| CTRI Number |
CTRI/2024/09/074144 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Two different therapies for hand function improvement in stroke |
|
Scientific Title of Study
|
Combined effect of Transcranial direct current stimulation (tDCS) and Task Specific Training in Upper Limb Motor Functions in Stroke: A Randomized controlled 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 |
Saurabh Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room No. 39, Sagar Floor, KLES
Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9819536897 |
| Fax |
|
| Email |
psaurabh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room No. 39, Sagar Floor, KLES
Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9886288225 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room No. 39, Sagar Floor, KLES
Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9819536897 |
| Fax |
|
| Email |
psaurabh1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and Medical research centre, Nehru Nagar, Belgaum, Karnataka.
590010 |
|
|
Primary Sponsor
|
| Name |
Saurabh Patil |
| Address |
Advanced Physiotherapy Centre, Room No. 39, Sagar Floor, KLES
Dr. Prabhakar Kore Hospital and MRC., Belgavi- 590010, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Saurabh Patil |
KLEs Dr. Prabhakar Kore Hospital and Medical research centre |
Sagar Floor Advanced Physiotherapy, Room no- 39 Belgaum, Karnataka.
590010
Belgaum
KARNATAKA |
9819536897
psaurabh1999@gmail.com |
|
|
Details of Ethics Committee
|
| 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 |
| Comparator Agent |
Task specific training |
Task-specific training will center on the regular and repetitive practice of meaningful
tasks that can be completed within the range of voluntary motion. These tasks will be
gradually integrated and tailored based on the patients progress. Every task will be able
to be repeated and have a useful purpose. it will be given for 30 minutes for 5
days/week for 2 weeks. followed by 30 minutes of conventional treatment.
The conventional treatment will include Neurofacilitation/inhibition exercises,
strengthening exercises and Range of motion exercises for 30 minutes in both groups. |
| Intervention |
tDCS+ Task specific training |
tDCS (1mA) will be delivered for 30 min through electrodes soaked with sodium-chloride
solution.The anode will be placed over the ipsilesional area and cathode will be placed
over the contralesional motor cortex (C3-C4) of international 10-20 EEG electrode
system. tDCS will be applied for 30 min and simultaneously Task specific training will
be continued followed by 30 minutes of conventional treatment for 5days/week for 2
weeks |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age group of 21-70 years of all genders willing to
participate
History of first stroke more than one month.
MMSE score 25 or more.
Spasticity according to MAS ranging from grade 1 to grade 2. |
|
| ExclusionCriteria |
| Details |
Participants with Aphasia, epilepsy, upper limb joint contracture, perceptual
deficits such hemineglect and Apraxia along with Psychiatric illness.
Other conditions like Intracranial metallic implants, Surgeries over the
cranium |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugyl Meyer Assessment – Upper Extremity,
Wolf Motor Function Test (WMFT)
Modified Ashworth Scale |
Baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2024 |
| Date of Study Completion (India) |
01/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
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
|
Participants will be selected according to the inclusion and exclusion criteria, and then will be randomly allocated into 2 groups of intervention. Group A will receive tDCS and Task Specific training for upper limb combined along with conventional therapy. Group B will receive Task specific training for upper limb along with conventional therapy. Baseline data will be taken using Fugyl Meyer Motor Assessment – Upper Extremity (A-D components) ,Wolf Motor Function Test & Modified Ashworth scale. |