| CTRI Number |
CTRI/2024/03/064081 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is about the efficacy of training  patients with spinal cord injuries in multidirectional reach  aiming for unsupported sitting balance |
|
Scientific Title of Study
|
Effectiveness of Multi-Directional Reach Training For Unsupported Sitting Balance 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 |
Shweta Singh |
| Designation |
PG Student |
| Affiliation |
Indian Spinal Injury Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant Kunj South Delhi,
South West
DELHI
110070
India |
| Phone |
9953857578 |
| Fax |
|
| Email |
isicshsingh66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Megha Nijhawan |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injury Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant Kunj South Delhi,
South West
DELHI
110070
India |
| Phone |
8802021752 |
| Fax |
|
| Email |
physiomegha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Megha Nijhawan |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injury Centre - Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant Kunj South Delhi,
South West
DELHI
110070
India |
| Phone |
8802021752 |
| Fax |
|
| Email |
physiomegha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injury Centre, Institute of Rehabilitation Sciences,Sector C Vasant Kunj ,New Delhi -110070 |
|
|
Primary Sponsor
|
| Name |
Dr. Megha Nijhawan |
| Address |
Indian Spinal Injury Centre- Institute of Rehabilitation Sciences, Sector- C Vasant Kunj, New Delhi -110070 Open |
| Type of Sponsor |
Other [Other (self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rajeev Aggarwal |
AIIMS, Ansari Nagar , New Delhi - 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Singh |
Indian Spinal Injury Centre |
Indian Spinal Injury Centre, Institute of Rehabilitation Sciences, Rehabilitation Department 2nd floor, Sector C, Vasant Kunj, South Delhi
South
DELHI |
9953857578
isicshsingh66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Centre - Institutional Ethics Committee |
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 |
| Comparator Agent |
Conventional Therapy |
Muscular strengthening for upper and lower extremities
Rolling over
Sitting up
Locomotion training
Standing for 30 minutes
Automated lower extremity cycling for 20 minutes. |
| Intervention |
Multi Directional Reach Training |
Multi Directional Reach Training will be given 5 sessions per week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with 18years-65 years of age.
Ability to sit for 1 hours without undue pain or muscle spasm.
Level of Injury C6-L1 . ASIA ( A, B, C & D )
Subjects with minimum 90 degree of shoulder flexion.
Individuals diagnosed with SCI for more than 3 months. |
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with any neurological/cognitive/orthopedic co-morbidities.
2. History of fainting or dizziness and/or on medications that causes dizziness or imbalance.
3. Serious complication related to SCI ( pressure sore, shortness of breath or significant increase in muscle tone and impaired blood pressure) that would interfere in balance training
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sitting Star Excursions Balance Test, Sitting Balance Scale, prokin - techno body sitting balance |
on day 0 and after 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
22/03/2024 |
| 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 Yet Recruiting |
| 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 (SCI) can cause temporary or permanent changes in the spinal cord’s normal sensory-motor or autonomic functions. These changes may adversely affect an individual’s functional status and quality of life. Globally, around 2,50,000 – 5,00,000 individual suffer from spinal cord injury (SCI). Trunk stability is the third most important goal in rehabilitation of people with spinal cord injury. Sitting is one of the most fundamental activities of daily living for persons with SCI and this ability determines their level of independence for many activities of daily living. This research is about the effectiveness of multi – directional reach training for unsupported sitting balance in individuals with spinal cord injury. The purpose of this study is to determine the effect of multi- directional reach training for unsupported sitting balance in spinal cord injury patients. Patients will be selected on the basis of inclusion and exclusion criteria. They will be divided into 2 groups with the help of randomization software. One group will receive Multi – Directional Reach Training for 30 minutes, 3 times a week for 4 weeks. The other group which is the conventional group will receive conventional therapy only. The outcome measurements will be done by FIST – SCI for specific functional task in sitting and Pro-kin Techno Body Sitting Balance (Star Test) for sitting balance. The changes in the pre and post outcome measure will help us to find out how much Multi – Directional Reach Training is effective in improving the sitting balance and specific functional task in sitting in individuals with spinal cord injury. |