| CTRI Number |
CTRI/2024/03/064549 [Registered on: 20/03/2024] 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, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two treatment strategies, neurofeedback EEG training and virtual reality with body weight supported treadmill training in subjects with incomplete spinal cord injury |
|
Scientific Title of Study
|
Efficacy of Neurofeedback EEG training before virtual reality enhanced partial body weight supported treadmill training in improving neuropsychological status, balance and quality of life in incomplete spinal cord injury-A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shanika Sharma |
| Designation |
Assistant Professor, PhD scholor, Lovely Professional University, Jalandhar. |
| Affiliation |
Lovely Professional University, Phagwara |
| Address |
Block 4, Room no.213, Department of Physiotherapy, School of Allied Medical Sciences,Lovely Professional University, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India |
| Phone |
7018955885 |
| Fax |
|
| Email |
sharmashanika19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varun Kalia PhD |
| Designation |
Assistant Professor, Lovely Professional University, Jalandhar. |
| Affiliation |
Lovely Professional University, Phagwara |
| Address |
Block no. 4, Room no.213, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India |
| Phone |
8360374990 |
| Fax |
|
| Email |
varun.26576@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shanika Sharma |
| Designation |
Assistant Professor, PhD scholor, Lovely Professional University, Jalandhar. |
| Affiliation |
Lovely Professional University, Phagwara |
| Address |
Block 4, Room no.213, Department of Physiotherapy, School of Allied Medical Sciences,Lovely Professional University, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India |
| Phone |
7018955885 |
| Fax |
|
| Email |
sharmashanika19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurjot Spinal Rehab & Physiotherapy clinic, Urban Estate, Phase II, Jalandhar |
| Physiotherapy OPD, Department of Physiotherapy, Lovely Professional University, Phagwara |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara-India |
| Type of Sponsor |
Other [Private University] |
|
|
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 Varun Kalia |
Lovely Professional University |
Block no. 3, Room no. 105,Physiotherapy OPD, Department of Physiotherapy, School of Allied Medical Sciences
Jalandhar
PUNJAB |
8360374990
varun.26576@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Active control group (Group 3): Subjects of will be treated with conventional physiotherapy for 12 weeks
(3 days alternatively per week)
|
| Intervention |
Neurofeedback-EEG training
Conventional Physiotherapy |
Intervention Group 2: Subjects will be treated with NF-EEG training prior to conventional physiotherapy for 12 weeks (3 days alternatively per week) |
| Intervention |
Neurofeedback-EEG training
Virtual Reality enhanced body weight supported treadmil training
Conventional Physiotherapy |
Intervention Group 1: Subjects will undergo NF- EEG training prior to gait rehabilitation using virtual reality enhanced partial body weight supported treadmill training along with conventional physiotherapy for12 weeks (3 days alternatively per week) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group of 20-40 years.
2. Both male and female.
3. Subjects who will be willing to participate in the study.
4. Subjects with traumatic incomplete SCI.
5. Subjects with Incomplete SCI; ASIA C and ASIA D as per ASIA impairment scale.
6. Subjects with a level of injury at or below the sixth thoracic (T6) vertebrae with preserved trunk balance in the sitting (Sitting Balance Measure scale will be used).
7. Subjects with spasticity Grade ≤ 2 on the Modified Ashworth scale.
8. Duration of injury shall be ≥3 months.
|
|
| ExclusionCriteria |
| Details |
1. Subjects having paraplegia because of myelopathy or any other space-occupying lesion.
2. Subjects with Pressure sores will be excluded.
3. Subjects who any have fixed deformity of the lower limb will be excluded.
4. Subjects who are not able to understand the commands of the therapist, having marked visual and hearing impairment, with other medical conditions like Autoimmune disease, and with other neurological disorder, e.g., stroke, Parkinson’s disease, multiple sclerosis, Leprosy/skin disease will be excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Walking index for Spinal Cord Injury (WISCI)-II
2. Berg Balance Scale (BBS)
3. Swaymeter
4. Beck Depression inventory
5. State-trait anxiety inventory
|
Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Modified Ashworth Scale (MAS)
2. ASIA impairment scale
3. WHOQOL-BREF-participation
|
Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2024 |
| 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="2"
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
|
The present study is a single-blinded, three-arm parallel-group randomized clinical
trial which will include a total of 60 subjects
diagnosed with incomplete spinal cord injury,
(15% dropouts) will be selected based on inclusion criteria. The
primary objective of the study is to evaluate the effectiveness of
NF-EEG training before virtual reality enhanced partial body weight supported treadmill training and conventional physiotherapy in improving neuropsychological status, static
& dynamic standing
balance, walking index and
quality of life in subjects with
incomplete spinal cord injury. Before initiation of the study, subjects will be
explained the purpose and procedure of the study. Thereafter written informed
consent will be obtained from each subject and will undergo pre- intervention
assessment by using Walking index for Spinal Cord Injury
(WISCI)-II, Berg Balance
Scale (BBS), Swaymeter, Beck Depression inventory and
State-trait anxiety inventory, Modified Ashworth Scale (MAS), ASIA impairment scale and WHOQOL-BREF-participation. Afterwards, they will be randomly allocated into three groups:
Group 1 (NF-EEG training
prior to Virtual
reality and conventional physiotherapy), Group 2 (NF-
EEG training prior to conventional physiotherapy) and Group 3 (Conventional
physiotherapy). Thereafter subjects
of Group 1 (n=20) will undergo NF-EEG
training prior to gait rehabilitation using virtual reality
enhanced partial body weight supported
treadmill training along with conventional physiotherapy. Whereas, Group
2 (n=20) will be treated with NF-EEG training
prior to conventional physiotherapy. Subjects of Group 3 (n=20) will be treated with conventional physiotherapy only. Balance and Gait rehabilitation using virtual reality
will be given for 30 minutes. Conventional physiotherapy protocol will also
be followed for 40 minutes. The intervention
will be given for three days a week on alternative days, for 12 weeks to all the
subjects. After 12 weeks, post-intervention
assessment will be done using same
outcome measures as on first day.
|