| CTRI Number |
CTRI/2022/08/044551 [Registered on: 01/08/2022] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effectiveness of virtual reality-based rehabilitation on the fear of fall, balance, and mobility in Post-Menopausal Women. |
|
Scientific Title of Study
|
Efficacy of virtual reality-based rehabilitation on the fear of Fall, Balance, and Mobility in Post-Menopausal Women – A 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 |
Prasad Pramod Dhage |
| Designation |
MPT Student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887448632 |
| Fax |
|
| Email |
drprasaddhage24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Patil |
| Designation |
Professor and HOD |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709409637 |
| Fax |
|
| Email |
shubhangipatil148@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Patil |
| Designation |
Professor and HOD |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709409637 |
| Fax |
|
| Email |
shubhangipatil148@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital
|
| Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha |
| Ravi Nair Physiotherapy College |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha |
| Address |
Department Of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha, Maharashtra 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Prasad Pramod Dhage |
Acharya Vinoba Bhave Rural Hospital |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
7887448632
drprasaddhage24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, RNPC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group. |
Those Subjects in the control group should undergo conventional therapy for 60 mins a day, 3days a week for 6 weeks. The program consists of
1) Warmup exercises include spot marching, jogging, jumping for 10 minutes.
2) Sitting Activities includes-
a) Sitting in a regular, comfortable position.
b) Sitting, transferring weight in all directions.
c) Multidirectional functional reach when sitting.
d) Sitting and picking something up from the floor
3) Standing Activities includes-
a) Stand in a normal, relaxed position.
b) Stand with your feet together (narrow base of support).
c) One-foot standing
d) Standing in a straight line with one foot in front of the other (tandem position).
e) Standing: from open to closed eyes (Romberg test).
f) Stand with their eyes open and their eyes closed in a tandem position (Sharpen Romberg test).
g) Multidirectional functional reach when standing.
4) Walking Activities includes-
a) Walk with your feet on the floor markings.
b) Take a sideways walk
c) Walk in the reverse direction.
d) Walk in a cross-stepping manner.
e) Alternate directions while walking in a circle.
f) Walk: on your heels.
g) Walk on your toes.
h) spot marching.
i) Turn your head horizontally and vertically as you walk.
j) Move around or over barriers.
k) Climbing stairs with a railing.
l) Climbing stairs without a railing.
m) Stair climbing: one step at a time
n) Stair climbing: step – overstep.
Frequency – 3 days/week
Intensity – 30 minutes of moderate-intensity exercise (Fast walking).
or 20 minutes of high-intensity exercise (running)
5) Resistance and weight-bearing exercises.
Frequency – 2 to 3 days/week
Intensity – 8 to 12 rep that leads to muscle fatigue.
Includes – Strengthening exercises, resistance exercises, walking with weight (to increase body weight to get stimulus for increasing bone density)
|
| Intervention |
Virtual Reality- Based Rehabilitation. |
The experimental groups participants will be expected to complete the exercises throughout the 30-minute virtual reality intervention. (Richie’s plank experience game) playing various roles in a virtual environment. By merely turning the head, the patient will be able to look around using the oculus quest Head Mounted Device. It has a high level of immersion and is similar to a realistic simulation.
Richie’s Plank Experience – The game’s purpose is to create a virtual reality environment to focus the patient on the exercise protocol and aimed at helping patients with balance, mobility, and fear of falling. In this game, the patient is supposed to walk on the floor then gradually progress in walking with hurdles. Then in another mode patient need to go in a lift then walk on the plank in which he/she experienced fear of falling from the plank (Surface Area) and then later it progresses to falls from height. It is generally used to improve the balance of the patient. There is a progression level in this game that will be upgraded step by step.
|
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Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1) Menopausal women after 5 Years with Age between 55 - 80 years.
2) Patients with (low and moderate risk) balance affected.
3) MMSE (Mini-Mental Scale Examination) greater than equal to 24.
|
|
| ExclusionCriteria |
| Details |
1) Patients with severe risk of balance affected.
2) Recent Fracture or any surgery.
3) Any neurological condition like CVA, vestibular dysfunction.
4) Any cardiorespiratory condition such as uncontrolled hypertension and Diabetes mellitus that might affect the intervention.
5) Patients having visual defects.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go test (TUG). |
The outcomes will be assessed pre-intervention on 1st day and will be followed up within 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Falls Efficacy Scale – International. |
The outcomes will be assessed pre-intervention on 1st day and will be followed up within 6 weeks. |
| Functional Reach test. |
The outcomes will be assessed pre-intervention on 1st day and will be followed up within 6 weeks. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2022 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The present study intends to evaluate the effect of virtual reality-based rehabilitation on the fear of fall, balance, and mobility in postmenopausal women. A single-blinded study is presented.
|