| CTRI Number |
CTRI/2026/01/102562 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Problems faced by patients with spinal cord injury to take physiotherapy when living at home in Karnataka |
|
Scientific Title of Study
|
Barriers for Physiotherapy access among people with spinal cord injury at community level in Karnataka A Cross Sectional survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoomika Pachappa |
| Designation |
Post graduate student |
| Affiliation |
Manipal academy of higher education |
| Address |
Upper Basement Department of Physiotherapy Manipal Hospital No 98 Rustam Bagh Old Airport Road
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
8660072463 |
| Fax |
|
| Email |
bhoomika.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Physiotherapy, Manipal Hospital
#98, HAL, Old Airport Road, Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunima Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Physiotherapy, Manipal Hospital
#98, HAL, Old Airport Road, Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunima.biswas@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL, Old Airport Road, Bangalore
KARNATAKA 560017 India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL, Old Airport Road, Bangalore KARNATAKA 560017 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bhoomika Pachappa |
K.H.Patil institute of medical sciences |
Department of Internal medicine, room number 305 to 313, Mulagunda Road, Mallasamudra,Gadag-582103, Karnataka, India
Gadag
KARNATAKA |
8660072463
bhoomika.mhsblr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Spinal cord injury patients residing in Karnataka, All levels of injury, Traumatic type of injury, Moderate to complete level of dependence, Community dwelling SCI patients |
|
| ExclusionCriteria |
| Details |
Subjects with Cognitive dysfunction, Subjects who are in an institutional set up undergoing rehabilitation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Self structured questionnaire |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2026 |
| Date of Study Completion (India) |
23/04/2026 |
| 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
|
A self-structured Likert-based questionnaire will be developed through a review of literature identifying barriers faced by individuals with spinal cord injury. Relevant domains will be selected and items formulated, which will be reviewed by two neurorehabilitation experts with a minimum of 10 years of experience. The questionnaire will then undergo validation using a structured validation form consisting of item description, rating, and comments. Validation will be performed by five neurorehabilitation physiotherapists using a 3-point Likert scale (1 = not relevant, 2 = relevant with minor modification, 3 = very relevant). Inter-rater reliability will be assessed using the kappa statistic; if acceptable reliability is not achieved, the questionnaire will be revised and revalidated. Following validation, participants will be recruited through the Association of Physically Disabled (APD) and community camps in Karnataka. The questionnaire will be administered as an interview in the participant’s preferred language, assessing health education, treatment, health staff, and personal barriers. Data analysis will then be performed. |