FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/07/014878 [Registered on: 16/07/2018] Trial Registered Prospectively
Last Modified On: 11/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Is calf muscle strength a predictor of risk of falls in elderly? 
Scientific Title of Study   Can Plantar Flexor strength predict risk of falls in elderly? 
Trial Acronym  CPFSPROFIE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Payal Shetkar 
Designation  PG student 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy, 1st floor, 11/12 Thube park, Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9673295038  
Fax    
Email  shetkarpayal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrGajanan Bhalerao 
Designation  Professor 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy,1st floor, 11/12 Thube park, Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9822623701  
Fax    
Email  gajanan_bhalerao@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrGajanan Bhalerao 
Designation  Professor 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy,1st floor, 11/12 Thube park, Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  9822623701  
Fax    
Email  gajanan_bhalerao@yahoo.com  
 
Source of Monetary or Material Support  
Payal Shetkar Sancheti Institute College of Physiotherapy, Sancheti Healthcare academy, 1st floor, 11/12 Thube park, Shivajinagar, Pune 411005  
 
Primary Sponsor  
Name  sancheti institute college of physiotherapy 
Address  Sancheti Institute College of Physiotheraspy, Sancheti Healthcare academy, Thube Park 1112, Shivajinagar, Pune 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Payal Shetkar   Old age home, Community dwelling eldery of pune city  Pune city
Pune
MAHARASHTRA 
02028999713

shetkarpayal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Sancheti Institute for Orthopaedics and Rehabilitation,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Geriatric Individuals between 60 to 80 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Males and Females in the age group of 60 to 80years.
2.Walking atleast 10 meters.
 
 
ExclusionCriteria 
Details  1. Any cardiovascular, musculoskeletal involvement severe enough to affect ambulation.
2. Central nervous system pathology.
3. Visual impairment (blindness, cataract causing severe visual challenge wherein basic ADLs are difficult),
4. Auditory impairment (should be able to hear instructions correctly, with or without hearing Aid),
5. Cognitive impairment (MMS < 24)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Plantar flexor strength: Micro-FET HHD
2. Dorsiflexion ROM: Weight bearing lunge test
3. Case record: Fall risk assessment tool(FRAT)
4. Dynamic balance: TUGT
5. Anthropometric measures: BMI
6. Physical activity level: PASE
 
one time assessment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/08/2018 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

CAN PLANTAR FLEXOR STRENGTH PREDICT FALLS IN THE ELDERLY?

Introduction

India is the most populous country having over 104 million elderly persons (aged 60 and above) constituting about 8.6% of the total population in India. The old age dependency ratio increased to 14.9% and 13.6% in males and females respectively in 2011(1). One of the main reasons why this huge number becomes dependent is ‘falls’. Falls are one of the major problems in the elderly and hence are considered as one of the “Geriatric giants”

Every year accidental falls occur in nearly one-third of those aged more than 60 years, with 10% of these falls resulting in serious injury(2). Loss of balance and falls in the elderly constitute a major problem associated with human suffering as well as high costs for society(3).

But, falls that do not lead to injury often begin a downward spiral of fear that leads to inactivity and decreased strength, agility and balance that often results in loss of independence in normal activities of self-care(4). With the growing aging population, the number of falls will likely increase in coming years. Therefore, there it is necessary to develop and implement low cost, time-efficient, exercise intervention programs targeting particular muscle groups in order to increase strength, functional mobility and balance in older adults and, subsequently, to decrease the risk of falls(5).

Hence, finding all the variables influencing the risk of falls in the elderly is essential.

Ageing is associated with reduced muscle strength(6).  The age-related modifications on motor system can be viewed as examples of an inevitable, genetically programmed process that causes both decline and physiological adaptation in neuromuscular function. These modifications, involving the loss of cells, lead to the reduction in complement of motor neurons and muscle fibres, inducing, in turn, the reduction of muscle mass and strength, especially in the lower limbs(7).

Amongst the lower limb muscles, the ratio of muscle strength to muscle thickness in the elderly group was significantly lower than that in the young group in plantar flexors (p<0.001), but not in knee extensors(8).  The strength of ankle plantar flexors (PF) is related to mobility functions of older adults(9). The ankle PF provides stability for the weight-bearing limb and allows for advancement of the swinging limb in both walking and stair climbing tasks(10, 11). However, when all 4 muscle groups were considered together, only the PF muscle performance (repeated heel-rise ability) showed a significant association with all 3 mobility tasks. The importance of PF muscle performance in lower extremity ambulation activities has been emphasised(9, 10, 11). The PF is also a significant predictor of postural control(9) and balance(12)  in community dwelling older persons.

The mobility requirements for ankle DF during gait and balance are primarily weight-bearing related(13). There is decrease in ankle joint range of motion with increasing age and this affects balance also(14). Ankle dorsiflexion measured with weight bearing methods resulted in a significant correlations for balance in the older age group(13)

Balance is strongly associated with falls in the elderly. The TUG is a simple and inexpensive tool that was developed to screen functional mobility(15). Within research, the use of the TUG has increased over the last few years, and it is recommended by several geriatric societies when screening for risk of falling.(16), (17)

Thus considering all these factors, this study aims to form a predictive model with these variables (Plantar flexor strength, Dorsiflexion ROM), wherein contribution of each variable to the risk of fall will be identified and thus can be used in the intervention to delay their risk of falls.

AIM:

To find out the contribution of Plantar flexor strength to the risk of falls in the elderly

OBJECTIVE:

1.      To assess TUG performance and classify the subjects into fallers or non-fallers group depending on their TUG score.

2.      To assess Plantar flexor strength, dorsiflexion ROM, Fall risk assessment tool(FRAT), Physical activity scale in elderly (PASE) in the subjects.

3.      To find the contribution of plantar flexor strength, dorsiflexion ROM, Fall risk assessment tool(FRAT), Physical activity scale in elderly (PASE) to the risk of fall in the elderly.

Methodology:

STUDY DESIGN: Cross-sectional- Analytical study

STUDY POPULATION: Community dwelling elderly

SAMPLING TECHNIQUE: Quota sampling

SAMPLE SIZE: 70

INCLUSION CRITERIA:

1.      Males and Females in the age group of 60 to 80years.

2.      Walking atleast 10 meters.

EXCLUSION CRITERIA:

1.      Any cardiovascular, musculoskeletal involvement severe enough to affect ambulation.

2.      Central nervous system pathology.

3.      Visual impairment (blindness, cataract causing severe visual challenge wherein basic ADLs are difficult),

4.      Auditory impairment (should be able to hear instructions correctly, with or without hearing Aid),

5.      Cognitive impairment (MMS < 24)

OUTCOME MEASURES:

1. Plantar flexor strength: Micro-FET HHD

2.      Dorsiflexion ROM: Weight bearing lunge test

3.      Case record: Fall risk assessment tool(FRAT)

4.      Dynamic balance: TUGT

5.      Anthropometric measures: BMI

6.      Physical activity level: PASE

Record of co-morbidities

PROCEDURE:

•         After the approval from the ethical committee, the subjects will be explained about study and a written informed consent will be taken.

•         The subjects will be assessed for (1) Plantar flexor muscle strength (predictor variable) (2) Dorsiflexion range and PASE (predictor variable), BMI, FRAT. The subjects will be instructed to perform TUG (outcome variable).

•         The subjects will be divided into two groups: Fallers and non-Fallers depending on their TUG score.

•         A logistic regression will be conducted to predict the likelihood of belonging to the fallers v/s non-fallers group, using the predictor variables of plantar flexor strength, dorsiflexion ROM, PASE and BMI.

 
Close