| CTRI Number |
CTRI/2022/08/044682 [Registered on: 05/08/2022] Trial Registered Prospectively |
| Last Modified On: |
04/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Health related quality of life of Spinal cord injury patients. |
|
Scientific Title of Study
|
A cross sectional study of health related quality of life of patients with spinal cord injury in different rehabilitation stages. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DILAR AMITKUMAR RANA |
| Designation |
TUTOR CUM PHYSIOTHERAPIST |
| Affiliation |
Government spine Institute and Government Physiotherapy college |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY, PARUL UNIVERSITY, POST LIMDA, WAGHODIA, GUJARAT
391760
AND AHMEDABAD GUJARAT
Government spine Institute and Government Physiotherapy college
civil hospital campus, Asarwa,
Ahmadabad, Gujarat 380016
Ahmadabad
GUJARAT
391760
India |
| Phone |
9998472501 |
| Fax |
|
| Email |
dr.dilar@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmalkumar Bhattacharya |
| Designation |
Proffesor and Head, Department of General Medicine |
| Affiliation |
Parul institute of Medical Sciences and Research, Parul University |
| Address |
Parul institute of Medical Sciences and Research, Parul University, POST LIMDA, WAGHODIA, GUJARAT
391760
Parul institute of Medical Sciences and Research, Parul University, POST LIMDA, WAGHODIA, GUJARAT
391760
Vadodara
GUJARAT
380015
India |
| Phone |
9824333430 |
| Fax |
|
| Email |
amal_akb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DILAR AMITKUMAR RANA |
| Designation |
TUTOR CUM PHYSIOTHERAPIST |
| Affiliation |
Government spine Institute and Government Physiotherapy college |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY, PARUL UNIVERSITY, POST LIMDA, WAGHODIA, GUJARAT
391760
AND AHMEDABAD GUJARAT
Government spine Institute and Government Physiotherapy college
civil hospital campus, Asarwa,
Ahmadabad, Gujarat 380016
GUJARAT
391760
India |
| Phone |
9998472501 |
| Fax |
|
| Email |
dr.dilar@gmai.com |
|
|
Source of Monetary or Material Support
|
| SPINE MEICUS,
AXON SPINE CENTER,
PUSHYA HOSPITAL,
CONCEPT NEURO AND SPINECARE HOSPITAL, |
|
|
Primary Sponsor
|
| Name |
DR DILAR AMITKUMAR RANA |
| Address |
B 503 VASUPUJYA FLAT,OPP.ISKCON TEMPLE, NR.COURTYARD MARRIOTT HOTEL,SATELLITE, AHMADABAD,GUJARAT 380015 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HARSHIL PATEL MS SPINE SURGEON |
AXON SPINE CENTRE |
A/53 AXON SPINE CENTRE,FIRST FLOOR AMRAPALI SHOPPING MALL, NR.D MART, AMBLI BOPAL CROSS ROADS, BOPAL, AHMEDABAD 380058
Ahmadabad
GUJARAT |
7069979988
Drhrp.1022@gmail.com |
| DR PARIMAL TRIPATHI |
CONCEPT NEURO AND SPINECARE HOSPITAL |
402 to 404 SHITAL VARSHA, SHIVRANJANI CROSS ROAD AHMEDABAD 380015
Ahmadabad
GUJARAT |
8889399840
cnshospital2013@gmail.com |
| DR VIRAL SHAH SPINE SURGEON |
PUSHYA HOSPITAL |
32,pushya Hospital for spine SARDAR PATEL NAGER, OPP.ABC 1, NR.WAGH BAKRI TEA LOUNGE, NAVRANGPURA, AHMEDABAD 380009
Ahmadabad
GUJARAT |
9904989966
pushyahospital@gmail.com |
| DR MAYUR VALA MS SPINE SURGEON |
SPINE MEDICUS |
301,Spine medicus, shitalvarsha5 opp.tanishq showroom, shivrangani cross road, satellite Ahmedabad 380015
Ahmadabad
GUJARAT |
8347450399
mayurgvala@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SANGINI HOSPITAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Persons with Traumatic and non traumatic both SCI
Patients with ASIA grade A,B,C,D both complete and incomplete injury
Pressure sore ulcer grade 1 and 2
Conservative and operated
|
|
| ExclusionCriteria |
| Details |
Difficulty to understand Gujarat, Hindi and English
Known psychiatric problem
Known progressive disease
Completely ambulatory person
Person completely depend on an electric wheelchair
Other musculoskeletal conditions like fracture
Pressure sore grade 3 and 4
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Manual Muscle Testing
2) American Spinal Cord Injury Association-ASIA
3) Spinal Cord Independence Measures III- SCIM III
4) who quality of life bref
5) Walking index of spinal cord injury II-WISCI II
|
4 TO 8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Manual Muscle Testing
2) American Spinal Cord Injury Association-ASIA
