| CTRI Number |
CTRI/2024/02/063187 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| 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
|
TO improving walking and Balance after stroke using Brain Electrical Stimulation and exercises. |
|
Scientific Title of Study
|
Effect of Transcranial Direct Current stimulation along with proprioceptive neuromuscular of neuromuscular facilitation on Balance and Gait among stroke individuals. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHAYSTA KHAN |
| Designation |
PG student |
| Affiliation |
amity institute of health allied sciences |
| Address |
Lower ground floor F1 block room no LG06 Amity Institute of health allied Sciences. Amity university Noida sec 125 Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
06396403428 |
| Fax |
|
| Email |
khanshaysta2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
associate professor |
| Affiliation |
amity institute of health allied sciences |
| Address |
Lower ground floor room no 05 F1 block Amity Institute of health allied Sciences. Amity university Noida sec 125 Uttar Pradesh 201312
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHAYSTA KHAN |
| Designation |
PG student |
| Affiliation |
amity institute of health allied sciences |
| Address |
Lower ground floor F1 block room no LG06 Amity Institute of health allied Sciences. Amity university Noida sec 125 Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
06396403428 |
| Fax |
|
| Email |
khanshaysta2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Head Injury Foundation. Ground Floor. neuro rehab department room no.01.063 Lajpat Nagar 2,New Delhi Delhi 110024 |
|
|
Primary Sponsor
|
| Name |
Shaysta khan |
| Address |
Amity Institute of health Allied sciences Amity University students Noida UP Noida |
| Type of Sponsor |
Other [] |
|
|
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 Prateek Sharma |
Indian head injury foundation. |
Neuro rehab department ground floor 063,Lajpatnagar2 new Delhi 110024
New Delhi
DELHI |
9818146089
Prateek_physio@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee amity institute of health allied sciences AMITY UNIVERSITY UTTAR PRADESH |
Approved |
| no |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G460||Middle cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electrical Transcranial Direct current stimulation along with proprioceptive neuromuscular facilitation on Balance & Gait among Stroke individuals |
The combination of electrical Transcranial Direct current stimulation (tDCS) and proprioceptive neuromuscular facilitation (PNF) in stroke individuals aims to enhance motor recovery. tDCS may boost cortical excitability, while PNF focuses on improving neuromuscular control. Together, they have shown positive effects on balance and gait, crucial for functional independence in stroke survivors. Individual responses may vary, and ongoing research continues to refine the optimal parameters for these interventions. For the latest information, consult recent research or healthcare professionals familiar with neurorehabilitation advancements. Intervention duration is 4 weeks |
| Comparator Agent |
Treadmill Training ,proprioception neuromuscular facilitation techniques |
these techniques can improve Balance and Gait duration is 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient suffering from ischemic stroke.
Tinetti balance and gait scale scoring moderate patient able to walk
both gender
age 30-60 years |
|
| ExclusionCriteria |
| Details |
History of any Other neurological
condition. TBI, cranial nerve
dysfunction, Parkinson disease, ataxia
Any other problem like mental retardation.
Visual and hearing impairment.
No other neurological history of present
which affect balance and gait.
Diabetes neuropathy
Any orthopedics surgery which effect
balance, gait
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance Gait, walking speed |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| step length ,stride length, walking speed and balance dynamic |
baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
06/03/2024 |
| 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="4"
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
|
• Methodology: Thirty-six male and female stroke victims with hemiplegia, ranging in age from thirty to sixty, were included in this study at the Head Injury Foundation in Lajpat Nagar. Once the subject met all inclusion and exclusion requirements, a written consent document was provided. The patient was given chits with the numbers A and B to place them in the appropriate group after giving their assent. There were 15 participants in each group: 18 in the experimental group and 18 in the control group. Group A for Intervention
• Direct current stimulation, or tDCS. cathode electrode applied for 30 minutes per day, five days or weeks, to the mastoid process on the afflicted side of the brain. A mastoid process apposite electrode is positioned. • 20 repetitions of a rhythmic stabilizing exercise.two sets. • Tenth dynamic reversal
|