| CTRI Number |
CTRI/2024/08/071976 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Backward Chaining Technique to reduce fear of falls , improve balance in BPPV patients. |
|
Scientific Title of Study
|
Backward Chaining Technique to reduce fear of fall, improve balance and quality of life in BPPV patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zareen Fatima |
| Designation |
Post Graduate |
| Affiliation |
Durgabai Deshmukh Hospital and Research Centre |
| Address |
Durgabai Deshmukh College of Physiotherapy , Adikmet, Vidyanagar, Hyderabad, Telangana 500044, India.
Hyderabad
TELANGANA
500044
India |
| Phone |
7671999747 |
| Fax |
|
| Email |
qadeerzareen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Durga Reddy |
| Designation |
Professor |
| Affiliation |
Durgabai Deshmukh Hospital and Research Centre |
| Address |
Durgabai Deshmukh College of Physiotherapy ,Adikmet, Vidyanagar, Hyderabad , Telangana 500044, India.
Hyderabad
TELANGANA
500044
India |
| Phone |
9492925784 |
| Fax |
|
| Email |
abbadidurga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Durga Reddy |
| Designation |
Professor |
| Affiliation |
Durgabai Deshmukh Hospital and Research Centre |
| Address |
Durgabai Deshmukh College of Physiotherapy , Adikmet , Vidyanagar, Hyderabad, Telangana 500044 , India.
Hyderabad
TELANGANA
500044
India |
| Phone |
9492925784 |
| Fax |
|
| Email |
abbadidurga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Durgabai Deshmukh Hospital and Research Centre, Adikmet, Vidyanagar, Hyderabad, Telangana 500044, India. |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Durgabai Deshmukh Hospital and Research Centre ,Adikmet, Vidyanagar, Hyderabad, Telangana 500044 , India. |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| A Durga Reddy |
Durgabai Deshmukh Hospital and Research Centre |
Durgabai Deshmukh College of Physiotherapy / Department of Physiotherapy/ Room number 01
Hyderabad
TELANGANA |
9492925784
abbadidurga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE OF DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H811||Benign paroxysmal vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Backward Chaining Technique |
The patient will be practicing moving down the sequence as far as they are able and then getting back up again. When the patient is able to achieve a move easily, he/she will be encouraged to progress to the next stage. The patient will also receive demonstrations of the correct moves and practices and some more specific moves (rolling and moving from side lying to side sitting). The patients will receive 30 minutes of Conventional Vestibular rehabilitation exercises with 20 minutes of Backward Chaining Technique for 5 days per week for a total of 4 weeks. |
| Comparator Agent |
Conventional Vestibular Exercises |
The subjects in this group will receive conventional exercise program consisting of gaze stability exercises and Cawthorne Cooksey exercises. The patients will receive 30 minutes of Conventional Vestibular Exercises for 5 days per week for a total of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who have ENT/NEUROLOGIST clearance to undertake Vestibular exercises.
2 Patients who score below 45 out of 56 on the Berg Balance Scale.
3 Patients who score below 10 out of 12 on the 4 item Dynamic Gait Index
4 Patients who can effectively follow verbal instructions |
|
| ExclusionCriteria |
| Details |
1 Patients who are diagnosed with Vestibular Neuronitis.
2 Patients who are diagnosed with Labyrinthitis.
3 Patients who are diagnosed with Menieres Disease.
4 Patients who are diagnosed with Tinnitus.
5 Patients who are diagnosed with other associated neurological conditions.
6 Patients who are unwilling to participate in the study will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 BERG BALANCE SCALE
2 SHORT FALL EFFICACY SCALE - INTERNATIONAL |
BASELINE, 4TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 VESTIBULAR ACTIVITIES OF DAILY LIVING
2 4 ITEM DYNAMIC GAIT INDEX |
BASELINE, 4TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| 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
|
NUMEROUS STUDIES HAVE BEEN CONDUCTED ON THE EFFECTIVENESS OF DIFFERENT REHABILITATION STRATERGIES TO REDUCE FEAR OF FALL, IMPROVE BALANCE AND QUALITY OF LIFE IN BENING PAROXYSMAL POSITIONAL VERTIGO PATIENTS BUT NONE HAVE EXAMINED THE EFFECTIVENESS OF BACKWARD CHAINING TECHNIQUE. BACKWARD CHAINING TECHNIQUE IS ASSUMED TO BE BENEFICIAL FOR VESTIBULAR PATIENTS WHO EXPERIENCE FALLS AND FEAR OF FALLING DUE TO THEIR BALANCE AND COORDINATION ISSUES. EVIDENCE SUPPORTS BACKWARD CHAINING TECHNIQUE APPROACH HELPS THE PATIENT FEEL LESS ANXIOUS ABOUT FALLING AND GAIN BETTER BALANCE, BOTH OF WHICH CAN ENHANCE THEIR QUALITY OF LIFE OVERALL IN GERIATRIC POPULATION, STROKE POPULATION. THEREFORE THIS STUDY EXAMINES WHETHER AND TO WHICH EXTENT CAN BACKWARD CHAINING APPROACH HELP VESTIBULAR PATIENTS WITH THEIR FEAR OF FALLING, IMPROVING BALANCE AND QUALITY OF LIFE OVER CONVENTIONAL METHOD OF PHYSIOTHERAPY MANAGEMENT. |