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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response (Others) -  in case required by publication journal for supplementary attachment

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ the editor of publishing journal ].

  6. 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.

  7. 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.

 
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