| CTRI Number |
CTRI/2024/10/074741 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of Motor Imagery Training on
Balance and Postural Adjustment in Patient with Parkinsons Disease |
|
Scientific Title of Study
|
Effect of Motor Imagery Training on
Balance and Postural Adjustment in
Patient with Parkinsons Disease – A
Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Rai |
| Designation |
PG Student |
| Affiliation |
S S Agrawal institute of physiotherapy and medical care education navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus veranjali marg 1 devina park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974867068 |
| Fax |
|
| Email |
shrutirai88928@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zil Sutaria |
| Designation |
Assistant professor PG guide |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus verranjali marg 1 devina park
navsari
Navsari
GUJARAT
396445
India |
| Phone |
8469514632 |
| Fax |
|
| Email |
zilsutaria10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zil Sutaria |
| Designation |
Assistant professor PG guide |
| Affiliation |
S S Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
neuro out patient department ground floor s s agrawal institute of physiotherapy agrawal college campus verranjali marg 1 devina park
navsari
Navsari
GUJARAT
396445
India |
| Phone |
8469514632 |
| Fax |
|
| Email |
zilsutaria10@gmail.com |
|
|
Source of Monetary or Material Support
|
| SS agrawal institute of physiotherapy and medical care education, navsari, gujarat. 396445
agrawal college campus, out patient department, verranjali 1 marg, devina park, navsari. |
|
|
Primary Sponsor
|
| Name |
Shruti Rai |
| Address |
B-308, Vrundavan soc. Near St. Xaviers high school, koparli road, Chharwada, vapi-396191 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Shlesha Vaidya |
S S agrawal institute of physiotherapy and medical care education, navsari |
department of physiotherapy, ground floor, agrawal college
campus, viranjali marg, devina park,navsari
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee SS Agrawal institute of physiotherapy and medical care education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Motor Imagery and physical therapy
|
Motor imagery,Stretching, Strengthening exercise, Functional training for 3 times/ week for 6 week with duration 50-60 min.
|
| Comparator Agent |
Group 2- conventional therapy |
Stretching, strengthening exercise, functional mobility, balance training for 3 times/ week for 6 week with duration 50-60 min. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of PD by a neurologist
2. Age between 55 and 85 years
3. Hoehn and Yahr scale 1-3
4. Using Anti-parkinson medication-ON-state (1 hour after the last intake of
antiparkinsonian medication)
5. MMSE score 24 or more
6. Not having undergone stereotaxic surgery
7. No other musculoskeletal or neurological condition that affects balance
8. No vision or hearing problem
|
|
| ExclusionCriteria |
| Details |
1. Those exhibiting hemodynamic instability before or during training (systolic and diastolic
blood pressure above 180 mmHg and 110 mmHg, respectively)
2. Not willing to participate |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini- Balance Evaluation Systems test (Mini-BESTest) |
Baseline and 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM AND OBJECTIVES The study aims to find out the effect of motor imagery on balance and postural adjustment in individuals with Parkinsons disease. To compare the effect of motor imagery with conventional exercise for balance and postural adjustment in patients with Parkinsons disease. |