| CTRI Number |
CTRI/2024/08/072867 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| 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
|
Effective Balance Exercises to Enhance Stability in Older Adults |
|
Scientific Title of Study
|
A Comparative Study and Conventional Balance Exercise With Visual and Auditory Stimulus Versus Cognitive Dual Task Training on Balance In Geriatrics |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha chauhan |
| Designation |
Post Graduation Student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room No. 4, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9368686442 |
| Fax |
|
| Email |
akanksha9520@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anirban Patra |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences |
| Address |
Room No. 4, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8126657833 |
| Fax |
|
| Email |
anirbanpatra17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anirban Patra |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences |
| Address |
Room No. 4, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8126657833 |
| Fax |
|
| Email |
anirbanpatra17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Para Medical and Allied Health and Sciences,
Pathribag, Dehradun, Uttaranchal. 248001
|
|
|
Primary Sponsor
|
| Name |
Akanksha Chuahan |
| Address |
Room no. 3, Physiotherapy department. Shri Guru Ram Rai
University, School of Paramedical and Allied Health and Sciences,
Pathribag, Dehradun, Uttaranchal. 248001 |
| Type of Sponsor |
Other [self] |
|
|
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 Anirban Patra |
Shri Mahant Indiresh Hospital |
Department of
Physiotherapy, North
Block Basement, Shri
Mahant Indiresh
Hospital, Dehradun
Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL |
8126657833
anirbanpatra17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE (IEC) SHRI GURU RAM RAIO INSTITUTE OF MEDICAL AND HEALTH SCIENCE |
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
|
| Type |
Name |
Details |
| Intervention |
cognitive dual task training |
Performed to improve the balance and cognitive function and enhance daily life functionality and reduce fall risk
duration of session 30 35 minutes 4 to 5 session per weel for 6 week |
| Comparator Agent |
coventional balance exercise |
performed for standardized training program and improve balance and stability and reduce fall risk.
duration of session 30 to 35 minutes 4 to 5 session per week for 6 week
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A geriatric patient suffering from balance disturbance is able to stand independently for at least 1 minute, as assessed using the Berg Balance Scale.
|
|
| ExclusionCriteria |
| Details |
The patient has musculoskeletal injuries, fixed contractures or deformities, comorbidities, a neurological condition, impaired cognitive function, and visual and auditory impairments, making them unable to give informed consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BERG balance scale
ABC (ACTIVITIES BALANCE CONFEDENCE SCALE) |
1 Week, 6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ABC Scale |
1 Week, 6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A comparative study of convention balance exercise with visual and auditory stimuli v/s cognitive dual task training on balance in geriatrics. this study compare two balance training method for geriatrics conventional balance exercise with visual and auditory stimuli, and cognitive dual task training , convention balance exercise focuses on physical balance exercise white cognitive dual task training add cognitive task to challenge both body and mind. the study aim to determine which approach improve balance ,cognitive function and daily life functionality in geriatrics. |