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CTRI Number  CTRI/2020/01/023048 [Registered on: 30/01/2020] Trial Registered Prospectively
Last Modified On: 24/01/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Influence of age and sex on wrist joint position sense in healthy individuals 
Scientific Title of Study   Influence of age, gender and dominance on wrist proprioception in healthy individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Kavitha Vishal 
Designation  Assistant Professor (Senior Scale) 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Manipal College of Health Professions, Manipal Dr, Madhav Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9986526077  
Fax    
Email  kavithavishal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saidan Shetty 
Designation  MPT student 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Saisagar, Post Halladi- Harkadi, Kundapur taluk, Udupi district,PIN code 576210 Karnataka State, India

Udupi
KARNATAKA
576210
India 
Phone  9008858059  
Fax    
Email  saidanshetty1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Kavitha Vishal 
Designation  Assistant Professor (Senior Scale) 
Affiliation  Manipal College of Health Professions, Manipal 
Address  Manipal College of Health Professions, Manipal Dr, Madhav Nagar, Manipal, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9986526077  
Fax    
Email  kavithavishal@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Saidan Shetty 
Address  Saisagar, Post Halladi-Harkadi, Kundapur taluk, Udupi district, PIN 576210 Karnataka State, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 
Mrs Kavitha Vishal  Kasturba Hospital  Kasturba Hospital, Department of Physiotherapy, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9986526077

kavithavishal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals between age group of 18 to 40 years, of either gender will be recruited. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Healthy individuals between the age group of 18 to 40 years, of either gender. 
 
ExclusionCriteria 
Details  Individuals who had any previously diagnosed wrist and hand pathologies like fractures, open wounds, etc. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Wrist Proprioception using Active Wrist Joint Position Sense test  Baseline only 
 
Secondary Outcome  
Outcome  TimePoints 
Hand Function using Moberg Pick Up Test  Baseline only 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/02/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Proprioception is the perception of movement, posture and joint position. Several factors influence proprioception in healthy individuals. Wrist sensorimotor disturbances of the wrist has been implicated as a risk factor in several wrist pathologies. However, there has been limited literature to identify factors that may influence it. Purpose of the study is to find the effect of age, gender and hand dominance on wrist proprioception, and its relation with hand function in healthy individuals. Healthy individuals between the age group of 18 to 40 years, of either gender will be included and individuals who had any previously diagnosed wrist and hand pathologies like fractures, open wounds etc will be excluded in the study. 
Wrist proprioception will be assessed using Active wrist joint position sense test. Goniometer will be used to measured the wrist angles. Participant will be shown reference wrist position with eyes closed by moving the wrist into 20 degree flexion. Angle will be memorized. Participant will be asked to reproduce the 20 degree flexion angle and it will be measured. Difference between two angles will be used as the joint position sense deficit criterion value. This same procedure will be applied with 20 degree wrist extension. This will be measured of both the hands. Mean of three trials will be recorded for both flexion and extension. Hand function will be assessed using Moberg Pickup test. The participant has to pick 12 small metallic objects and transfer them to a small container. Mean of 3 trials will be taken. This will be done with eyes open and eyes closed, of both the hands. SPSS version 16 will be used for data analysis. Descriptive statistics will be followed for demographic data like age, gender, hand dominance etc. Statistical analysis will be done using Pearson’s or Spearman’s Correlation Coefficient to find the correlation of age, gender and hand dominance, with wrist proprioception and hand function in healthy individuals. 
The influence will help us understand the differences in wrist proprioception between genders and across age groups. Theses differences will help us design better preventive and rehabilitative strategies to address the deficits.
 
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