| CTRI Number |
CTRI/2024/11/076226 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Combined effect of Non- Invasive brain stimulation with treadmill gait training with virtual screen for improving muscle strength, balance of body and walking pattern of individuals with spinal cord injury |
|
Scientific Title of Study
|
Evaluation of synergistic effect of transcranial direct current stimulation with virtual reality assisted treadmill training for motor functions and quality of life of individuals with incomplete spinal cord injury : A Randomized controlled trail |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GARIMA WADHWA PT |
| Designation |
ASSISTANT PROFESSOR ISIC INSTITUTE OF REHABILITATION SCIENCES, PHD Scholar - SGT University |
| Affiliation |
ISIC INSTITUTE OF REHABILITATION SCIENCES |
| Address |
Indian Spinal injuries center, Department - Institute, Division - Neurology stream, Room no - Faculty room, second floor, Sector C, Vasant Kunj , New Delhi 110070 South West DELHI 110049 India |
| Phone |
9650086472 |
| Fax |
|
| Email |
garimawdhw@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pooja Anand |
| Designation |
Dean and Professor, Faculty of Physiotherapy SGT University |
| Affiliation |
SGT University |
| Address |
Faculty of Physiotherapy Department, Block D Basement, SGT University, Gurgaon- Badli Road, Budhera, Gurugram, Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9810240409 |
| Fax |
|
| Email |
pooja.physiotherapy@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Priyanka Rishi |
| Designation |
Associate Professor, Faculty of Physiotherapy, SGT University |
| Affiliation |
SGT University |
| Address |
Faculty of Physiotherapy Department, Block D Basement, SGT University, Gurgaon- Badli Road, Budhera, Gurugram, Haryana
Gurgaon HARYANA 122505 India |
| Phone |
8588878467 |
| Fax |
|
| Email |
priyanka.physio@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries center, PMR department , Ground floor , Sector C, IAA colony, Vasant Kunj, 110070 |
|
|
Primary Sponsor
|
| Name |
None |
| 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 |
| Garima Wadhwa |
Indian spinal injuries center |
Ground floor, pmr dpartment Indian spinal injuries center , sector C, Vasant Kunj, New Dehi South West DELHI |
9650086472
garimawdhw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G959||Disease of spinal cord, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham transcranial direct current stimulation with virtual reality assisted treadmill training |
Sham simulation for 30 seconds will be applied and then it will turned off. VR assisted treadmill protocol will be same for both groups. the intervention will be of 20 minutes , 15 sessions o be given in span of 4 weeks |
| Intervention |
Transcranial Direct Current Stimulation with virtual reality treadmill training |
It is a non invasive brain
stimulation technique in which involves low intensity direct currents to be applied via electrodes over head in order to stimulate brain regions and VR Assisted treadmill training involves participants to walk on treadmill along with viewing virtual environment on screen infront of treadmill.
The intervention will be given for 20 minutes, 15 sessions in total to be completed within 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Traumatic and non- traumatic spinal cord injury.
2. Age 18 years to 65 years.
3. ASIA grade C and D.
4. Level of lesion T1 to L2
5. Functional ambulatory category more than or equal to 2.
6. Who are able advance their leg on treadmill with 0.2 km/hour speed.
7. Atlest 3 months time since injury |
|
| ExclusionCriteria |
| Details |
1. Any other pre-existing neurological problem, musculoskeletal condition, cardiovascular or psychiatric problem which may interfere with the treatment.
2.Spasticity of grade 3 or more in lower extremities on Modified Ashworth Scale which may interfere with the treatment.
3.Visual or auditory impairment such that it impacts on the ability to participate.
4.Body Weight more than 150 kg.
5. Skin lesions or rash at potential sites which may interfere with the treatment or placing of electrodes of transcranial direct current stimulation or Grade 2 or higher-pressure ulcers (according to the National Pressure Ulcer Advisory Panel classification) that interfered with harness support or walking or standing.
6. History of seizure, migraine, headache or epilepsy, brain surgery.
7. History of recent episode of orthostatic hypotension or autonomic dysreflexia.
8.Cardiac pace-maker
9.Pregnancy
10.Intracranial or skull implants.
11.Previous experience of transcranial direct current stimulation or VR assisted treadmill training post SCI.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strength: Lower extremity moto score (ASIA)
Balance: Functional reach test, Berg balance scale
Gait : WICII, Kinetic and kinemti parameters through walker view, 10m walk test
|
At baseline and after 15 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional score: SCIM III
Quality of life: WHO-QOL BREF |
At baseline and after 15 sessions |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
12/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response (Others) - in case required by publication journal for supplementary attachment
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ the editor of publishing journal ].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background- Individuals with SCI possess significant challenges in motor function recovery. With those who able to achieve functional ambulation, they have impaired waking pattern, they tend to develop slow, inefficient unbalanced gait pattern with long cycle time and small strides. VR assisted treadmill training allows individual to correct their walking pattern through visual feedback. The training has been found effective in neurological population like stroke, multiple sclerosis, Parkinson’s disease etc. The growing body of research is emphasizing on the role of neuro-modulation including transcranial direct current simulation alone or in adjunct with other therapies. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation technique that has shown promise in various neurological conditions, including spinal cord injury (SCI). The application of tDCS involves delivering a low electrical current to specific areas of the brain through electrodes placed on the head. Recent evidence has explored the beneficial effects of transcranial stimulation on upper extremity functions and neuropathic pain among individuals with spinal cord injury. The application of transcranial direct current stimulation among spinal cord injury has shown mixed results for recovery of lower motor functions and ambulation. The available studies varies in session and location of the electrode placement. Moreover, there is dearth in literature that have combined innovative techniques.
Intervention: the 52 participants will be randomly assigned to intervention and sham group after baseline measurement . 20 minutes session for 15 times will be given and after 15 sessions post intervention measurements will be recorded. |