| CTRI Number |
CTRI/2024/11/076817 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Sensory-motor training on hand and upper extremity sensory and motor function in patients weith Parkinsons Disease |
|
Scientific Title of Study
|
The effect of sensory-motor training on hand and upper extremity sensory and motor function in patients with Parkinson Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Grisha Kudaskar |
| Designation |
2nd Year Master of Occupational Therapy in Neuroscience |
| Affiliation |
Goa Medical College Bambolim Goa India 403202 |
| Address |
OPD 17 Department of Occupational Therapy Goa Medical College Bambolim Goa India 403202
North Goa
GOA
403202
India |
| Phone |
8390889462 |
| Fax |
|
| Email |
grishakudaskar3007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Vajaratkar |
| Designation |
Associate Professor in Occupational Therapy |
| Affiliation |
Goa Medical College |
| Address |
Department of Orthopedic Goa Medical College Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9730948392 |
| Fax |
|
| Email |
vivekvajaratkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Vajaratkar |
| Designation |
Associate Professor in Occupational Therapy |
| Affiliation |
Goa Medical College |
| Address |
Department of Orthopedic Goa Medical College Bambolim Goa
North Goa
GOA
403202
India |
| Phone |
9730948392 |
| Fax |
|
| Email |
vivekvajaratkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital Bambolim Goa India 403202 |
|
|
Primary Sponsor
|
| Name |
Grisha Kudaskar |
| Address |
Goa Medical College and Hospital Bambolim Goa India 403202 |
| 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 Grisha Kudaskar |
Goa Medical College and Hospital |
OPD 17 Department of Occupational Therapy Departement of Neurology Bambolim North Goa India 403202
North Goa
GOA |
8390889462
grishakudaskar3007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Lois James Samuel |
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 |
Control Therapy |
activities to improve fine motor ans sensory function such as rubbing of different textures on the hands such as silk, cotton etc
transfer of water bottle from one place to the other
separation of grains
making different shapes of clay
nut bolt activity
identification of different temperature
It will take 5 days each week for 2 weeks each session lasting for 1 hour |
| Intervention |
Sensory Motor Training |
1. Sort weighted eggs or balloons (1, 2, or 3 oz).
Separate plastic ice cubes based on different temperatures.
2. Place hands and fingers in an immersion bath and differentiate the temperature based on 3 temperatures (warm, cold, and medium).
3. Select hot pack/cold pack based on different temperatures.
4. Texture dowels and fabric texture discrimination: Match the texture of the fabric on the table with the texture attached to the wood parts behind the curtain.
5. Textured pegboard and pegs: Match pegs behind the curtain with the pegboard in front of your eyes in terms of fabric.
6. Hide the beans inside the therapeutic putty and then find the beans while behind the curtain.
7. Clay modeling: Create a shape with clay. Discover the shape while behind the curtain by touching and make the same shape on the table.
8. LEGO rebuilding: After the therapist creates a shape with the blocks behind the curtain, manipulate it and then make a similar look in front of the curtain.
9. Stereognosis: After familiar objects are placed behind the curtain, discover them through touch and manipulation.
10. Match the dominoes on the table with the hidden dominoes in the bag.
11. Magnetic letters/wooden alphabet blocks/geometric puzzle pieces/ puzzle edges/different shapes/Perfection game pieces: Find and pull pieces out of the bag and place them in their proper places on the boards. Manipulate pieces as instructed to spell words, complete a puzzle, identify shapes, and compete other tasks.
12. Stone/bean/coin sorting: Retrieve items of different sizes from a bag and match the size that has been placed on the table.
13. Bottle caps: After bottles of different sizes are placed behind the curtain, remove the caps of each from the front and place them behind the curtain.
14. Nuts and bolts: After a plate of bolts in different sizes is placed behind the curtain, choose through touch and attach the same size nut from the front of the curtain.
This treatment will take 5 days each week for 2 weeks each session will last for 1 hour
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Mini-mental state examination score ≥23
2.Should be diagnosed according to Hoehn and Yahr Scale level between 1-3
3.No other neurological disorder, diabetes, or pain during tests
4.Both male and female can be included
|
|
| ExclusionCriteria |
| Details |
1.Cognitive deficits
2.Hand Contractures and deformities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Moving 2point discrimination test
2.Wrist proprioception sensation test
3.Weinstein enhanced sensory test
4.Hand active sensation test
5.Purdue pegboard test
6.Box and block test |
1.2 weeks
2.2 weeks
3.2 weeks
4.2 weeks
5.2 weeks
6.2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Haptic object recognition test |
1.2 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/12/2024 |
| 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 Yet Recruiting |
| 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
|
This is a quasi experimental study. Study will be conducted in tertiary hospital Goa Medical College. this study aims to investigate the effect of sensory motor training on hand and upper extremity sensory and motor function in patients with Parkinson’s Disease. |