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 STROKEâ€-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
|
|
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
|
|
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. |