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CTRI Number  CTRI/2021/09/036837 [Registered on: 24/09/2021] Trial Registered Prospectively
Last Modified On: 14/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To compare effect of scapula stabilizing exercises and scapula PNF technique on scapular alignment and activity of daily living in stroke patients 
Scientific Title of Study   COMPARATIVE STUDY OF IMMEDIATE AND SHORT TERM EFFECT OF 4 DAYS OF SCAPULAR STABILIZING EXERCISES AND SCAPULAR PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION ON SCAPULAR ALIGNMENT AND FUNCTIONAL TASK IN PATIENTS WITH STROKE”-An Experimental Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prachi Bhagat 
Designation  1st MPT,Neurophysiotherapy 
Affiliation  DR. Vitthalrao Vikhe Patil Foundation,College of Physiotherapy 
Address  Department of Neurophysiotherapy,DVVPFs, College of Physiotherapy

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  7768815938  
Fax    
Email  prachibhagat007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suvarna Ganvir 
Designation  Professor and HOD 
Affiliation  DR. Vitthalrao Vikhe Patil Foundation,College of Physiotherapy 
Address  Department of neurophysiotherapy, DVVPFs College of physiotherapy, opp.Govt.Milk Dairy, M.I.D.C, Ahmadnagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9372910683  
Fax    
Email  suvarna.ganvir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suvarna Ganvir 
Designation  Professor and HOD 
Affiliation  DR. Vitthalrao Vikhe Patil Foundation,College of Physiotherapy 
Address  Department of neurophysiotherapy, DVVPFs College of physiotherapy, opp.Govt.Milk Dairy, M.I.D.C, Ahmadnagar

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9372910683  
Fax    
Email  suvarna.ganvir@gmail.com  
 
Source of Monetary or Material Support  
DVVPFsCollege of Physiotherapy,oppo.Govt Milk Dairy,MIDC,Ahmadnagar-414111  
 
Primary Sponsor  
Name  DVVPFs College of physiotherapy 
Address  College of physiotherapy, opp.Govt.Milk Dairy,M.I.D.C, Ahmadnagar 414111 
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 
Prachi Bhagat  DVVPFs College of physiotherapy  Department of Neurophysiotherapy, Opp.Govt.Milk Dairy,M.I.D.C, Ahmadnagar
Ahmadnagar
MAHARASHTRA 
07768815938

prachibhagat007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical 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  Scapula Stabilizing exercises  Scapula stabilizing exercises giving T,Y and I position - 6 seconds hold 3 sets of 15 repititions and 1 minute interval between each set for 30 minutes 
Comparator Agent  Scapular Proprioceptive neuromuscular facilitation   Scapular Proprioceptive neuromuscular facilitation by using Rhythmic initiation and repeated contractions with 20 repititions for Anterior elevation and posterior depression and posterior elevation and anterior depression for 30 minutes 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Gender: males and females
Patients with acute and sub-acute stroke
Patients with spasticity Grade 0 to Grade 1+
Patients with Static and Dynamic balance in
sitting
Brunstorm recovery beyond stage 3
Patients able to follow command 
 
ExclusionCriteria 
Details  Patients with shoulder subluxation
Patients undergone any surgery related to shoulder joint .
Musculoskeletal injuries such as fractures, dislocation or any soft tissue injuries on affected side or non-affected side.
Patients with Neurological conditions other than stroke. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Palpation Meter,Stopwatch  0.1.2.3.4.days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 23/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
It will be published soon 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Stroke is the common neurological disorder causing impairment of upper limb functions. Upper limb inacapacity is the big issue and it contributes greatly to functional disability after Stroke. Patients have poor voluntary control and muscle weakness of arm and body malalignment which increases the incidence of dependence in ADL activity immediately after Stroke.

Scapula Stabilizing Exercises and Scapula PNF have both proved to be effective in improving the motor function of upper limb and ADL activity. But in the busy clinical set up, we need to choose one technique which is more efficient. So the study was done to investigate comparison between both the techniques and effect of these techniques on Scapular Algnment and Functional task.

An Experimental Study was conducted in tertiary care hospital 18 patients diagnosed with Stroke were recruited as per the inclusion and exclusion criteria.After obtaining the ethical approval from Instituitonal Ethical Committee, enrollment of the participants began. Written informed consent was explained and undersigned by the patients which were included in the study.The patients were divided into two group with the help of allocation method .Scapula Stabilizing Exercises and Scapula PNF were given to Group A and Group B respectively. Scapula Alignment with the help of Palpation meter (PALM) and Functional task in terms of Lifting and lowering the cup was taken at baseline and for four consecutive days.

The data obtained was then analyzed statistically. The results showed significant improvement in both the techniques i.e. there is decrease in the Total Height discrepancy and time taken for lifting and lowering the cup. Scapula Proprioceptive Neuromuscular Facilitation Exercises was found to be more effective than Scapula Stabilizing Exercises.


 
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