| CTRI Number |
CTRI/2019/08/020969 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of electrical stimulation in facial deviation after stroke |
|
Scientific Title of Study
|
Effect of transcutaneous electrical nerve stimulation on facial asymmetry in acute ischemic middle cerebral artery syndrome – a single blinded randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zalino Paphino |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Room no 1, Department of Physiotherapy, Ground floor, Nitte Institute of Physiotherapy, Nithyananda Nagar, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8001387797 |
| Fax |
|
| Email |
zalipaphino@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukumar S |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Room no 1, Department of Physiotherapy, Ground floor, Nitte Institute of Physiotherapy, Nithyananda Nagar, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9611839013 |
| Fax |
|
| Email |
suku729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zalino Paphino |
| Designation |
Post graduate student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Room no 1, Department of Physiotherapy, Ground floor, Nitte Institute of Physiotherapy, Nithyananda Nagar, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8001387797 |
| Fax |
|
| Email |
zalipaphino@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zalino Paphino Address: Nitte Institute of Physiotherapy, Office room, Ground floor, Nithyananda Nagar, Deralakatte, Mangalore- 575018 |
|
|
Primary Sponsor
|
| Name |
Zalino Paphino |
| Address |
Nitte Institute of Physiotherapy, Deralakatte, Mangalore, 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 |
| Zalino Paphino |
Justice KS Hegde Charitable Hospital |
Department of Physiotherapy, Basement 2, Room no. 20, NITTE University, Deralakatte, Mangalore.
Dakshina Kannada
KARNATAKA |
8001387797
zalipaphino@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Traditional Facial Exercises |
Facial exercises and massage techniques for decreasing the facial asymmetry for 10 minutes |
| Intervention |
Transcutaneous Electrical Nerve Stimulation |
An electrical instrument for stimulation of nerves |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with acute MCA stroke
Participants with the evidence of contra lateral lower quadrant facial palsy
Patients willing to participate
|
|
| ExclusionCriteria |
| Details |
Uncooperative patients
Participants with cognitive impairments
Participants with contraindications of TENS like
Altered sensation
Skin infections
Active tumors
- Over mucosal surfaces
- Over the eyes
- Person with Arterial or venous diseases
- Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| House Brackmann Scale |
First day and at the end of two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sunnybrook Facial Grading System |
First day and at the end of two weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2019 |
| Date of Study Completion (India) |
20/02/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to compare the effect of Transcutaneous Electrical Nerve Stimulation and facial exercises with the effect of exercises alone in post stroke facial asymmetry. According to literature search, there is a lack of literature of effectiveness of Transcutaneous Electrical Nerve Stimulation on the
facial weakness post stroke. Hence, this study has been taken up. Patients will be allocated into groups I and II. Patients in both groups will be taught facial exercises whereas patients in group I will be given additional Transcutaneous Electrical Nerve Stimulation. Outcome measures will be taken on the first day and at the end of two weeks. Participants will be treated once a day,six times a week.
|