| CTRI Number |
CTRI/2017/11/010466 [Registered on: 13/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Through the continuity of a course of Art Therapy, the brain is stimulated, allowing past memories to resurface, cognitive ability to develop and new memories to form |
|
Scientific Title of Study
|
Effects of Art therapy on Cognitive functions among Stroke survivors |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MERCY RUSSELIN PRABHA R |
| Designation |
Associate professor |
| Affiliation |
NIMS College of Nursing |
| Address |
NIMS College of Nursing
NIMS Medicity
Aralumoodu,
Neyyattinkara.
Thiruvananthapuram dist.
NIMS Medicity
Aralumoodu,
Neyyattinkara.
Thiruvananthapuram
KERALA
695123
India |
| Phone |
9443152247 |
| Fax |
|
| Email |
russelinprabha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MERCY RUSSELIN PRABHA R |
| Designation |
Associate professor |
| Affiliation |
NIMS College of Nursing |
| Address |
NIMS College of Nursing
NIMS Medicity
Aralumoodu,
Neyyattinkara.
Thiruvananthapuram dist.
NIMS Medicity
Aralumoodu,
Neyyattinkara.
Thiruvananthapuram
KERALA
695123
India |
| Phone |
9443152247 |
| Fax |
|
| Email |
russelinprabha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRAJASEKHARAN |
| Designation |
Professor |
| Affiliation |
Government Medical College |
| Address |
Government Medical College ,
Thiruvananthapuram.
Professor of Medicine,
Government Medical College ,
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447024003 |
| Fax |
|
| Email |
rajasekharanchandrasekharan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MERCY RUSSELIN PRABHA R |
| Address |
NIMS College of Nursing, Aralumoodu, Neyyattinkara, Thiruvananthapuram, Kerala. |
| Type of Sponsor |
Other [Researcher will meet all expenses.] |
|
|
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 |
| RMercy Russelin Prabha |
Government Medical College |
Physical Medicine and Rehabilitation centre, Neurology department,Government Medical College, Thiruvananthapuram.
Thiruvananthapuram
KERALA |
9443152247
russelinprabha@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt.Medical College, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, Stroke survivors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Art therapy |
1..Write name, place, date, month, year and contact number daily.
2.Count and write images
3.Make the person to repeat the address 3 times
4.Identifying difference between two pictures.
5.Addition and subtraction of numbers
6Give an alphabet and ask to produce words as many as possible.
7.Labeling different pictures.
8.Obey simple commands and do the activities.
9.Repetition of words and phrases.
10.Ask to read some sentences and tell to show some words/letters.
11.Make up a sentence and write it down in the space below
12.Copy the figures/shape given in the book
13.Draw a clock-face with all the numbers and the hands at different timings
14.Connect dots and make images.
15.Colouring different pictures.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stroke survivors with the ability to extend the meta carpo phalangeal and inter phalangeal joints at least 10degree and actively extend the wrist at least 20 degree. |
|
| ExclusionCriteria |
| Details |
1. Major medical problems and neuropathies.
2. Unwilling patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased cognitive function |
Each sample will receive Art therapy(intervention)for a period of one month. The outcome of intervention will be measured after one month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in daily functions. |
100 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/12/2017 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Publications details of researcher
1.National Workshop- NIMS 30.04.13Role of Nurse in Health Promotion
2.National Workshop- NIMS 26.04.15 Poisoning
3.Nursing Journal of India April Issue 2013 Effects of structured teaching program on prevention of uterine and cervical cancer
4.Nursing Journal of India - June Issue 2014 Team work and collaborative patient care
5.Text Book December 2015 Neurology for Professional Nurses
Author : R.Mercy Russelin Prabha
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study title was changed and registered as new trial.
|