| CTRI Number |
CTRI/2021/07/035314 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of wrist proprioception in healthy adults |
|
Scientific Title of Study
|
Comparison of Wrist Proprioception, Grip and Pinch strength in Adults with and without Generalized Joint Hypermobility. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANIYA SHAILESH PRADHAN |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals, MAHE, Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9284167880 |
| Fax |
|
| Email |
pradhan.shailesh@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavitha Vishal |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals, MAHE, Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Vishal |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals, MAHE, Manipal- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professionals, MAHE, Manipal -576104 |
|
|
Primary Sponsor
|
| Name |
Saniya Pradhan |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals, MAHE, Manipal -576104 |
| Type of Sponsor |
Other [Self-Funded] |
|
|
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 |
| Saniya Pradhan |
Kasturba Hospital |
Kasturba Hospital,Madhav Nagar, Tiger Circle, Manipal -576104.
Udupi
KARNATAKA |
9284167880
pradhan.shailesh@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Generalized Joint Hypermobility |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Eligibility criteria – for GJH group
Inclusion criteria:
1. Adults (18-40 years)
2. Either gender
3. With Beighton score more than or equal to 5/9
4. Wrist flexion and extension ROM >90 degrees.
Eligibility criteria – for reference group
Inclusion criteria:
1. Adults (18-40 years)
2. Either gender
3. With Beighton score less than 5/9
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for both the groups:
1. Recent history of trauma in the upper extremity or neck
2. Recent history of surgery in the upper extremity or neck
3. Pain in the upper extremity or neck region
4. Open wounds/ skin injuries/ oedema over wrist or hand
5. Rheumatoid disease of wrist or hand
6. History of any neurological condition
7. Impaired cognition
8. Diagnosed with DM
9. Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wrist joint proprioception in mean absolute error in degrees |
one time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2021 |
| Date of Study Completion (India) |
30/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
This is an observational study to compare the wrist joint proprioception , grip and pinch strength in adults with and without generalized joint hypermobility. The aim is to determine if there is any difference present between the wrist proprioception, grip, and pinch strength in individuals with and without generalized joint hypermobility. Participants will be seated on a chair without an armrest and their wrist joint proprioception will be measured using active wrist joint position sense test thrice and the mean of it will be considered. The outcome here is the mean of absolute error in active repositioning. Values will be compared for both the populations. |