| CTRI Number |
CTRI/2024/06/068613 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| 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
|
Advanced Physiotherapy techniques to train balance in stroke individuals |
|
Scientific Title of Study
|
Effectiveness Of Vestibular Rehabilitation As An Adjunct To Pelvic Proprioceptive Neuromuscular Facilitation On Alignment Of Pelvis, Balance And Trunk Control In Chronic Stroke Individuals: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shetty Sakshi Shekhar |
| Designation |
Post-Graudate |
| Affiliation |
Nitte Institute of physiotherapy NITTE(Deemed to be university) |
| Address |
Department of physiotherapy,room no 20,second based division,Nitte Institute of physiotherapy NITTE(Deemed to be university)Derlakatte,Mangalore,Karnataka,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8369571030 |
| Fax |
|
| Email |
sakshishetty1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Assosiate Proffesor |
| Affiliation |
Nitte Institute of physiotherapy NITTE(Deemed to be university) |
| Address |
Department of physiotherapy,room no 20,second based division,Nitte Institute of physiotherapy NITTE(Deemed to be university)Derlakatte,Mangalore,Karnataka,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Krishna Kovela |
| Designation |
Assosiate Proffesor |
| Affiliation |
Nitte Institute of physiotherapy NITTE(Deemed to be university) |
| Address |
Department of physiotherapy,room no 20,second based division,Nitte Institute of physiotherapy NITTE(Deemed to be university)Derlakatte,Mangalore,Karnataka,India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte institute of physiotherapy(Nitte Deemed to be University) Derlakatte Mangalore-575018. |
|
|
Primary Sponsor
|
| Name |
Nitte Institue Of Physiotherapy |
| Address |
Department of Physiotherapy Room no 20 Second based division,Nitte institue of physiotherapy(Nitte Deemed to be university)Derlakatte Mangalore,Karnataka India |
| 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 Rakesh Krishna Kovela |
Justice KS Hegde Charitable Hospital |
Room No 20 Department Of Physiotherapy,Medical science complex Derlakatte Mangaluru Dakshina Kannada 575018
Dakshina Kannada
KARNATAKA |
7204346274
rakesh.krishna@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
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 |
Pelvic pnf and Conventional therapy |
Standard Care group will be receiving pelvic PNF along with the conventional physiotherapy for 1hour a day, 5 days a week for 4 weeks. |
| Intervention |
Vestibular Rehabilitation therapy and pelvic pnf |
Vestibular rehabilitation therapy and pelvic PNF along with conventional physiotherapy for 1 hour a day, 5 days a week for 4 weeks. Controlled Group will be receiving pelvic PNF and conventional physiotherapy for 45 minutes a day, 5 days a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with chronic stroke for the first time.
2.Patients Brunnstrom stage of recovery greater than or equal to 2 lower limbs between 40-60 years of age both males and females.
3.Patients capable of following commands (MMSE above 23) patients with pelvic asymmetry, balance and trunk control impairments
4.Patients who were able to walk with or without walking aids.
5.Patients with Ischemic stroke.
|
|
| ExclusionCriteria |
| Details |
1.Patients with any other diagnosis along with stroke.
2.Patients who undergone any spine and lower limb surgery in past one year span.
3.Patients with any fixed spinal deformity.
4.Patients who are under antiepileptic medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Palpation meter, Berg-balance scale,Trunk impairment scale |
1st pre-evaluation and last day of post-evaluation in 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini-Mental State Examination Scale |
Day1 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2024 |
| Date of Study Completion (India) |
07/02/2025 |
| 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)
|
Not Applicable |
| 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
|
The study states that exclusive pelvic pnf over alignment of pelvis is proven to be beneficial.Vestibular Rehabilitation is proved to improve balance by targetting gaze and postural stability but theres a dearth in literature which emphazies on impart of vestibular rehabilitation on alignment of pelvis,balance and trunk control which will be used along with pelvic pnf.Thus The study is warranted to be conducted to see the effect of vestibular rehabilitation so to see the impact and changes in the treatment for chronic stroke individuals.Theres evidences telling that vestibular rehabilitation is affective. |