| CTRI Number |
CTRI/2022/10/046698 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
20/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between tiredness and daily activity participation in individuals who are paralyzed from lower body in India |
|
Scientific Title of Study
|
Correlation between fatigue and daily activity participation in individuals with paraplegia in the Indian context-A Cross Sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elvisia D Almeida |
| Designation |
Student of Masters of Occupational Therapy in Hand and Musculoskeletal Conditions |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy,3rd floor, Manipal College of Health Professions, MAHE, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008760368 |
| Fax |
|
| Email |
elvisia.almeida@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sridhar D |
| Designation |
Assistant Professor (Senior scale) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy,3rd floor, Manipal College of Health Professions, MAHE, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
09886216433 |
| Fax |
|
| Email |
sridhar.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Elvisia D Almeida |
| Designation |
Student of Masters of Occupational Therapy in Hand and Musculoskeletal Conditions |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy,3rd floor, Manipal College of Health Professions, MAHE, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9008760368 |
| Fax |
|
| Email |
elvisia.almeida@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Occupational Therapy, MCHP, MAHE |
|
|
Primary Sponsor
|
| Name |
Elvisia D Almeida |
| Address |
Department of Occupational Therapy,3rd floor, Manipal College of Health Professions, MAHE, Manipal-576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shyamasunder Bhat N |
Kasturba Hospital, Manipal |
Department of Orthopaedics, Ground floor OPD, Unit 1
Udupi
KARNATAKA |
9480486075
Shyambhat.n@manipal.edu |
| Mrs Rooplakshmi |
Sevabharathi Organization |
Udupi branch, Seva Nikethana,Sri Durga Parameshwari Temple, Herga
Udupi
KARNATAKA |
9964244785
executivedirector@sevaabharathi.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital |
Approved |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80-G83||Cerebral palsy and other paralytic syndromes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with paraplegia below the T10 level with 1-10 years of post-injury.
Individuals with paraplegia who can read and write either in English or Kannada.
Individuals with paraplegia aged 18 to 60. |
|
| ExclusionCriteria |
| Details |
Individuals with quadriplegia, as well as individuals with paraplegia with cognitive deficits and associated injuries (TBI, Recent fractures, progressive conditions). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fatigue Severity Scale(FSS) and
Impact on Participation and Autonomy Questionnaire (IPAQ) |
The study is a one time cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
28/10/2022 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
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: To study the impact of fatigue on daily activity participation in individuals with paraplegia in the Indian context.
Justification of the study: There are studies in western countries that may differ from those in India because of the context, facilities, how things are done differently in India, and how fatigue can impact can differ. There is a need to understand how fatigue affects individuals with paraplegia and how it impacts participation in daily activities in the Indian context. This
study could help to understand the severity of fatigue in individuals with
paraplegia and its relation to participation in daily activities in the Indian
context. This study could emphasize the need for screening these individuals
for fatigue-related issues in clinical and community settings. The findings of
the study could aid occupational therapists to give context-specific and client-centered
intervention for individuals with paraplegia.
|