| CTRI Number |
CTRI/2021/06/034125 [Registered on: 09/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF BALANCE BOARD TRAINING WITH MIRROR RESPONSE AND COMPUTER BASED BALANCE BOARD TRAINING ON STABLE AND ACTIVE BALANCE AND QUALITY OF LIFE IN ELDERLY POPULATION |
|
Scientific Title of Study
|
EFFECT OF WOBBLE BOARD TRAINING WITH MIRROR FEEDBACK AND COMPUTER BASED BALANCE BOARD TRAINING ON STATIC AND DYNAMIC BALANCE AND QUALITY OF LIFE IN ELDERLY POPULATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini Fating |
| Designation |
Senior resident |
| Affiliation |
Ravi Nair collage of physiotherapy,sawangi |
| Address |
Opd no. 4, Department of community health physiotherapy, Ravi Nair physiotherapy College,sawangi(meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
08698571515 |
| Fax |
|
| Email |
tejaswinifating1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Bele |
| Designation |
Associate Professor, Department of Community Health Physiotherapy |
| Affiliation |
Ravi Nair collage of physiotherapy,(DMIMSU)Sawangi meghe, Wardha |
| Address |
OPD no. 4, Deapartment of Community health physiotherapy, Ravi Nair physiotherapy College
Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
08698571515 |
| Fax |
|
| Email |
drashishbele@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Bele |
| Designation |
Associate Professor, Department of Community Health Physiotherapy |
| Affiliation |
Ravi Nair collage of physiotherapy,(DMIMSU)Sawangi meghe, Wardha |
| Address |
OPD no. 4, Department of Community Health Physiotherapy,Ravi Nair physiotherapy College,sa
Near AVBRH hospital ,Wardha.
Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
08698571515 |
| Fax |
|
| Email |
drashishbele@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Medical Sciences |
| Address |
Sawangi meghe, Wardha |
| 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 |
| Tejaswini Fating |
Ravi Nair Physiotherapy College |
OPD no. 4, Deapartment of Community Health Physiotherapy, Ravi Nair Physiotherapy college, Sawangi (Meghe)
Wardha
MAHARASHTRA |
8698571515
tejaswinifating1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIMS (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy old patient related with balance issue |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
balance board with mirror feedback |
Balancing on balance board for 30 sec with 3 repetitions,Lateral tilt exercises for 30 sec with 3 repetitions, Anterior Posterior tilt exercises for 30 sec with 3 repetitions,Reach outs 30 repetitions,Forward and backward step balancing, Closed feet standing with eyes open and eyes closed for 30 sec each,Single leg stance on stable surface bilaterally for 30 sec each,Tandem walk position for 30 sec with 3 repetitions. |
| Intervention |
Computer based balnce board |
Balancing on balance board for 30 sec with 3 repetitions, Lateral tilt exercises for 30 sec with 3 repetitions, Anterior Posterior tilt exercises for 30 sec with 3 repetitions, Reach outs 30 repetitions, Forward and backward step balancing
6) Closed feet standing with eyes open and eyes closed for 30 sec each.
7) Single leg stance on stable surface bilaterally for 30 sec each.
8) Tandem walk position for 30 sec with 3 repetitions.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age group: above 60 years healthy individual able to understand and follow the simple information.
Can mobile and execute their functions of daily livings
male and female
|
|
| ExclusionCriteria |
| Details |
1) Significant cognitive disability that impeded their comprehension of instructions.
2) Musculoskeletal condition (fracture of lower limb, amputation), neurological (Parkinson disease, severe stoke, multiple sclerosis, vertigo) or visual, auditory impairments and severe conditions that might be affect the measurements.
3) Head injuries with or without loss of consciousness.
4) Use of foot orthotics or walking aids.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Tinetti performance oriented mobility Assessment (POMA) |
Base line and 4th week after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2)RAND SF-36 Quality of life questionnaire |
Base line and 4th week after treatment |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 1 |
|
Date of First Enrollment (India)
|
11/06/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fall is mostly caused due to lack of balance and also affect the quality of life, so the various Physiotherapy approaches are available for prevention and treatment of fall but very few studies utilized computerized balance board training program to improve the balance, hence need for the study is to find out the efficacy of balance board training & to enhancing balance and gait as well as the significance of these training on static and dynamic stability and quality of life in the geriatric population. Total 96 elderly people will be targeted who are about 60 years of age or older. Participants will be randomly separated into two groups (control or experimental group). The training session design for 4 weeks and each session 20-30 minutes. Outcome measures will be used to assess the static and dynamic stability and quality of life in the elder population group at pre and post of intervention. Data will be calculated and statistically calculated and results will be discussed. This clinical work seeks to equate the impact of traditional wobble board balance instruction in the elderly community and computer-based balance board preparation. To conclude, this work will help elderly people strengthen their static and dynamic equilibrium, and also increase their quality of life. |