| CTRI Number |
CTRI/2021/03/032084 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between Hand function and cognition in patients with Diabetic Polyneuropathy |
|
Scientific Title of Study
|
Association between Manual dexterity and Domain Specific cognition in subjects with Diabetic Polyneuropathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 19HM003 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumeeta PM |
| Designation |
Post-Graduate Student |
| Affiliation |
College of Physiotherapy, Dayananda Sagar University |
| Address |
College of Physiotherapy,
Dayananda Sagar University,
Shavige Malleshwara Hills,
Kumaraswamy Layout,
Bangalore
Bangalore
KARNATAKA
560111
India |
| Phone |
09986384843 |
| Fax |
|
| Email |
mesumeeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Hari Sharma |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Dayananda Sagar University |
| Address |
College of Physiotherapy,
Dayananda Sagar University,
Shavige Malleshwara Hills,
Kumaraswamy Layout,
Bangalore
Bangalore
KARNATAKA
560111
India |
| Phone |
9886040520 |
| Fax |
|
| Email |
srihari-physio@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sumeeta PM |
| Designation |
Post-Graduate Student |
| Affiliation |
College of Physiotherapy, Dayananda Sagar University |
| Address |
College of Physiotherapy,
Dayananda Sagar University,
Shavige Malleshwara Hills,
Kumaraswamy Layout,
Bangalore
KARNATAKA
560111
India |
| Phone |
09986384843 |
| Fax |
|
| Email |
mesumeeta@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Dayananda Sagar University |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy Dayananda Sagar University |
| Address |
Shavige Malleshwara Hills,
Kumaraswamy Layout,
Bangalore 560111 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Nandhini S |
Karnataka Institute of Endocrinology and research |
Bannerghatta Main Road, Near Jayadeva Hospital, Phase 3 ,9th block , Jayanagar , Bangalore 560069
Bangalore
KARNATAKA |
9972036965
nandusgowda18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe , Dayananda Sagar University |
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
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Diabetic Polyneuropathy by a Podiatrist
Ability to see with glasses
|
|
| ExclusionCriteria |
| Details |
History of stroke
Use of antiepilepric medications , neurotropic agents or psychotropic agents that could interfere in the cognitive tests
Glycated haemoglobin (A1c) level below 4.0%
Known neurodegenerative diseases like Parkinson’s Disease or Alzheimers Disease, MND , Spinal Muscular Atrophy etc
Orthopaedic disorders of upper limb that can affect manual dexterity : Cervical pathology, Shoulder pathology etc
Diabetic retinopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nine Hole Peg Test for Manual Dexterity |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Montreal Cognitive Assessment ( MoCA) for Domain Specific Cognition |
One time |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2021 |
| Date of Study Completion (India) |
01/06/2021 |
| 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
|
Association between Manual Dexterity and Domain Specific Cognition in subjects with Diabetic Polyneuropathy. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.Type 2 Diabetes Mellitus subjects present with various sensory deficits, balance issues and foot ulcers as well. A lot of studies have been done with regard to improving balance and mobility but very less studies have explored the effect of cognition in the type 2 DPN subjects.
The incidence of neurodegenerative diseases associated with age is increasing. Cognitive dysfunction in individuals with diabetes can result from interactions between inherent metabolic abnormalities , such as hyperglycemia, hyperinsulinaemia, and micro and macrovascularcomplications in addition to hypertension , dyslipidemia , depression and obesity.
2. Upper limb function is one of the strong indicators of quality of life in the T2DM population as .Dexterity is that trait in humans that determines hand function. Thus it seems necessary to understand the impact of neurodegeneration on hand dexterity & hand function which are very essential while executing everyday functional activities.
Manual dexterity measures can be useful for early detection of age related functional decline.
|