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CTRI Number  CTRI/2019/09/021270 [Registered on: 17/09/2019] Trial Registered Prospectively
Last Modified On: 14/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Electrical brain stimulation along with physical therapy effect on improving function in patients with sub-acute stroke  
Scientific Title of Study   Transcranial direct current stimulation combined with trunk targeted proprioceptive neuromuscular facilitation and its effects on impairments, activity limitations and participation restrictions of subjects with sub-acute stroke: A randomized controlled trial  
Trial Acronym  TDCS & PNF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Kumar Midde 
Designation  Head of The Department 
Affiliation  KIMS 
Address  Department of Physiotherapy, Krishna Institute of medical Sciences, Ministers road, Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  00919908167776  
Fax    
Email  ajaymidde85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajay Kumar Midde 
Designation  Head of The Department 
Affiliation  KIMS 
Address  Krishna Institute of medical Sciences, Ministers road, Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  00919908167776  
Fax    
Email  ajaymidde85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ajay Kumar Midde 
Designation  Assistant Professor 
Affiliation  KIMS 
Address  Krishna Institute of medical Sciences, Ministers road, Secunderabad

Hyderabad
TELANGANA
500003
India 
Phone  00919908167776  
Fax    
Email  ajaymidde85@gmail.com  
 
Source of Monetary or Material Support  
Department of Medical rehabilitation Sciences, College of Applied Medical Science, C/3/108, Guraiger, King Khalid University, Abha, 61421, Kingdom of Saudi Arabia  
 
Primary Sponsor  
Name  King Khalid University 
Address  C/3/108, Building C, Guraiger, King Khalid University, Abha, Kingdom of Saudi Arabia 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Saudi Arabia
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaya Shanker Tedla  Krishna Institute of Medical Sciences  Department of Physiotherapy, 2nd floor, New Building, Ministers Road, Secunderabad
Hyderabad
TELANGANA 		 7674897379

jtedla@kku.edu.sa 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Scientific Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physical Therapy  In this group, the total intervention will be for one and a half hour. Muscle elongation exercises for tight muscles, strengthening exercises for weak muscles, weight-bearing and shifting in sitting and standing, range of motion exercises and gait training activities.  
Intervention  Conventional Physical Therapy, Trunk targeted proprioceptive neuromuscular facilitation (PNF)  In this group, the total intervention will be for one and half hour. It includes one hour of Conventional Physical Therapy and 30 minutes trunk targeted PNF. The PNF exercises were based on functional limitation and capability of an individual patient. The therapist will strictly follow the fundamental principles of the PNF method like manual contact, body position and body mechanics, verbal commands, vision, traction/approximation, stretch, timing, and repetitions. Trunk chopping and lifting patterns, bilateral lower limb/upper limb patterns, combined scapular, and pelvic patterns will be used to facilitate trunk. These exercises will be done in different positions like supine, side-lying, prone, sitting and standing based on patient capabilities. Techniques of PNF are incorporated based on patient requirement but Stabilizing reversals / Rhythmic stabilization are mandatory techniques. 
Intervention  Trans Cranial Direct Current Conventional Physical therapy , Stimulation with Trunk targeted and Proprioceptive Neuro muscular facilitation  In this group, the total intervention will be for one and a half hour. It includes 40 minutes of Conventional Physical Therapy, 30 minutes trunk targeted PNF and 20 minutes tDCS. Details of tDCS are provided below. tDCS treatment parameters Machine used Neuro-Conn DC stimulator plus or Sotirex tDCS machine Montage basis International EEG 10 – 20 system Software used to test montage Bonsai—Model Solution Analyzer Montage used Bicephalic Montage Anode on affected side C3-C4 Cathode on unaffected side C3-C4 Pad size 5X5 cm The intensity of the current 2 mA Duration of treatment 20 min Number of sessions per week 4 Total number of treatment weeks 6 Total number of session 24 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age range 18-75 years
2. First-time supratentorial stroke diagnosed by MRI/CT scan
3. Between 7 days to 6 months post-stroke
4. Able to understand and follow the commands 
 
ExclusionCriteria 
Details  1. Any metals in the cranium/ cochlear implants/ cardiac pacemakers
2. Having an unstable epileptic disorder
3. Associated comorbid diseases like cancer/ HIV/Hepatitis or any other neuromuscular disorders which affect the subjects capability to do exercise 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Trunk impairment scale measures trunk activity and measured as a clinical test 2. Fugl-Meyer Assessment of Motor Recovery after stroke (FMA) measures upper and lower limb activity and measured as a clinical test 3. 10 Meter Walk Test (10mWT) measures gait speed and measured as a clinical test 4. Timed up and go test measures balance and gait activity
5. Wolf Motor Function Test measures upper limb activity and measured as a clinical test
6. Stroke Specific Quality of life  		 Baseline and after 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Age 2. Gender 3. Stroke Onset 4. Type of Stroke 5. Severity of Stroke 6. Type of Treatme  These secondary outcomes required only for doing correlations they are obtained on week one. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="27" 
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 1/ Phase 2 
Date of First Enrollment (India)   17/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/09/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Background and study aim: Stroke is the foremost cause of death and disability throughout the world. Combining the neuromodulation capability of Transcranial Direct Current Stimulation (tDCS) with a strong clinical treatment tool like Proprioceptive Neuromuscular Facilitation (PNF) could make excellent improvements in the lives of stroke population. tDCS is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. A constant, low-intensity current is passed through two electrodes placed over the head which modulates brain cell activity. PNF stretching is an advanced form of flexibility training. It involves the contraction and stretching of muscles. Currently, there is dearth of literature pertaining to this combination of tDCS with PNF in improving function and quality of life in subjects with subacute stroke. 
The aim of this study is to find the effect of  tDCS combined with trunk targeted PNF on impairments, activity limitations and participation restrictions of subjects with sub-acute stroke
Who can participate? Stroke patients aged between 18-75 years who meet the inclusion criteria
What does the study involve? The participants undergo some evaluations, tDCS, and physical exercise treatments over a six week period.
What are the possible benefits and risks of participating? There is a possibility that the patient functional capacity will improve and there is no critical risk of participating in the study Some subjects can feel some fatigue after the exercise
Where is the study run from? King Khalid University, Saudi Arabia
When is the study starting and how long is it expected to run for? May 2019 to May 2020
Who is funding the study? Investigator-initiated and funded
Who is the main contact? Dr. Jaya Shanker Tedla jtedla@kku.edu.sa 
 
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