| CTRI Number |
CTRI/2012/02/002412 [Registered on: 09/02/2012] Trial Registered Prospectively |
| Last Modified On: |
21/06/2016 |
| 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
|
| Trial Acronym |
|
|
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
|
|
|
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"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |