RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / Name of the Candidate
and Address /
HARDIK J. PAREKH.
SRINIVAS COLLEGE OF PHYSIOTHERAPY, AND RESEARCH CENTER.
PANDESHWARA,
MANGALORE-575001.
2 /

Name of the Institute

/ SRINIVAS COLLEGE OF PHYSIOTHEPY AND RESEARCH CENTER, MANGALORE
3 /

Course of Study and

Subject / Master of Physiotherapy (MPT)
2 years Degree Course
“ Neurological and Psychosomatic disorders ”
4 /

Date of Admission

To Course /
27/05/09
5 /

Title of the Topic

/ “A Study To Determine The Concurrent Validity Of Falls Efficacy Scale- International
(FES-I) In Elderly Population”
6
7.
8. /
Brief resume of the intended work:
6.1 Need of the Study:
Aging is the life long process of growing older at cellular, organ or whole body level throughout life span1.
Because of the aging process various changes occur in musculoskeletal and neuromuscular system, such as weakness of muscles, decreased range of motion, less spinal mobility leading to changes in quiet stance and changes in motor strategies during perturbed stance.2
Normal age-related physiological changes contribute to both falling and fall risk3. Falls are among the most serious of geriatric problems, causing considerable mortality, morbidity, immobility.4
Fall can be defined as “A sudden, unintentional loss of balance leaves the individual in contact with the floor or another surface such as a step or chair”5.
Falls are usually caused by the interaction of many factors, including environment, past experiences, proprioception, coordination, cognition, vision, vestibular, judgement, cardiovascular condition and other factors in elderly population.6
Falls occur when an individual engages in an activity that results in a loss of balance and the body mechanisms responsible for compensation fail. In older people, falls often occurs during routine activities, such as walking; descending or climbing steps; transferring on/off chair , bed, toilet, or in and out of bath tub; and reaching up or bending down.3
With the aging of the population, the incidence of falls and fall-related injuries is expected to rise7. It is the sixth leading cause of death in people aged 65 and above6. Approximately 33% of people over the age of 65 fall at least once a year, as do approximately 50% of people over the age of 85. In addition, falls continue to be the leading cause of injury in the elderly and also 20% to 60% of people who fall lose their independence.7
Falls are a threat to quality of life and independence that is secondary to impaired mobility and loss of function and thus leading to fear of falling in elderly people. But, developing a fear of falling is not only limited to individuals with a history of falls. Thus, early identification, prevention and intervention for elderly individual who are at risk of fall is becoming increasingly important in the fields of physical therapy and rehabilitation.5, 7
A few authors have avoided the term “fear” and have focused on the “person’s loss of confidence” in balance and walking. Efforts to measure “fear of falling” have focused on using the concept of “self-efficacy” in place of fear. Self-efficacy refers to an individual’s perceived capability within a specific domain of activities.5
Assessing falls related self-efficacy in performing specific activities or task, rather than global fear of falling, should reveal the extent to which a person believes to participate in specific activities without falling.5
The first such scale to be developed was falls efficacy scale (FES), which measures confidence in performing a range of activities of daily living without falling. But, the original FES has lack of direct relationship between fear of falling and self efficacy or confidence in performing activities without falling and lack of more demanding outdoor activities which may be the concern among higher functioning older people. Thus, in view of improving original FES a measure of fear of falling in a number of respects, Falls Efficacy Scale– International (FES – I) was developed.8
Several studies have used scales to measure fear of falling in elderly. The most commonly used scale based on the frequency with which they appear in the literature, are the Berg Balance Scale(BBS)9, the ‘get up and go test’(GUG)10, the performance oriented assessment of balance (POAB)11, the functional reach test(FR)12, and the falls efficacy scale (FES)13.14,15
The widely used balance performance test to assess balance in elderly people is Berg Balance Scale. The BBS has 14 items (1 sitting and 13 standing items) which are based on 5-level scores, ranging from 0-56. Cut off score of BBS is 45/56.The BBS has high inter-rater (ICC=0.88-0.99) and intra-rater reliability (ICC=0.68-0.99) and construct validity correlations between BBS and the Barthel Index were excellent (r=0.80 to 0.94), and correlations between the BBS and the Fugal Mayer-balance (FM-B) ranged from adequate to excellent (r=0.62 to 0.94).15, 16
The FES –I is a 16 item questionnaire, including the 10 original items from the FES (with some rewording where necessary) and six new items and assesses level of concern about falling when carrying out each activity on a four point scale (1= not at all concerned, 4= very concerned). Both, the internal reliability and test-retest reliability of FES – I were 0.96.One of the recommendations given by the authors of FES – I is to carry out a study to examine the correlations of FES –I scores with other objective measures of balance.8
So, this study is intended to determine the concurrent validity of FES – I with BBS in elderly population.
6.2  Review of Literature:
1)  Hauer K et al. (2009) conducted a study to validate the self-report and interview version of the Falls Efficacy Scale (FES) and the Falls Efficacy Scale International Version (FES-I) in frail geriatric patients with and without cognitive impairment and they concluded that Both scales FES as well as the FES-I showed good to excellent measurement properties in persons with and without moderate cognitive impairment especially in persons with cognitive impairment.17
2)  Eva Nordell et al. (2009) conducted a study to evaluate internal reliability of the FES-I(S) (the Swedish version of the FES-I), and to examine the correlation between fear of falling and health-related quality of life measured with Short Form 12 (SF-12) and they concluded that internal reliability of FES-I as good as any other of measures of fear of falling (Cronbach’s alpha=0.95) which is similar to results in the initial validation of FES-I and there was significant correlation between fear of falling and health related quality of life.18
3)  Lisa Blum et al. (2008) conducted a systematic review of the psychometric properties (including different types of validities and reliabilities) of the BBS specific to stroke at 14, 30, 90 and 180 days of post stroke and suggested that BBS has strong reliability, validity and responsiveness to change, and the test is useful and easy to administer without the need for expensive equipment or prolonged assessment time. Moreover, as BBS has floor and ceiling effects clinician should consider the use of other balance measures in conjunction with the BBS.16
4)  Felicity Anne Langley et al. (2007) conducted a systematic review to identify the concurrent validity, reliability and clinical practicality of functional balance tests with community-dwelling older adults (age-65yrs or above) and reported that BBS is a reliable and valid test for functional balance for older community dwelling adults and thus, it is often used as a gold standard tool to validate other functional balance measures15.
5)  Prof. Gertrudis et al. (2007) carried out a cross-cultural validation of the Falls Efficacy Scale International (FES-I) and they concluded that the FES-I has been shown to have acceptable reliability and construct validity in different samples in different countries and may be used in cross-cultural rehabilitation research and clinical trials.19
6)  Lucy Yardley et al. (2005) developed and validated the Falls Efficacy Scale-International and the results of their study showed that the FES-I has close continuity with the best existing measure of fear of falling with excellent psychometric properties, and also assesses concerns relating to basic and more demanding activities, both physical and social.8
