| CTRI Number |
CTRI/2023/11/059438 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| 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
|
Effect of PNF Neck Patterns and Vestibular Rehabilitation for balance in stroke : RCT |
|
Scientific Title of Study
|
Effect Of PNF Neck Patterns And Vestibular Rehabilitation Exercises For Balance In Post Stroke Patients: A Randomized Controlled 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 |
Sandhya Rani Nurukurthi |
| Designation |
PG Student |
| Affiliation |
Srinivas University |
| Address |
Neuro OPD, Institute Of Physiotherapy, Srinivas University, Pandeshwar, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7893533293 |
| Fax |
|
| Email |
sandhyaraninurukurthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Premkumar |
| Designation |
Associate Professor |
| Affiliation |
Srinivas University |
| Address |
Neuro OPD, Institute Of Physiotherapy, Srinivas University, Pandeshwar, Mangalore,
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9442508754 |
| Fax |
|
| Email |
80pk2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Rani Nurukurthi |
| Designation |
PG Student |
| Affiliation |
Srinivas University |
| Address |
NEURO OPD, Institute Of Physiotherapy, Srinivas University, Pandeshwar, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7893533293 |
| Fax |
|
| Email |
sandhyaraninurukurthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro OPD, Institute Of Physiotherapy, Srinivas University, Pandeshwar, Mangalore |
|
|
Primary Sponsor
|
| Name |
Sandhya Rani Nurukurthi |
| Address |
Neuro OPD, Institute Of Physiotherapy, Pandeshwar, Mangalore |
| 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 |
| Sandhya Rani Nurukurthi |
Srinivas University |
Neuro OPD, Institute Of Physiotherapy, Srinivas University, Pandeshwar, Mangalore
Dakshina Kannada
KARNATAKA |
7893533293
sandhyaraninurukurthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY 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 |
| Intervention |
PNF Neck Patterns And Vestibular Rehabilitation Exercises |
PNF Neck Patterns And Vestibular Rehabilitation Exercises For 30 Minutes, 5 Times A Week For 6 Weeks |
| Comparator Agent |
Stretching Exercises, Functional Mat Activities And Walking Training Exercises |
Each For 10 Minutes, Total 30 Minutes A Day For 5 Times A Week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
subjects diagnosed with first ever stroke with period of less than 6 months and with neck flexor and extensor muscles assessed as greater than fair in strength. patients capable of walking independently for at least 1minute without any external support10
|
|
| ExclusionCriteria |
| Details |
subjects with vestibular and visual defects, chronic neck pain, severe disabling arthritis and any spinal surgeries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static Balance - Bertac Force Platform
Dynamic Balance-Dynamic Gait Index |
Baseline,3months and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality Of Life-Stroke Specific Quality Of Life Scale |
Baseline, 12 weeks & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/11/2023 |
| Date of Study Completion (India) |
31/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
EFFECT OF PNF NECK PATTERNS AND VESTIBULAR REHABILITATION EXERCISES FOR BALANCE IN POST STROKE PATIENTS:A RANDOMIZED CONTROL TRIAL GOT ETHICAL APPROVAL FROM SRINIVAS UNIVERSITY ETHICS COMMITTIEE TO PROCEED
IMPAIRED BALANCE IS THE MOST DISABLING FACTOR IN THE POST STROKE PATIENTS. SENSORY REWEIGHTING IS ALSO DISTURBED. BALANCE IS CONTRIBUTED BY VISUAL,VESTIBULAR AND SOMATOSENSORY INTEGRATION. VESTIBULAR REHABILITATION EXERCISES INCREASE THE CENTRAL ADAPTATION BY REPETITIVE EXERCISES AND PNF NECK PATTERNS IMPROVE THE HEAD AND NECK MOVEMENTS BY IMPROVING THE PROPRIOCEPTION OF NECK MUSCLES, WHICH ARE HELPFUL IN MAINTAINING THE BALANCE.
|