| CTRI Number |
CTRI/2021/12/038962 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| 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
|
Cognitive training for balance in geriatric population. |
|
Scientific Title of Study
|
Comparison of Cognitive training versus Conventional training on balance in Geriatric population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hetal Shah |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Sunandan Divatia School of Science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Super Speciality Hospital, SV road, Vile Parle(W), Mumbai.
Mumbai (Suburban)
MAHARASHTRA
4000056
India |
| Phone |
|
| Fax |
|
| Email |
hetal61096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailja Mehta |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science, NMIMS University |
| Address |
Bhaidas Sabhagriha Building, Bhaktivedanta Swami Marg, Vile Parle (W), Mumbai.
Mumbai (Suburban)
MAHARASHTRA
4000056
India |
| Phone |
|
| Fax |
|
| Email |
shailja.mehta@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Hetal Shah |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Sunandan Divatia School of Science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Super Speciality Hospital, SV road, Vile Parle(W), Mumbai.
Mumbai (Suburban)
MAHARASHTRA
4000056
India |
| Phone |
|
| Fax |
|
| Email |
hetal61096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Sports Medicine, Nanavati Max Super Specialty Hospital |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ali irani |
Nanavati Super speciality Hospital |
Department of Physiotherapy, Ground floor, Nanavati Super Speciality Hospital, SV road, Vile Parle(W), Mumbai.
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive therapy |
Cognitive exercises targeting attention, perception, memory and speed along with conventional exercise ( otago exercise program) for 12 sessions spread over 4 weeks. |
| Comparator Agent |
Conventional therapy |
Conventional exercise in the form of Otago exercise program for 12 sessions spread over 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
1. Young old healthy geriatric population.
2. Post covid (6 months) recovered. |
|
| ExclusionCriteria |
| Details |
1.Elderly with any existing musculoskeletal, neurological and other systemic illness that would affect balance.
2.Recently (past 6 months) undergone any back, knee or ankle surgery that would hamper balance.
3.Uncontrolled diabetes and hypertension.
4.Any existing neurodegenerative conditions affecting intellect eg: dementia.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini-BEST scale,
Walking while talking test |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
31/12/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title - COMPARISION OF COGNITIVE TRAINING VERSUS CONVENTIONAL TRAINING ON BALANCE IN GERIATRIC POPULATION Introduction - Aging is an inevitable process which affects structural and functional basis of life. There are 3 types of ageing i.e. primary (associated with chronological age), secondary (disease-related) and tertiary (decremental influences that increase the risk of mortality). Frailty in healthy elderly population is attributed mainly to their sedentary lifestyle, changes in musculoskeletal system with the addition of age-related diseases, hence making it difficult for them to adapt to changing situations. All these changes affect the posture, loss of balance control and hence risk independent mobility and increase frequency of falls. Old adults with no direct cause for risk of fall and living independently will show minimal deficit in balance abilities due to natural process of ageing. Balance is defined as complex interaction of the sensorimotor and central processing system. It is a modifiable aspect with appropriate testing and rehabilitation. Physical, environmental, socio-cultural and genetic factors have their influences on all 3 types of ageing which affect cognition in older population. A decrease in volume of grey matter, an increase in HPA axis activity, deterioration in the sensory system, weakened neuromodulatory control, less indulgence in activities that have cognitive demands during the lifetime have their contribution in deterioration of cognitive abilities in later stages of life. There are fewer studies showing effect of cognitive exercises on balance in older population. Hence including cognitive exercise to conventional exercise may prove beneficial in improving balance of elderly population. Aim - To compare cognitive exercises with conventional exercises on balance in geriatric population. Objectives - 1) To assess the effect of cognitive training on balance in geriatric population using Mini-BEST Scale and Walking While Talking Test. 2) To assess the effect of conventional training (Otago program) on balance in geriatric population using Mini-BEST Scale and Walking While Talking Test. 3) To compare the two groups. |