| CTRI Number |
CTRI/2024/07/070454 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess cholesterol levels, Body Fat components, Bone Strength in participants with Spinal Cord Injury |
|
Scientific Title of Study
|
A Cross-Sectional Study to assess Lipid profile, Body Adiposity, Bone Mineral Density, Functional Status and Activity and Participation in Spinal Cord Injury |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Salwan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9781453349 |
| Fax |
|
| Email |
shubhamsalwan2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asem Rangita Chanu |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7598621688 |
| Fax |
|
| Email |
rangita8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Salwan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9781453349 |
| Fax |
|
| Email |
shubhamsalwan2@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi
Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi, India,
Pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Salwan |
| Address |
Physical Medicine and Rehabilitation, AIIMS New Delhi |
| 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 Shubham Salwan |
AIIMS New Delhi |
All India Institute of Medical Sciences, New Delhi, Sri Aurobindo Marg, Ansari Nagar East, Delhi
New Delhi
DELHI |
9781453349
shubhamsalwan2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, (2) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, (3) ICD-10 Condition: S241||Other and unspecified injuries ofthoracic spinal cord, (4) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord, (5) ICD-10 Condition: A180||Tuberculosis of bones and joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Admitted Spinal Cord Injury Patients to Physical Medicine and Rehabilitation ward (Traumatic and Non-Traumatic Spinal Cord Injury patients)
Duration of Injury- at least 3 months following Spinal Cord Injury
Patients who are capable of or willing to give informed consent
Patients comprehend English language |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactation
History of recent fracture in upper limb or lower limb
Clinical suspicion with radiological confirmation of Heterotopic Ossification
Patients with history of earlier bone loss like pagets disease, hyperparathyroidism, osteoporosis
Patients with history of Myocardial Infarction or Coronary Artery Disease
Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess High Density Lipoprotein-Cholesterol (HDL-c) levels in Spinal Cord Injury patients |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess other Lipid profile parameters {Low Density Lipoprotein-Cholesterol, Triglycerides, Total Cholesterol} in Spinal Cord Injury patients
2) To assess Body Composition parameters which are percentage total Body Fat Mass , Fat Mass Index, percentage trunk fat to percentage leg fat ratio, estimated Visceral Adipose Tissue volume, Lean Mass Index, Appendicular Lean Mass Index by using Dual Energy X-ray Absorptiometry scan in Spinal Cord Injury patients
3) To assess Bone Mineral Density at neck of femur & lower 1/3rd of forearm by using Dual Energy X-ray Absorptiometry scan in Spinal Cord Injury patients
4) To assess Functional Status in Spinal Cord Injury patients by using Self-Report version of Spinal Cord Independence Measure III
5) To assess Activity & Participation in Spinal Cord Injury patients by using International Spinal Cord Injury-Activities & Participation Basic Data Set (Version 1.0) |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
To assess Lipid profile, Body Adiposity, Bone Mineral Density, Functional Status and Activity and Participation in Spinal Cord Injury. It is a Cross-sectional Observational Study. High Density Lipoprotein Cholesterol (HDL-c) is taken as primary objective . Other Lipid parameters which are Low Density Lipoprotein Cholesterol (LDL-c), Triglycerides (TG) and Total Cholesterol (TC) are taken as secondary objective. Other secondary objectives like Body adiposity by measuring Body Composition parameters which are percentage Total Body Fat Mass (%FM), Fat Mass Index (FMI), percentage trunk fat to percentage leg fat ratio (%Trunk Fat/%Leg Fat), estimated Visceral Adipose Tissue volume (VAT volume), Lean Mass Index (LMI), Appendicular Lean Mass Index (ALMI) and Bone Mineral Density (BMD), both will be assessed by using DEXA scan; Functional status using Self-Report version of Spinal Cord Independence Measure III (SCIM-SR); Activity and participation using International Spinal Cord Injury-Activities and Participation Basic Data Set (Version 1.0) in Spinal Cord Injury patients. |