| CTRI Number |
CTRI/2022/09/045762 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effect of blended exercise program on rigidity score among Parkinson’s Disease patients attending Neuro OPD at AIIMS, New Delhi. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the effect of blended exercise program on rigidity score among Parkinson’s Disease patients attending Neuro OPD at AIIMS, New Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REETIKA |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Dept.:-College Of Nursing,Old OT block,AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
7351958212 |
| Fax |
|
| Email |
reetikarajpura@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room No:-9,Dept.:-College Of Nursing,Old OT block, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no:-9,
Dept.:-College Of Nursing,
Old OT block
AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
COllege of Nursing, AIIMS, New Delhi,110029 |
| 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 |
| REETIKA |
AIIMS, NEW DELHI |
NEURO OPD, GROUND FLOOR, CNC BUILDING, AIIMS, NEW DELHI
South
DELHI |
7351958212
reetikarajpura@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCCIENCES |
Approved |
|
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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 |
| Intervention |
Blended exercise program |
A structured exercise program given to Parkinson Disease patients on a one to one basis with videos to be practiced at home for 6 weeks. |
| Comparator Agent |
Control group |
Standard treatment will be given to those in control group as per institutes protocol |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Parkinson’s Disease Patients attending Neurology OPD at AIIMS, New Delhi.
2. Patients who are willing to participate in the study.
3. Patients who are able to follow commands and instructions.
4. Patients with Parkinson’s Disease with Hoehn and Yahr stages 2.0,2.5 and 3.0
|
|
| ExclusionCriteria |
| Details |
• Parkinson’s Disease patients having a clinical diagnosis of dementia (using the Mini-Mental State Examination with a score _ 24/30).
• Parkinson’s Disease patients with any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems that could affect gait assessments.
• Parkinson’s disease patients with visual problems that could not be corrected with lenses or glasses.
• Patient with Parkinson’s Plus Syndrome.
• Patients who are not giving consent for the study.
• Patients who are not able to communicate in Hindi or English.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess rigidity scores of patients using unified Parkinson’s disease rating scale part III |
6weeks |
|
|
Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/09/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
publication will be done after results are generated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study:- The aim of this study is to study the effectiveness of blended Exercise Program on Rigidity Score of Parkinson’s Disease Patient. OBJECTIVES Primary objectives 1. To assess and compare the rigidity score among Parkinson’s Patients in both control and intervention group. 2.To assess the effectiveness of blended exercise program on rigidity scores of Parkinson’s patient in Intervention group . Secondary objectives To associate the baseline rigidity scores with selected demographic variables in both intervention and control group. HYPOTHESIS H1: There will be a significant difference in post test rigidity scores among Parkinson’s patients in control and Intervention group as measured by Unified Parkinson Disease Rating Scale motor score (Part III) at 0.05 level of significance. H2:- There will be a significant difference in the pre test and post test rigidity scores among Parkinson’s Patient in the Intervention group as measured by Unified Parkinson Disease Rating Scale motor score (Part III) at 0.05 level of significance.
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