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
|
|
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
|
|
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
|
|
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. |