| CTRI Number |
CTRI/2024/10/075968 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
a study on activities of daily living and functional reach in stroke survivors with upper limb sensory impairment |
|
Scientific Title of Study
|
Activities of daily living and functional reach among stroke survivors with upper extremity sensory impairment -
A descriptive study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima Taneesha |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy college, 6th floor, Naringana, Deralakatte,
Mangalore, Dakshina Kannada,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8136918968 |
| Fax |
|
| Email |
fathimatanisha1224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lourdhuraj I |
| Designation |
Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College,6th floor, Naringana, Deralakatte,
Mangalore, Dakshina Kannada,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lourdhuraj I |
| Designation |
Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College,6th floor, Naringana, Deralakatte,
Mangalore, Dakshina Kannada,
Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9940529169 |
| Fax |
|
| Email |
lourdhuraj@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College, 6th floor, Naringana, Deralakatte, Mangalore, Dakshina Kannada, Karnataka - 575018 |
|
|
Primary Sponsor
|
| Name |
Fathima Taneesha |
| Address |
Yenepoya Physiotherapy College,
Naringana, Derlakatte,
Mangalore - 575018
Karnataka. |
| 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 Lourdhuraj I |
Yenepoya Ayurveda Medical College Hospital ( Physiotherapy Department ), 4th floor |
Yenepoya Ayurveda Medical College Hospital ( Physiotherapy department, 4th floor ), Naringana, Deralakatte, Mangalore - 575018
Dakshina Kannada
KARNATAKA |
9940529169
lourdhuraj@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stroke patients with upper extremity sensory impairment.
Stroke patients without upper extremity sensory impairment.
Stroke patients with Brunnstrom stage 2 and more.
|
|
| ExclusionCriteria |
| Details |
Stroke patients with a history of neurologic conditions, Musculoskeletal condition,
cardiovascular condition,
Visual disorder.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified functional reach test (MFRT),
Barthel index. |
both outcome measure will be taken at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/11/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The descriptive study involving comparison of samples with or without upper extremity sensory impairment among stroke survivors, will be conducted to analyze activities of daily living and functional reach. The study will utilize the Barthel Index and the Modified functional reach test to gather and analyze data. This study aims to provide insights into the challenges nd capabilities of the stroke patients with upper extremity sensory impairment which can inform rehabilitation strategies and improve their Quality of life. |