha  Ravi Nair Physiotherapy College  Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA 		 8862004846

akshayasaklecha32@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: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional exercises  It includes closed kinematic chain exercises, range of motion exercises for the upper and lower extremity, stretching and strengthening exercises for upper limb, trunk and lower limb, coordination, manual dexterity exercises (e.g. grasp release), and teaching of daily living activities (ADLs), according to patient’s needs. It will be performed for 6 weeks, 5 days per week. 
Intervention  Scapular and upper limb Proprioceptive Neuromuscular Facilitation   Scapular and upper limb proprioceptive neuromuscular facilitation techniques will be applied to the participants in this group followed by conventional exercises. A physiotherapist will deliver treatment for 5 days a week for 6 weeks.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient with hemiplegic subacute stroke between 3-6 months, both male and female aged from 50-70 years
2. Patients with more than 24 in Mini-mental state examination
3. Patients with spasticity between grades (+1 and 1) on the Modified Ashworth Scale (MAS).
4. Patients with Brunnstrom Voluntary control grading more than or equal to 4
5. Patients who were independent in ambulation with or without a walking aid
 
 
ExclusionCriteria 
Details  1. patients who have uncontrolled hypertension, symptomatic heart failure, or unstable angina.
2. patients who have a recurrent stroke.
3. patients who have any traumatic upper and lower limb musculoskeletal conditions.
4. patients who had organ damage such as lung, heart, kidney, or liver failure. 
 
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.Palpation Meter (PALM)
2.Fugl-Meyer Assessment of Upper Extremity (FMA-UE)
3.10-Meter Walk Test (10MWT)
 		 Outcomes will be assessed at baseline and after
6 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Handheld Dynamometer
2. Dynamic gait index (DGI)
 		 Outcomes will be assessed at baseline and after
6 weeks. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   27/05/2023 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Email Id- akshayasaklecha32@gmail.com

  6. For how long will this data be available start date provided 27-05-2023 and end date provided 19-05-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The aim of this study is to find out the efficacy of Scapular proprioceptive neuromuscular facilitation combined with upper limb proprioceptive neuromuscular facilitation techniques and conventional therapy on scapular alignment, upper limb function, and gait in sub-acute stroke.

 
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