| CTRI Number |
CTRI/2017/03/008271 [Registered on: 31/03/2017] Trial Registered Prospectively |
| Last Modified On: |
24/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Benefits of Physical Activity of Daily Functioning on Movement and Cognitive Ability in People with Parkinsons Disease. |
|
Scientific Title of Study
|
Effect of Physical Activity on Motor and Cognitive Function in Parkinsons Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Yukti Gogia |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences (SOAHS),
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9873016978 |
| Fax |
|
| Email |
yuktigogia92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Karthik Babu |
| Designation |
Assoc. Professor |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences (SOAHS),
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Divya Mohan |
| Designation |
Asst. Professor- Senior Scale |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences (SOAHS),
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA
560017
India |
| Phone |
9886794027 |
| Fax |
|
| Email |
dimspt2002@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| School of Allied Health Sciences (SOAHS),
A Constituent Institute of Manipal University,
Manipal Hospital,
HAL Airport Road,
Bangalore.
|
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal University |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences (SOAHS),
Manipal Hospital,
HAL Airport Road,
Bangalore.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ms Yukti Gogia |
Manipal Hospital |
Department of Physiotherapy,
School of Allied Health Sciences (SOAHS),
A Constituent Institute of Manipal University,
Manipal Hospital,
HAL Airport Road,
Bangalore.
Bangalore
KARNATAKA |
9902338198
karthikbabu78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Parkinsons Disease , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
None |
| Intervention |
Physical activity involving daily functional tasks. |
Physical activity emphasizes the activities of trunk and extremities movements during tasks such as sit-stand, stair climbing and weight shift in functional sitting and standing positions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) According to modified HOEHN and YAHR grading 2 to 4
2) Able to understand verbal commands and able to respond to it
3) Able to stand independently with supervison |
|
| ExclusionCriteria |
| Details |
1) Recent musculoskeltal injuries of shoulders or hips and knees.
2) Recent Myocardial Infarction
3) Medically unstable |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Addenbrookes cognitive Examination (ACE) tool
2) UPDRS |
2 time points
Pre intervention and 6-week post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Short test of musical preference (STOMP) scale
2) GPAQ scale
3) Functional reach test
4) ABC scale
5) Timed up and go test
6) Fall efficacy scale |
Two time points
Pre intervention and 6-week post intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
03/04/2017 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is aimed to examine the physical activity on motor and cognitive function in people with Parkinson’s disease. |