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CTRI Number  CTRI/2021/10/037213 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 03/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Postural stability and transverse abdominis muscle activity in Parkinson patients 
Scientific Title of Study   Correlation Between Postural Stability And Transverse Abdominis Muscle Activity In Patients With Parkinson’s Disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gordon Anuj Miranda 
Designation  MPT 
Affiliation  Father Muller Medical College 
Address  Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7021078073  
Fax    
Email  gordonam.miranda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sydney Roshan Rebello 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9343569219  
Fax    
Email  sydnypt@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Gordon Anuj Miranda 
Designation  MPT 
Affiliation  Father Muller Medical College 
Address  Father Muller College of Allied Health Sciences, Physiotherapy Department, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7021078073  
Fax    
Email  gordonam.miranda@gmail.com  
 
Source of Monetary or Material Support  
Father Muller College of Allied Health Sciences, Kankanady, Mangalore, Dakshin Kanada, Karnataka, 575002 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Father Muller College Of Allied Health Sciences, Kankanady, Dakshin Kankanady, Mangalore, Karnataka- 575002 
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 
Gordon Anuj Miranda  Father Muller Medical College   Department Of Physiotherapy
Dakshina Kannada
KARNATAKA 
7021078073

gordonam.miranda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Mullers Institutional Ethics Committee (FMIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patient with Parkinsons
Modified H & Y stage- 1-3.5
The ability to move independently
 
 
ExclusionCriteria 
Details  Any lower limb surgeries in past 1 year
Any abdominal surgeries in past 1 year
Diabetic neuropathy
Vertigo
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale (BBS)
TUG test(timed up and go)
Pressure Bio-Feedback Stabilizer (PBFS)
 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Montreal Cognitive Assessment (MoCA)
MDS-UPDRS 
Baseline 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   21/10/2021 
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 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)?  

Response - NO
Brief Summary  

Parkinson disease is characterised as a progressive disorder of the central nervous system which consist of both motor and non-motor symptoms. The cardinal features are rigidity, bradykinesia tremors and as the disease progresses, postural instability are grouped under motor symptoms. Non motor symptoms usually occur before the onset of motor symptoms. Non motor includes loss of sense of smell, orthostatic hypertension, mood disorders, sleep ­­disorders, constipation, altered bladder function, cognitive problems and difficulty in speaking and swallowing. Parkinson disease affects an estimated population of 7-10 million worldwide.

Postural instability is one of the key signs in patients with Parkinson’s disease. Postural instability is the inability to maintain balance in an upright position in both static and dynamic conditions. It is present in some patients even at diagnosis and worsens with disease progression. It is due to abnormal postural reflexes, proprioceptive deficit, stooped posture and postural sway.

Transverse abdominis (TrA) is one of the primary abdominal muscles. Intra-abdominal anterior lumbopelvic postural stability is regulated by the diaphragm, pelvic floor and TrA. On the basis of feedforward principle, the TrA co-creates the internal cylinder of the abdominal cavity that secures the stability of the spine. Also, the TrA plays a major role in performing functional movements and in stabilizing the trunk when the balance of the body is getting affected in both static as well as dynamic conditions. TrA muscle performs its role most efficiently due to its fascia trailers among the other muscles such as diaphragm, lumbar muscle, multifidus muscle and pelvic floor muscles that support it.

Till date, no study has been conducted correlating the transverse abdominus activity and postural stability in Parkinson’s disease population. Hence, the purpose of this study is to find the correlation between the transverse abdominis activity for postural stability in population with Parkinson’s disease as TrA muscle’s normal function is regarded as significant in postural stability.

RESEARCH QUESTIONS:

Is there any correlation between the transverse abdominis activity and postural stability in Parkinson’s disease population?

 

HYPOTHESIS (H1): The transverse abdominis activity has a significant correlation with postural stability in Parkinson’s disease population.

 

NULL HYPOTHESIS (H0): The transverse abdominis activity has no significant correlation with postural stability in Parkinson’s disease population.


 
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