| CTRI Number |
CTRI/2024/02/062879 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| 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
|
Effect of Brain Gym Exercises on gait parameters and QOL in elderly population |
|
Scientific Title of Study
|
Effect of Brain Gym Exercises on gait parameters 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 |
Pandya Krishna Rushikesh |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room No 01
Division Exercise Therapy
Department Physiotherapy
Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
7359770776 |
| Fax |
|
| Email |
krpandya1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Suthar |
| Designation |
Lecturer, PhD. and PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room No 01
Division Exercise Therapy
Department Physiotherapy
Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
9913806872 |
| Fax |
|
| Email |
vaishu82in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Suthar |
| Designation |
Lecturer, PhD. and PG Guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room No 01
Division Exercise Therapy
Department Physiotherapy
Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060
GUJARAT
380060
India |
| Phone |
9913806872 |
| Fax |
|
| Email |
vaishu82in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Insitute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Pandya Krishna Rushikesh |
| Address |
Ahmedabad Institute of Medical Sciences
AIMS Campus, Nr S.P. Ring Road, Ognaj circle, Nr. Lions Karnavati Eye Hospital, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060 |
| 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 Vaishali Suthar |
Ahmedabad Institute of Medical Sciences |
Room No 01
Division Exercise Therapy
Department Physiotherapy
Ahmedabad Institute of Medical Sciences, Nr S.P. Ring Road, Ognaj circle, Gota-Kalol Highway, Lapkaman, Ahmedabad - 380060
Ahmadabad
GUJARAT |
9913806872
vaishu82in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatrics |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercises |
3 days a week for 2 weeks |
| Comparator Agent |
Conventional Exercises |
3 days a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
84.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 65 to 84 years
2. Gender—male and female both
3. MMSE score ≥ 24
4. BBS score ≥ 41/56
5. Subjects willing to participate in study |
|
| ExclusionCriteria |
| Details |
1. History of any neurological and musculoskeletal impairment, balance impairment like CVS, Parkinson disease and fractures.
2. Unstable cardio-respiratory condition that may affects training procedure.
3. Patient diagnosed with severe visual and auditory impairment.
4. Patient walking with external aids.
5. Cognitive impaired subjects. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stride Length, Cadence and Gait Velocity |
Baseline and at the end of 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Older People Quality of Life Scale |
Baseline and at the end of 2nd week |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim Of The Study
The aim of the study is to determine the effect of brain gym exercises on gait parameters and quality of life in elderly population. Objectives - To study the effect of brain gym exercises on gait parameters in elderly population.
- To study the effect of brain gym exercises on stride length in elderly population.
- To study the effect of brain gym exercises on cadence in elderly population.
- To study the effect of brain gym exercises on gait velocity in elderly population.
- To study the effect of brain gym exercises on quality of life in elderly population
|