| CTRI Number |
CTRI/2021/02/031596 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Reaction Ball Training on processing speed, language ,learning ,reasoning ,remembering, problem solving ,decision making ,and attention in diabetic individuals |
|
Scientific Title of Study
|
Effect of Reaction Ball Training on Cognitive Function in Type 2 Diabetic population -A Pre Post Experimental Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeba Chitra |
| Designation |
Head of department of Neurology Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Neurology Physiotherapy, Physiotherapy Department, KLE Prabhakar Kore Hospital,Nehru Nagar, Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
7760984968 |
| Fax |
|
| Email |
jebachitra@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeba Chitra |
| Designation |
Head of department of Neurology Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Neurology Physiotherapy, Physiotherapy department, KLE Prabhakar Kore Hospital, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7760984968 |
| Fax |
|
| Email |
jebachitra@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Ghadi |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Neurology Physiotherapy, Physiotherapy department, KLE Prabhakar Kore Hospital, Nehru Nagar, Belgaum.
Belgaum
KARNATAKA
590010
India |
| Phone |
7760984968 |
| Fax |
|
| Email |
prachighadi100@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Prabhakar Kore Hospital and Medical Research Center, Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE university |
| Address |
KAHER Institute of Physiotherapy ,nehru nagar , Belgaum |
| 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 |
| Prachi Ghadi |
KLE Hospital |
Neurology Physiotherapy, Nehru Nagar. Belgaum
Belgaum
KARNATAKA |
7760984968
prachighadi100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical review committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
type 2 diabetic population |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Reaction ball Training on type 2 diabetic population |
Reaction ball is a six sided high intensity ball which is used for training and has been proved effective in improving reaction time and eye hand coordination .This is a pre post study with a single intervention that is reaction ball training. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants with type 2 diabetes since last 4 years
Participants in the age group of 40-65 years |
|
| ExclusionCriteria |
| Details |
Participants with any injury to upper limb and lower limb.
Participants with any other neurological conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Montreal cognitive assessment scale , 6 item cognitive assessment |
Before Intervention and After Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
20/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is a condition where different complications are seen and decline in the cognitive function is one of them .After age 40 in diabetes there is cognitive decline seen which is reduction in awareness , recollection , speech , discrimination , decision making , problem solving , and processing speed .There are various exercises done for improving cognitive function and exercises with reaction ball my also be helpful .The reason we are doing this study is to evaluate if training with reaction ball improves cognitive function in type 2 diabetic population. |