| 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
|
|
|
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
|
|
|
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 ÂÂdisorders, 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. |