| CTRI Number |
CTRI/2024/01/061375 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Transcranial Direct Current Stimulation and Bilateral Arm Training in Individuals with neurological upper limb motor impairments |
|
Scientific Title of Study
|
Effect of Bihemispheric Transcranial Direct Current Stimulation and Bilateral Arm Training in Neurological Upper Limb motor impairments: 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 |
Dr Raghavendrasingh Dharwadkar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Neurology department OPD no.39, Nehru Nagar,Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Neurology department OPD no.39, Nehru Nagar,Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Patil |
| Designation |
PG Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Neurology department OPD no.39, Nehru Nagar,Belgavi
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Neurology department OPD no.39, Nehru Nagar,Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9819536897 |
| Fax |
|
| Email |
psaurabh1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belgaum |
|
|
Primary Sponsor
|
| Name |
KAHER institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar,Belgavi- 590010, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Raghavendrasingh Dharwadkar |
KAHER Institute of Physiotherapy |
K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Neurology department OPD no.39, Nehru Nagar,Belgavi
Belgaum
KARNATAKA |
9886288225
raghavendrasingh@klekipt.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee of KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bihemispheric Transcranial Direct Current Stimulation |
This intervention will be given 5 times a week for 2 weeks. It is a non invasive procedure in which the electrodes will be placed on C3-C4 according to the International 10-20 EEG electrode system. Before placement the electrodes will be soaked with sodium chloride solution. The anode will be placed over the ipsilesional area and cathode will be placed over the contralesional area, a current of 1mA will be delivered for a duration of 20 minutes followed by 30 minutes of conventional treatment. |
| Comparator Agent |
Bilateral Arm Training |
This intervention will be given 5 times a week for 2 weeks. In this the exercises will almost include Activities of daily living such as holding a bottle with one hand and opening it with other hand and then pouring water from that bottle to a the glass and drinking it with the other hand, folding laundry, pushing a chair with both hands, placing two similar objects, organizing a drawer, wringing of clothes, tearing sheets of paper, folding and unfolding sheets of paper using both hands. All these activities will be done for a total time of 30 minutes. Followed by 20 minutes of conventional treatment.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants willing to participate
2.Participants of age group 21-75 years of all genders
3.Participants with history of traumatic brain injury
and cerebral vascular accident having upper limb
motor impairments.
4.Hemodynamically stable condition.
5.Unilateral motor impairment.
6.Should be able to follow the commands.
7.Spasticity in affected upper limb ranging from grade
1to grade 3 as per Modified Ashworth Scale
|
|
| ExclusionCriteria |
| Details |
1.Aphasia
2.Epilepsy
3.Intracranial metallic Implants or any
surgeries over cranium
4.Psychiatric illness
5.Peripheral nerve injuries
6.Musculoskeletal impairments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wolf Motor Function Test |
Day 1 and day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fugyl Meyer Assessment-Upper Extremity |
Day 1 and day 10 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/01/2024 |
| Date of Study Completion (India) |
01/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
20 participants with neurological upper limb motor impairments will be selected on the basis of inclusion and exclusion criteria and will be randomized into two groups by sealed envelope method for tDCS and Bilateral Arm Training. tDCS will be delivered for a duration of 20 minutes followed by 30 minutes of conventional treatment and in bilateral arm training activities which includes involvement of both arms will be given for 30 minutes followed by 20 minutes of conventional treatment. |