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CTRI Number  CTRI/2022/11/047442 [Registered on: 18/11/2022] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment and comparison of sensorymotor function, reaction time and hand function in diabetic and non-diabetic older adults 
Scientific Title of Study   Assessment of sensorymotor function, reaction time and hand function in older adults and comparison of sensorymotor function, reaction time and hand function in diabetic and non-diabetic older adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagyashree Kamble 
Designation  Assistant Professor 
Affiliation  Terna Physiotherapy college 
Address  Terna physiotherapy college, third floor of terna medical college, sector 12, near sarsole depot , nerul west 400706

Thane
MAHARASHTRA
400706
India 
Phone  09833700488  
Fax    
Email  bhagyashreekamble@ternapt.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Saraswati Iyer 
Designation  HOD & Professor 
Affiliation  PT school ¢re, Seth GSMC & kEMH 
Address  PT school and centre, Seth GSMC and KEMH, Parel mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  9sarasiyer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhagyashree Kamble 
Designation  Assistant Professor 
Affiliation  Terna Physiotherapy college 
Address  Terna physiotherapy college, third floor of terna medical college, sector 12, near sarsole depot , nerul west 400706

Thane
MAHARASHTRA
400706
India 
Phone    
Fax    
Email  kbha39@gmail.com  
 
Source of Monetary or Material Support  
Terna Physiotherapy college and hospital 
 
Primary Sponsor  
Name  Dr Bhagyashree Kamble 
Address  Terna physiotherapy college, third floor of terna medical college, sector 12, near sarsole depot , nerul west 400706 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Saraswati Iyer  PT school& centre, seth GSMC & KEMH, parel ,Mumbai 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhagyashree kamble  Terna hospital and research centre  Physiotherapy OUT PATIENT DEPARTMENT and IPD patients
Thane
MAHARASHTRA 		 09833700488

bhagyashreekamble@ternapt.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  geriatrics  
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  - Patients having musculoskeletal problem other than neck, shoulder,
elbow and wrist
- montreal coagnitive assessment score more than 26 (MOCA score )
- wrist and hand pain less than 4 on VAS 
 
ExclusionCriteria 
Details  Any skin injury, an open wound posing a risk of infection,
• Deformities in the upper extremity following a rheumatic disease,
a neurological disease, an orthopaedic problem in the hand and
wrist
• severe mental and cognitive problem.
• Untreated Vision problem and auditory problem
• Chronic alcoholic
• Pain radiating / referred from cervical region
• Fixed deformities of the hand 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
hand dexterity by using 9 hole peg test
❑ sensory threshold by using Semmes Weinstein Monofilament Test
❑ e hand grip strength by using jamar hydraulic hand dynamometer
❑ hanD function by using Michigan hand function scale
❑ reaction time by DearyLiewald paradigm  		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
hand grip strength by using jamar hydraulic hand dynamometer
❑ hanD function by using Michigan hand function scale
❑ reaction time by DearyLiewald paradigm  		 1 year 
 
Target Sample Size   Total Sample Size="670"
Sample Size from India="670" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="670" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) 30/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The hand is the most active and important part of the upper extremity. The combination of motor and sensory parameters of the hand are important for executing movements of daily activities. Hands undergo many physiological and anatomical changes associated with aging. The effect of normal aging on hand in older adults are still poorly understood. With advanced age incidence of diabetes also increases. Hand complications in patients with diabetes may affect daily activities, disabilities in selfcare and increase in dependency. The purpose of the study is to find sensory motor function, reaction time and hand function in diabetic and non-diabetic older adults. This will be a prospective study. Subjects will be taken as per inclusion and exclusion criteria. total 670 participants will be recruited in this study. Following Outcome measures are used – 9 hole peg board (Hand Dexterity) , Jamar hand dynamometer (Hand Grip strength) , semmesWeinstein monofilament (Sensory Threshold), Deary-liewald paradigm(Reaction time) , Michigan hand function scale (Hand function scale) 
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