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CTRI Number  CTRI/2012/02/002412 [Registered on: 09/02/2012] Trial Registered Prospectively
Last Modified On: 25/02/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of EMG and footswtch triggered stimulation in stroke patients with foot drop. 
Scientific Title of Study   A Comparative, Randomized, Double-blind Pilot Study to Evaluate Re-learning of Ankle function after an intensive 2-week Gait Re-training with Electromyogram (EMG)-triggered or Footswitch (SW)-trigger Functional Electrical Stimulation (FES) in Chronic Stroke patients with foot drop  
Secondary IDs if Any  
Secondary ID  Identifier 
EMG001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ALAKANANDA BANERJEE 
Designation  Head-Physiotherapy and Rehabilitation 
Affiliation  Max Superspeciality Hospital 
Address  Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
South
DELHI
110017
India 
Phone  9811020093  
Fax    
Email  alokabanerjee26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ALAKANANDA BANERJEE 
Designation  Head-Physiotherapy and Rehabilitation 
Affiliation  Max Superspeciality Hospital 
Address  Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
South
DELHI
110017
India 
Phone  9811020093  
Fax    
Email  alokabanerjee26@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ALAKANANDA BANERJEE 
Designation  Head-Physiotherapy and Rehabilitation 
Affiliation  Max Superspeciality Hospital 
Address  Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
Max Super Speciality Hospital,1, Press Enclave Road,Saket,New Delhi
South
DELHI
110017
India 
Phone  9811020093  
Fax    
Email  alokabanerjee26@gmail.com  
 
Source of Monetary or Material Support  
Monetary support-Department of Physiotherapy and Rehabilitation,Max Super Speciality Hospital, New Delhi  
 
Primary Sponsor  
Name  Department of Physiotherapy and RehabilitationMSSHwest 
Address  Max Super Speciality Hospital ,1 Press Enclave Road,Saket,New Delhi,India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Department of Clinical Neurophysiology georg August University  Dept of Clinical Neurophysiology, Georg-August-University, Robert Koch Strasse 40, Goettingen, germany 37075  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alakananda Banerjee  Max Super Speciality Hospital,  Dept of Physiotherapy and rehabilitation, 1, Press Enclave Road,Saket
South
DELHI 
9811020093

alokabanerjee26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Stroke Patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EMG Triggered FES   Frequency and intensity- as per comfortability of subjects Duration- 30 minutes/day for 6 alternate days means 1800 minutes/arm 
Comparator Agent  Footswitch Triggered FES   Frequency and intensity- as per comfortability of subjects Duration- 30 minutes/day for 6 aternate days means 1800 minutes/arm 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  •>6 months from a first clinical non-hemorrhagic or hemorrhagic stroke
•Medically stable
•Unilateral lower extremity hemi paresis
•Ankle dorsiflexor strength of ≤4/5 on the MRC scale, while seated
•Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an AFO.
•AFO is clinically indicated (foot drop during ambulation or inefficient gait patterns)
•NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
•Full voluntary dorsiflexion of the contralateral ankle
•Skin intact on hemiparetic lower extremity
•Able to don the FES system.
•Able to follow 3-stage commands
•Able to recall 2 or3 items after 30 minute
.Should volunteer and consent to participate in the study
 
 
ExclusionCriteria 
Details  •Brainstem stroke
•Epilepsy
•Severely impaired cognition and communication
•History of peroneal nerve injury
•History of Parkinsons, SCI, TBI, or multiple sclerosis, Uncontrolled seizure disorder
•Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
•Edema of the affected lower extremity
•Absent sensation of lower leg and foot
•Evidence of deep venous thrombosis or thromboembolism
•History of cardiac arrhythmias with hemodynamic instability
•Cardiac pacemaker or other implanted electronic system
•Botulinum toxin injections to any lower extremity muscle in the last 3 months
•Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in normality of linear envelopes of EMG of tibialis anterior muscle of affected limb.  2 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Usability rating scale  2 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2012 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Brief Summary  

This study is a randomized, double blind, pilot study to evaluate the re-learning of ankle function after an intensive 2-week gait re-training with electromyogram (EMG)-triggered or footswitch (SW)-triggered neuromuscular electrical stimulation (FES) in chronic stroke patients suffering from foot drop. In this subjects refereed to the department of physiotherapy and rehabilitation will be randomly allocated to either EMG-triggered or Footswitch-triggered FES group. Both the groups will use customized Walking man II drop stimulator with gait training on Treadmill for 6 minutes for 5 times, thrice a week for two weeks with sufficient rest in between the trials.

The motion analysis or camera/video will be conducted only during baseline, and post-intervention visits when the subject will walk voluntarily (without NMES) The user feedback based on Usability Rating Scale for their respective intervention (subject blind to the intervention) will be taken from the subject. A multivariate analysis of variance will be done to see any statistically significant differences between two groups (EMG- triggered FES vs. Footswitch-triggered

 
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