7)  Kim Delbaere et al. (2004) conducted a prospective community based cohort study on fear-related avoidance of activities, falls and physical frailty and concluded that fear-related avoidance of activities may have negative effects on physical abilities and may also be predictive for future falls. Avoidance of activities is therefore an important additional psychological variable in the development of physical frailty and falling in community-living elderly.20
8)  Lucy Yardley et al. (2002) did a prospective study to identify the most common beliefs concerning the negative consequences of falling and determine whether these motivate avoidance of activity among 224 community-living older people (older than 75 years) and found that commonly feared consequences of falling were loss of functional independence and damage to social identity and may motivate avoidance of activity.21
9)  Michel Vassallo et al. (2003) conducted a study on characteristics of early and late fallers on elderly patient rehabilitation wards and concluded that the initial week of patients’ rehabilitation is associated with the greatest risk of falling and early fallers can be predicted by easily identifiable characteristics. This highlights the need for early fall risk assessment.22
10)  Robert G. Coming et al. (2000) done a prospective study to assess the impact of fear of falling on activities of daily living, SF-36 scores, and nursing home admission in 528 older people and concluded that fear of falling has serious consequences for older people viz., deteriorating quality of life, impaired function and loss of independence.23
6.3 Objective of the study
To determine the concurrent validity of Falls Efficacy Scale –International with Berg Balance Scale in elderly population.
6.4 Hypothesis of the study
Hypothesis is not applicable for this study.
Material and Methods:
7.1 Source of data:
Subjects will be taken from societies and the old age homes of Mangalore (Karnataka) and Ahmadabad (Gujarat).
7.2 Method of collection of data:
Sample size:75
Sampling: Purposive Sampling.
Measurement Procedure :
A written consent form (approved by the institution) will be obtained from subjects for voluntary participation in the study. Subjects will be taken based on the selection criteria. Subjects will be explained about the whole procedure and if needed task will be demonstrated. A general geriatric assessment will be taken for the participants including Mini- Mental State Examination (MMSE).
The Berg Balance Scale includes 14 functional activities performed in a standard order. The tasks range from relatively simple to quite complex. Each task is scored on a five point ordinal scale (0 to 4). The subject receives points on a skill for the quality of the performance, the time taken to complete the skill, and/or the time the subject can maintain a specified posture. The maximum score for the Berg Balance Scale is 56.
Falls Efficacy Scale-International (FES-I) is an instrument to measure fear of falling based on the operational definition of this fear as “low perceived self efficacy at avoiding falls during essential, non-hazardous activities of daily living.” It is a 16-item questionnaire, either self-administered or administered through interview that asks respondents to rate their level of confidence in performing common activities.
Each item is rated on a 4-point scale, with 1 indicating “not concerned” and 4 indicating “very concerned”.
Where,
1-no concerned.
2-somewhat concerned.
3-fairly concerned.
4-very concerned.
Materials to be used:
1.  Berg Balance Scale
2.  Falls Efficacy Scale-International
3.  Geriatric Assessment Form
4.  Mini-Mental Status Examination
5.  Paper and pen
6.  Ruler
7.  Chair
8.  Stop watch
Inclusion Criteria
1)  Elderly people between the age of 60 and 80 years living
independently in the community (i.e., independent in self care activities such as eating, dressing, bathing, getting in and out of bed, using the toilet).
2)  Both the genders will be included.
3)  Subjects should able to ambulate independently with or without assistive device.
4)  Mini-Mental State Examination score>23.
Exclusion Criteria
1)  Musculoskeletal problems such as amputation.
2)  Any neurological disorders
3)  Subjects with unstable high blood pressure or heart disease.
Statistical analysis
Study design: Cross-sectional observation study.
Statistical test: Spearman’s Correlation Coefficient.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
