| CTRI Number |
CTRI/2025/01/079250 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of providing psychological intervetion that is Cognitive Behavioral Therapy (CBT) for improving the psychological wellbeing of the participant along with the Activities of Daily Living Training required to perform daily routine activities on individuals wih Traumatic Tetraparesis |
|
Scientific Title of Study
|
Effect of combining Cognitive Behavioral Therapy (CBT) with Activities of Daily Living (ADL) Training in Traumatic Tetraparesis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Bisht |
| Designation |
Post Graduate Student (Masters of Occupational Therapy Neurology) |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences, Rehabilitation Department Second Floor Sector-C Vasant Kunj South Delhi
South
DELHI
110070
India |
| Phone |
8586995467 |
| Fax |
|
| Email |
riya1711bisht@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit Kumar Verma |
| Designation |
Professor |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences, Rehabilitation Department Second Floor Sector-C Vasant Kunj South Delhi
South
DELHI
110070
India |
| Phone |
9810625581 |
| Fax |
|
| Email |
ajitbudha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit Kumar Verma |
| Designation |
Professor |
| Affiliation |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Center- Institute of Rehabilitation Sciences, Rehabilitation Department Second Floor Sector-C Vasant Kunj South Delhi
South
DELHI
110070
India |
| Phone |
9810625581 |
| Fax |
|
| Email |
ajitbudha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Center- Institute of Rehabilitation Sciences,Department of Occupational Therapy,Second floor, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Ajit Kumar Verma |
PMR Department of Indian Spinal Injuries Centre |
Indian Spinal Injuries Centre, PMR Department, Ground floor, IAA Colony Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI |
09810625581
ajitbudha@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indian Spinal Injuries Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G825||Quadriplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavoral Therapy along with Activities of Daily Living Training |
Cognitive Behavoral Therapy will be provided for 10 minutes with Activities of Daily Living Training for 20 minutes for 5 sessions per week over the course of 4 weeks. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals from C5-C8 level of injury
Duration 6 or more than 6 months
Mode of injury- Traumatic
ASIA- B,C,D
STAI more than 20
undergooing rehabilitation therapy |
|
| ExclusionCriteria |
| Details |
Age less than 20 years old
Person with any other neurological and psychiatric condition
ASIA-A,E
Cord compression due to tumor, or degenerative diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
State Trait Anxiety Inventory
Spinal Cord Independance Measure III
|
Day 1 before intervention and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| American Spinal Injury Association(ASIA)Impairment Scale |
Day 1 before intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2025 |
| Date of Study Completion (India) |
03/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
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
|
Traumatic spinal
cord injury profoundly affects multiple dimensions of
a person’s psychological and social well-being. Cognitive Behavioral Therapy has a marked effect on
perception of control, self-perception, positive attitude towards the
disability, increased satisfaction with life, depression and anxiety in
individuals with spinal cord injury. It
involves learning new skills to manage symptoms. It also teaches new ways of
thinking and behaving that can help to get control over the anxiety in the
long-run. Occupational Therapy significantly improves Activity of
Daily Living (ADL) performance and self-care such as feeding, bathing, dressing
and grooming in complete tetraplegic spinal cord injury patients. Activity of
Daily Living (ADL) training helps patients to regain functional abilities by
teaching them how to adapt these tasks using assistive devices or modified
techniques. It enhances muscle strength, coordination, and cognitive awareness
of how to navigate daily life with their new physical limitations.
In
this study, the participants will be taken from Indian Spinal Injury Centre,
New Delhi and will be selected on the basis of inclusion criteria. Study Design
will be experimental and total Sample Size is 20. Participants will receive Cognitive Behavioral Therapy with Activity of Daily
Living (ADL) training The training programme will be given for 20
min, 5 times/week for 4 weeks in which they will be provided ADL training for fediing, dressing, grooming and mobility.
Pre intervention and
post intervention assessment will be done using ASIA, State trait
anxiety inventory for anxiety and Spinal cord independence measure III for independency in performing activities of daily living. Variations in the pre and post outcome meausre will help us to find out the effectiveness of the treatment. |