| CTRI Number |
CTRI/2024/12/078614 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of group circuit training and task oriented training on upper extremity functions in individuals with spinal cord injury. |
|
Scientific Title of Study
|
A comparative study of group circuit training and task oriented training on upper extremity functions in individuals with 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 |
Dwija Jadon |
| Designation |
Postgraduate student (Masters in Occupational Therapy) |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre -Institute of Rehabilitation Sciences , Sec -C, Vasant Kunj, Delhi -110070
South West Delhi
110070
India
South West
DELHI
110070
India |
| Phone |
9821180782 |
| Fax |
|
| Email |
jadondwija99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor, Occupational Therapy |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre -Institute of Rehabilitation Sciences , Sec -C, Vasant Kunj, Delhi -110070
South West Delhi
110070
India
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor, Occupational Therapy |
| Affiliation |
ISIC Institute of Rehabilitation Sciences |
| Address |
Second floor, Indian Spinal Injuries Centre -Institute of Rehabilitation Sciences , Sec -C, Vasant Kunj, Delhi -110070
South West Delhi
110070
India
South West
DELHI
110070
India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre -Institute of Rehabilitation
Sciences, Sec -C , Vasant Kunj, Delhi-110070 South West Delhi 110070 India |
|
|
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 |
| Ms Lipika Malik |
ISIC Hospital |
Second floor, Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences , Sec-C, Vasant Kunj , Delhi -110070
South West Delhi 110070
India
South West
DELHI |
9999931199
lipika.otist@gmail.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: G958||Other specified diseases of spinalcord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP CIRCUIT TRAINING |
Thera-putty
Skate
Sanding board
Stacking cylindrical pegs
Wrist roller
Pronation and Supination board.
Intervention will be given for 5 sessions in a week for total 4 weeks . Each session will be of 30 minutes. |
| Comparator Agent |
NA |
NA |
| Intervention |
TASK ORIENTED TRAINING |
Eating with the spoon
Drinking water from a cup
Combing hair
Polishing table with a towel
Zipping on ADL board
Intervention will be given for 5 sessions in a week for total 4 weeks . Each session will be of 30 minutes.
Folding hand towel |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged at 18 years or above.
Both male and female
Both traumatic and non-traumatic spinal cord injury.
Level of Injury C5 to C7 level
Duration of injury 1 to 6 months post spinal cord injury.
Voluntary thumb movement |
|
| ExclusionCriteria |
| Details |
Diagnosed with any psychiatric illness.
Diagnosed with any other neurological condition.
Diagnosed with any orthopedic condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Capabilities of Upper Extremity Questionaire English and Hindi |
Baseline - 0 weeks , Post intervention-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
06/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
- Spinal cord injury is characterized by neurological deficits that lead to problems such as cognitive, motor, sensory, and emotional disorders. Group circuit training is an intervention in which a small group of individuals perform motor tasks on different workstations. This provides an opportunity to enhance social interaction and motivation. Task-oriented training is a motor learning-based intervention and involves daily life activities. In this study, the participants will be taken from Indian Spinal Injuries Centre , Vasant Kunj. Participants will be selected based on inclusion criteria. The study design will be experimental and the total sample size is 24. Participants will then be divided into two groups (Group - A and Group -B) i.e 12 participants in each group. Group -A will receive group circuit training and conventional therapy and Group – B will receive task-oriented training and conventional therapy. The training program will be given for 30 minutes, 5 times a week for 4 weeks.
|