3) Spinal Cord Independence Measures III- SCIM III
4) who quality of life bref
5) Walking index of spinal cord injury II-WISCI II
|
10 TO 12 WEEKS
36 TO 40 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
22/08/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET AVAILABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in its function. Symptoms may include loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cord below the level of the injury, thereby affecting the spinal cords ability to send and receive messages from the brain to the body’s systems that control sensory, motor and autonomic function below the level of injury. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), commonly referred to as the ASIA Exam, was developed by the American Spinal Injury Association (ASIA) as a universal classification tool for Spinal Cord Injury based on a standardized sensory and motor assessment, with the most recent revised edition published in 2011. Spinal cord injury (SCI) typically results in impaired motion and loss of function, both of which are associated with a decrease in quality of life Rehabilitation interventions that promote recovery of lost function through the implementation of compensatory techniques and equipment have been positively correlated with improvements in quality of life for persons with SCI (2) . Quality-of-life scores remain significantly below the level observed in similar populations without SCI. In a study by Kannisto et al (3), for example, individuals with SCI showed quality-of life scores nearly 10% below those recorded for healthy adults. In initial stage patient is in spinal shock. Initial Medical care are most important for making patient more stable and prognosis. In stage I, rehabilatation program starts to prevent complications and to maintain musculoskeletal properties and to enhance neurology. In stage II, active rehabitalation is performed by rehab team and patient is trained for further physical activity, transfer and selfcare with all activity of daily livings. In stage III, after discharge home based and out patient department rehabilitation protocol is facilitated and practieced. (24) Medical management of SCI is designed first to save lives and second to minimize the consequences of the trauma, thereby optimizing the conditions for long-term survival with a good QL (Quality of life). With improved medical care the number of SCI survivors grows, thus making the need for better knowledge and understanding regarding subsequent disability and handicap more apparent. Quality of life is generally lower among the SCI than in the general population. HRQoL is measure in intial stage, at time of discharge and after discharge in follow up . • STAGE I: INITIAL ASSESSMENT AND INTERVIEW- WITHIN 2WEEKS • STAGE II: AT TIME OF DISCHARGE- 10- 12 WEEKS ( 2-3 MONTHS ) • STAGE III:FOLOW UP IN OPD - > 9 MONTHS AFTER DISCHARGE Participants will be invited for measurement session at the rehabilitation center where the Spinal Cord Independence Measure II (SCIM II), the Health related quality of life WHOQOL BREF , the Walking Index for Spinal Cord Injury II (WISCI), and the ASIA standard classification including the motor score (MS) were performed. During that visit, the number of falls the patient experiences during the previous 1 month will be recorded by interview.
From that visit onward, a 4-month prospective recording of the number of falls will be started using a specifically designed. HRQOL is subjective and value based ,involves the individuals’ perception of both positive and negative in physical health, psychological health, social and environmental -dimensions. As healthcare has improved, life expectancy following spinal cord injury (SCI) has increased. Spinal cord injured patients treated and followed in specialized units now have an almost normal life expectancy.1,6 Living with disability therefore becomes a life-long process for many injured persons, with a different set of problems presenting themselves at different stages in life.
We can analysis barrier and facilitator to such disable who living with spinal cord injury and improve their quality of life.
|