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CTRI Number  CTRI/2021/06/034491 [Registered on: 30/06/2021] Trial Registered Prospectively
Last Modified On: 19/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Correlation of Strength Balance with Functional Ability among Elderly Patients with Leg Problems 
Scientific Title of Study   Correlation of Strength and Dynamic Balance with Self-Reported Functional Ability among Elderly Population with Lower Extremity Dysfunctions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Paranjape 
Designation  Assistant Professor 
Affiliation  Physiotherapy Department, Seth G S Medical College, KEM Hospital 
Address  402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  02224107000  
Fax    
Email  swati.paranjape@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Swati Paranjape 
Designation  Assistant Professor 
Affiliation  Physiotherapy Department, Seth G S Medical College, KEM Hospital 
Address  402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  02224107000  
Fax    
Email  swati.paranjape@kem.edu  
 
Details of Contact Person
Public Query
 
Name  Vaishnavi Shinde 
Designation  Post Graduate Student 
Affiliation  Physiotherapy Department, Seth G S Medical College, KEM Hospital 
Address  402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  02224107000  
Fax    
Email  vaishnavishinde222@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy Department, Seth G S Medical College, KEM Hospital 
 
Primary Sponsor  
Name  Nil 
Address  NA 
Type of Sponsor  Other [Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Swati Paranjape  Seth G S Medical College, KEM Hospital  402, Physiotherapy Department, Seth G S Medical College, Dhurmal Bajaj Orthopaedic Centre, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
02224107000

swati.paranjape@kem.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee, IEC- III; For Biomedical and Health Research; Seth G S Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Above 60 years of age willing to participate in the study

2. Patients with unilateral or bilateral lower limb disorders with established diagnosis:
- Hip, Knee, Ankle joint disorders
- Total Hip Arthroplasty/Total Knee Arthroplasty
- Lower extremity fractures
- Soft tissue and connective tissue disorders of lower limb
3. Subacute and chronic cases with symptoms for more than 3 months
4. VAS score: between 1 to 6
5. Patients with musculoskeletal congenital defects
 
 
ExclusionCriteria 
Details  1. Patients with spinal pathology affecting lower extremities
2. Radiating pain to lower extremity
3. Any congenital or acquired neurological condition (stroke, cerebral palsy, neural tube defects, upper or lower motor neuron lesions, spinal cord injuries, post-polio residual paralysis, etc)
4. Vestibular disorders
5. Uncorrected visual impairments
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Lower Extremity Functional Scale(LEFS) score
2.30 Second Chair Stand Test (number of full chair stands)
3.8-Foot Up and Go Test (time in seconds)
 
Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   30/07/2021 
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)   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)?  

Response - NO
Brief Summary  

Musculoskeletal conditions of lower extremities are the most common cause of impairments and disabilities in elder population. With increasing age, disability increases and also physical performance reduces. Limited studies have been found on elderly in Indian population identifying the correlation of physical performance like strength and dynamic balance with their functional ability. Studies have reported reduction in functional ability in elderly after COVID lockdown. Few studies were found to report weak correlation between self-reported functional ability and objectively assessed physical performance whereas some studies showed strong correlation between the two. Inconsistent study results and the gap in the knowledge about the perception of the functional ability and actual physical performance in elderly makes it necessary to find out the correlation of self-reported functional ability with objective assessment of physical performance in elderly with lower limb dysfunctions especially in this COVID era. After the approval from the ethical committee, this cross sectional study with purposive sampling will be carried out. Participants with both unilateral and bilateral lower limb dysfunctions will be included as per inclusion-exclusion criteria. Written informed consent will be taken prior to commencement of the study from the patient. They will be instructed to fill a self-reported Lower Extremity Functional Scale(LEFS) to assess their functional ability. For physical performance they will be assessed for lower limb strength(using 30 Seconds Chair Stand Test) and dynamic balance(using 8 Foot Up and Go Test). Data obtained from these tests will be analysed for correlation between functional ability (LEFS score) with strength(number of full chair stands) and dynamic balance( time in seconds) using Pearson’s correlation coefficient. Extent of correlation(if any) will be carried out with regression analysis. 

 
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