| 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
|
|
|
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
|
|
|
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
|
|
|
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. |