| CTRI Number |
CTRI/2024/03/064808 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Control Trail to Study the Effects of Variable Frequency of Focal Muscle Vibration on Improving Tone Balance and Gait Kinematics in Stroke Individuals |
|
Scientific Title of Study
|
Effects of Variable Frequency of Focal Muscle Vibration on Improving Tone Balance and Gait Kinematics in Stroke Individuals A Randomized control trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Rai |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Neurophysiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9340657244 |
| Fax |
|
| Email |
rairekha241@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Irshad Qureshi |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Sawangi(Meghe), Wardha |
| Address |
Department of Neurophysiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Irshad Qureshi |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Sawangi(Meghe), Wardha |
| Address |
Department of Neurophysiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffamail.com |
|
|
Source of Monetary or Material Support
|
| Ravi nair physiotherapy college, Aachrya Vinobha Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research [deemed to be universitu], Sawangi (Meghe), Wardha, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Neurophysiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Anjali Rai |
Acharya Vinoba Bhave Rural OPD Neuro ICU Neuro Wards and Neurophysiotherapy Department |
Department of Neurophysiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi Wardha
Wardha
MAHARASHTRA |
9340657244
rairekha241@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Neurophysiotherapy |
The intervention was given for 5 days in a week till 6 weeks In this group, conventional neurophysiotherapy will also br given which will comprise of passive ROM, Neurodevelopmental treatment and proprioceptive neuromuscular facilitation technique, joint approximation were performed, positioning, bed mobility exercises and gait training |
| Comparator Agent |
Conventional neurophysiotherapy with Variable Focal Muscle Vibration |
The intervention was given for 5 days in a week till 6 weeks. Vibration given for different frequencies for 5 minutes with 1 minute of break to prevent muscle fatigue. it will be given to the affected area as concentric and eccentric controlled lengthening and shortening on the muscle belly. along with the above mentioned treatment, Conventional neurophysiotherapy will also be given passive ROM, Neurodevelopmental treatment and proprioceptive neuromuscular facilitation technique, joint approximation were performed, positioning, bed mobility exercises and gait training |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Both Males And Females Between 25 To 55years.
2.Patients Affected With Brunstorm Stage1,2,3&4
3.Confirmed Diagnosis With Single Lesion Detected By Brain (CT Or MRI).
4.Patients Affected By Acute, Subacute And Chronic Stroke.
5.Patients With Ischemic Or Hemorrhagic Stroke.
6.Patients Who Are Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with Traumatic Brain Injury (TBI) Spinal Cord Injury (SCI) Cancer Patients
2.Patients with Recent Lower Limb Fractures, Serious Orthopaedic Conditions.
3.Patients with DVT
4.Patients with Intracranial Metallic Implants And Pacemakers.
5.Patients Taken Botulin Toxin Treatment In The Previous 12 Months
6.Patients with Epilepsy
7.Enrolment in another clinical trial involving physiotherapy.
|
|
|
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 |
1.Tone grading scale (TGS)
2.Berg balance scale
3.Manual muscle testing (MMT)
4.Barthel index (BI)
5.Modified ashworth scale (MAS)
6.Voluntary control grading scale (VCG)
7.XSENS gait motion analysis
|
Outcome will be taken at baseline and 6 weeks and follow up will be taken at every 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Numerical pain rating scale
2. WHO quality of life |
Outcome will be taken at baseline and 6 weeks and follow up will be taken at every 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
12/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The
aim of the study is to evaluate the effect variable frequency of focal muscle
vibration as an rehabilitation approach in adjunct to conventional therapy on
flaccidity, spasticity, gait , balance, quality of life in patients with stroke
|