| CTRI Number |
CTRI/2020/10/028401 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF EXERCISE FOR BACKWARD BALANCE PROBLEM IN ELDERLY POPULATION. |
Scientific Title of Study
Modification(s)
|
EFFECT OF EXERCISE PROTOCOL FOR
BACKWARD DISEQUILIBRIUM IN GERIATRIC
POPULATION: 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 |
SRUTHI MOHAN |
| Designation |
MASTER OF PHYSIOTHERAPY(MPT) STUDENT |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
GROUND FLOOR, ROOM NO 20, NITTE INSTITUTE OF PHYSIOTHERAPY, KS HEGDE MEDICAL SCIENCES COMPLEX, NITTE DEEMED TO BE UNIVERSITY, DERALAKATTE, MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8150830455 |
| Fax |
|
| Email |
sruthimohan407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs SUCHETHA P S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
GROUND FLOOR, ROOM NO 20, NITTE INSTITUTE OF PHYSIOTHERAPY, KS HEGDE MEDICAL SCIENCES COMPLEX, NITTE DEEMED TO BE UNIVERSITY, DERALAKATTE, MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448441292 |
| Fax |
|
| Email |
suchetaps@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SRUTHI MOHAN |
| Designation |
MASTER OF PHYSIOTHERAPY(MPT) STU |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
GROUND FLOOR, ROOM NO 20, NITTE INSTITUTE OF PHYSIOTHERAPY, KS HEGDE MEDICAL SCIENCES COMPLEX, NITTE DEEMED TO BE UNIVERSITY, DERALAKATTE, MANGALORE
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8150830455 |
| Fax |
|
| Email |
sruthimohan407@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Community dwelling elderly population in and around deralakatte.
K.s hegde geriatric day care center, Abhaya Ashraya (Asaigoli) |
|
|
Primary Sponsor
|
| Name |
NITTE DEEMED TO BE UNIVERSITY |
| Address |
6TH FLOOR, UNIVERSITY ENCLAVE, MEDICAL SCIENCES COMPLEX DERALAKATTE, MANGALURU - 575018 KARNATAKA, INDIA 575018 |
| 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 |
| SRUTHI MOHAN |
JUSTICE K S HEGDE HOSPITAL |
ROOM NO. 20,
DEPARTMENT OF
PHYSICAL THERAPY,
DERALAKATTE,
MANGALURU
Dakshina Kannada
KARNATAKA |
8150830455
sruthimohan407@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
BALANCE TRAINING |
1. Standing with back against the wall with heels touching the wall
2. Sitting to standing
3. Standing to sitting
4. Continues stepping
5. Backward stepping
The above exercises will be given for 30 minutes, 3 times in a week(alternative days) for 4 weeks. The progression will be made by increasing the complexity of task.
[7]
Along with the above exercises, general fitness training including Aerobic exercise, Strength training, Flexibility exercises, which is given for the control group will be given for 10 minutes |
| Comparator Agent |
GENERAL FITNESS EXERCISE |
General fitness exercise for 40 minutes, 3 times in a week (alternative days) for 4 weeks.
It includes Aerobic exercise, Strength training, Balance exercises, Flexibility
exercises. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
- Age: 65-74years.
- Both Male and female.
- Mini mental state examination score: >21.
- Backward disequilibrium scale score ranging from 2-10.
- Berg balance score ranging from 21-52 |
|
| ExclusionCriteria |
| Details |
- Musculoskeletal complications effecting ambulation of patients.
- Cardiovascular complications.
- Neurological issues like tremors, akinesia, hypertonia, vertigo.
- People with visual impairments like visual field defect, visual acuity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BACKWARD DISEQUILIBRIUM SCALE |
Outcome measures will be recorded on the first day and at the end of 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BERG BALANCE SCALE |
Outcome measures will be recorded on the first day and at the end of 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2020 |
| Date of Study Completion (India) |
30/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The posture and gait disorders are common among elderly, as age increases
posture and gait disorders also increase. The vestibular, visual, somatosensory
system controls the balance by sending information into the central nervous
system. As age increases there will be impaired performance of all the above
system which leads to balance and postural disorders. One of the conditions
which are seen in elderly is backward disequilibrium.
[6]
Backward disequilibrium, a postural disorder that has severe consequences like
backward fall, imbalance, gait abnormalities etc. This could be improved by early
diagnosis and management using appropriate interventions. Backward
disequilibrium is a less researched area under imbalance.
[4] The main aim of the
study is to find the effect of exercise prescription of individual with backward
disequilibrium. There are no higher evidence studies done to assess the patients
with backward disequilibrium and to find the effect of exercise for its management. |