| CTRI Number |
CTRI/2024/09/073702 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| 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
|
COMPARE THE EFFECT OF BRAIN GYM EXERCISE AND SQUARE STEPPING EXERCISE IN DIABETC NEUROPATHY PATIENTS. |
|
Scientific Title of Study
|
COMPARE THE EFFECT OF BRAIN GYM EXERCISE AND SQUARE STEPPING EXERCISE ON BALANCE AND QUALITY OF LIFE IN INDIVIDUALS WITH DIABETIC NEUROPATHY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TANVI MANISHBHAI KANAKIYA |
| Designation |
PURSUING MASTERS OF PHYSIOTHERAPY IN NEUROSCIENCES |
| Affiliation |
AHMEDABAD INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 001 Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India
Ahmadabad
GUJARAT
380060
India |
| Phone |
9727662253 |
| Fax |
|
| Email |
kanakiyatanvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr 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 |
Dr 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 |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute of Medical Sciences
TANVI MANISHBHAI KANAKIYA |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Institute Of Medical Sciences |
| Address |
Room no 001 Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060 |
| 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 |
| Dr Vaishali Suthar |
Ahmedabad institute of medical Sciences |
Room no 001 Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Nr S P Ring Road Ognaj Circle Gota Kalol Highway Lapkaman Ahmedabad Gujarat India 380060
Ahmadabad
GUJARAT |
9913806872
vaishu82in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercise with conventional treatment |
thrice in a week for 2 weeks |
| Comparator Agent |
Square Stepping Exercise with conventional treatment |
thrice in a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual with both type 1 and type 2 Diabetes Mellitus.2. Individuals with diagnosed Diabetic Neuropathy and through Michigan Neuropathy Screening Instrument Scale. 3. MMSE greater than or equal to 24. 4. Individuals who can walk independently and without any External aids.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with severe Neurological, cardiopulmonary, and musculoskeletal disorders.
2.Individuals with cognitive, visual and auditory impairments.3.Individuals with high risk of fall according to Berg balance scale. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
at baseline and at end of 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nottingham Health Profile scale |
at baseline and at end of 2 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Applicable |
| 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
|
Aim of the Study The aim of the study is to analyze and compare the effect of Brain Gym Exercise and Square Stepping Exercise on Balance and Quality of Life in individuals with Diabetic Neuropathy.
Objectives of the Study - To find out the effect of Brain Gym Exercise on Balance in individuals with Diabetic Neuropathy by Berg Balance Scale [BBS]
- To find out the effect of Brain Gym Exercise on Quality of Life in individuals with Diabetic Neuropathy by Nottingham Health Profile [NHP]
- To find out the effect of Sqaure Stepping Exercise on Balance in individuals with Diabetic Neuropathy BY Berg Balance Scale [BBS]
- To find out the effect of Square Stepping Exercise on Quality of Life in individuals with Diabetic Neuropathy by Nottingham Health Profile Scale [NHP]
- To compare the effect of Brain Gym Exercise on Balance with Square Stepping Exercise in individuals with Diabetic Neuropathy by Berg Balance Scale [BBS]
- To compare the effect of Brain Gym Exercise on Quality of Life with Square Stepping Exercise in Individual with Diabetic Neuropathy by Nottingham Health Profile [NHP]
|