| CTRI Number |
CTRI/2024/05/066819 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Effect of Expressive Art Training and Traditional Exercises on Parkinsons Patient for Hand Usage and Well Being using Jebsen Taylor Hand Function and Parkinson’s disease Quality of Life Questionnaire. |
|
Scientific Title of Study
|
Effectiveness Of Expressive Art Therapy Along with Conventional Therapy on Hand
Function and Quality of Life in Persons with Parkinson’s. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishika Jaiswal |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy - Department of Neuro Physiotherapy 11/12,Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9404296622 |
| Fax |
|
| Email |
ishikavaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Bhattad |
| Designation |
Professor and HOD of Neuro Physiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy - Department of Neuro Physiotherapy 11/12,Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9860542511 |
| Fax |
|
| Email |
drradhabhattad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Bhattad |
| Designation |
Professor and HOD of Neuro Physiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy - Department of Neuro Physiotherapy 11/12,Thube Park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9860542511 |
| Fax |
|
| Email |
drradhabhattad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy - Neuro Physiotherapy Department 11/12,Thube Park, Shivaji Nagar, Pune MAHARASHTRA
411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12,Thube Park, Shivaji Nagar, Pune MAHARASHTRA
411005 |
| 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 |
| Dr Ishika Jaiswal |
Sancheti Institute for Orthopaedics and Rehabilitation |
1st floor - Department of Neuro Physiotherapy Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA |
9404296622
ishikavaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopedics and Rehabilitation Institutional Ethics Committee |
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 |
| Intervention |
Expressive Art Therapy along with Conventional Therapy. |
The Intervention will include 6 types of art therapies which will be given for 1 week each along with conventional therapy for 1 hour per session
for 6 weeks having 3 session per week. |
| Comparator Agent |
NIL
|
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Modified Hoehn and Yahr stage 2 to 4.
2) Mild (score 20-25) to Moderate (score 10-19) Cognition impairment on Mini mental status examination (MMSE) scale. |
|
| ExclusionCriteria |
| Details |
1) Any other associated Neurological conditions.
2) Uncorrected Visual and hearing impairments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Parkinson’s disease Quality of Life Questionnaire |
At baseline (0 weeks) & after intervention (after 6
weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2 Jebsen Taylor Hand Function test .
3 Michigan Hand Function
Questionnaire . |
At baseline (0 weeks) & after intervention (after 6
weeks) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/05/2024 |
| Date of Study Completion (India) |
14/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
• Hand function impairment in Parkinson’s disease can significantly impact Activities of Daily Living (ADL) and overall quality of life. Fine motor skills are compromised. This can lead to increased dependence on others for daily activities. • Moreover, decreased hand function can contribute to difficulties in tasks involving coordination and precision, potentially leading to frustration and reduced participation in social and recreational activities. • Expressive arts therapy is a therapeutic practice that uses a variety of art forms. It can help people deal with emotional conflicts, develop self-awareness, and manage behavior. • It goes beyond verbal communication, allowing participants to convey feelings through creative processes like drawing, painting, sculpture and more. • The Expressive Art therapy is used more in geriatric population and limited in Parkinson’s patients but they have similar limitations in ADL’s so this study explores more to it. |