| CTRI Number |
CTRI/2023/09/057828 [Registered on: 19/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
knee joint pain its and effect on physical actions and risk of fall with different foot arch in elders |
|
Scientific Title of Study
|
Association of physical performance and risk of fall with different foot postures in elderly individuals with osteoarthritis of knee joint a cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi S Zabak |
| Designation |
1st year MPT(community physiotherapy) |
| Affiliation |
Dr Vithalrao Vikhe Patil college of physiotherapy Ahmednagar |
| Address |
Department of Community Physiotherapy Basement Dr Vithalrao
Vikhe Patil college of physiotherapy vilad ghat Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9067030504 |
| Fax |
|
| Email |
siddhi.zabak.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam D Ganvir |
| Designation |
Principal & Professor Department of Community Physiotherapy |
| Affiliation |
Dr Vithalrao Vikhe Patil College of Physiotherapy Ahmednagar |
| Address |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9373566683 |
| Fax |
|
| Email |
shyam.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Physiotherapy DVVPFS College of Physiotherapy Ahmednaga |
|
|
Primary Sponsor
|
| Name |
DVVPFS College of Physiotherapy Ahmednagar |
| Address |
DVVPFS College of Physiotherapy Ahmednagar |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Shyam D Ganvir |
DVVPFS College of Physiotherapy vilad ghat Ahmednagar |
Department of community physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA |
9373566683
shyam.ganvir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
osteoarthritis of knee joint |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants diagnosed with osteoarthritis of knee joint using ACR clinical criteria.
2.Elderly able to walk without assistive device.
|
|
| ExclusionCriteria |
| Details |
1. Any Neurological diseases
2. Individuals with any rheumatic diseases.
3. History of spine or lower-limb surgeries,
4. Recent lower limb fractures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
short physical performance battery test
functional reach test
foot posture index
|
immediately
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
03/10/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low walking speed, mobility restrictions, and difficulties in elders are all known effects of age-related declines in muscle strength and power. However, in osteoarthritis degenerative changes starts to appear and foot posture leads to change in force distribution. This study is aimed to find out association physical performance and risk of fall in elderly individuals with knee joint osteoarthritis which could be beneficial for developing effective fall prevention strategies. |