YES.
This study evaluates the balance and fear of falling by using the measures, BBS and FES-I in elderly population.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES.
Ethical clearance has been obtained from the Institution’s Ethical Committee.
List of references:
1.  Paola S. Timiras. Physiological basis of aging and geriatrics 2002:CrcPrILlc publisher.
2.  Anne Shumway-Cook, Marjorie H. Woollacott. motor control-Theory and Practical Application 2001:page no.222-247.
3.  Bette R. Bonder, Marilyn B. Wagner. Functional Performance In Older Adults 1994:page no.226
4.  Thomas T. Yoshikawa, Elizabeth L. Cobs, Kenneth Brummel-Smith, Practical Ambulatory Geriatrics 1998; page no.262.
5.  Suraj Kumar,G. Venu Vadhan, Dr. Sachin Awasthi. Madhusudhan Tiwari, Prof. VP. Sharma. Relationship between falling, balance impairment and functional mobility in community dwelling people. IJMPR 2008 octomber: Vol 19:No.2:48-52.
6.  Jong-im-Won. Risk factors of falls among elderly people living in the Rural community.PTK Vol.13 No.4:2006:16-22.
7.  Diana L. Kornetti, Stacy L. Fritz, Yi-Po Chiu, Kathye E. Light And Craig A. Velozo. Rating scale analysis of the Berg Balance Scale. Arch Phys Med Rehabil july 2004:Vol 85: 1128-1135.
8.  Lucy Yardley, Nina Beyer,Klaus Hauer, Gertudis Kempen, Chantal Piot-Ziegler, Chris Todd. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age and Ageing 2005:Vol 34: 614–619.
9.  Berg Katherine, Sharon Wood-Dauphinee, J.I Williams & David Gayton (1989). Measuring balance in the elderly: Preliminary development of an instrument. Physiotherapy Canada 1989:Vol 41:No.6: 304-310.
10. Mathias S, Nayak US, Isaacs B. Balance in elderly patients: the “get-up and go" test. Arch Phys Med Rehabil. 1986 Jun: 67:No.6:387-9.
11. Mary E, Tinetti, T. Franklin Williams And Raymond Mayewski. (1986). Falls risk index for elderly patients based on number of chronic disabilities. American Journal of Medicine: Vol 80: 429-434.
12. Pamela W. Duncan, Debra K. Weiner, Julie Chandler and Stephanie Studenski. Functional Reach: A New Clinical Measure of Balance. Journal of Gerontology 1990:
Vol 45:No.6:M192-M197;
13. Tinetti, Marry E., Donaa R. & Lynda Powell. Falls efficacy as a measure of fear of falling. Journal of Gerontology: Psychological Sciences 1990: Vol 45:No.6:239-243.
14. Dayle Mari Nakamura, Margo B. Holm and Ann Wilson. Measure of balance and fear of falling in elderly. A review, Physical and Occupational Therapy in Geriatrics 1998:
Vol 15:NO.4:17-32
15. Felicity Anne Langley, Shylie.F.H. Mackintosh. Functional balance assessment of older community dwelling adults:a systematic review of the literature. Journal of allied health sciences and practice 2007: Vol 5:No.4:1-11.
16. Lisa Blum, Nicol Korner-Bitensky. Usefulness of BBS in stroke rehabilitation: A systematic review. Physical Therapy: May 2008: Vol 88:No.5:559-566.
17. Hauer K, Yardley L, Beyer N, Kempen G, Dias N, Campbell M, Becker C, Todd C. Validation of the Falls Efficacy Scale and Falls Efficacy Scale International in Geriatric Patients with and without Cognitive Impairment: Results of Self-Report and Interview-Based Questionnaires. Gerontology 2009 Sep 2.[Epub ahead of print]
18. Eva Nordell, Monica Andreasson, Karin Gall and Karl-Goran Thorngren. Evaluating the Swedish version of the Falls Efficacy Scale-International (FES-I). Advances in Physiotherapy 2009:V0l 11:No. 2:81 — 87.
19. Prof. Gertrudis I. J. M. Kempen‌, Chris J. Todd‌, Jolanda C. M. Van Haastregt‌, G. A. Rixt Zijlstra‌, Nina Beyer‌, Ellen Freiberger‌, Klaus A. Hauer‌, Chantal Piot-Ziegler‌ and Lucy Yardley,‌ Cross-cultural validation of the Falls Efficacy Scale International (FES-I) in older people. Results from Germany, the Netherlands and the UK were satisfactory. disability and rehabilitation 2007: VOL 29:No 2:155-162.
20. Kim Delbaere, Geert Crombez, Guy Vanderstraeten, Tine Willems, Dirk Cambier. Fear-related avoidance of activities, falls and physical frailty. A prospective community-based cohort study:age and ageing 2004:Page 1- 6.
21. Lucy Yardley and Helen Smith. A prospective study of the relationship between feared consequences of falling and avoidance of activity in community-living older people. The Gerontological Society of America 2002: Vol 42:No 1:17–23.
22. Michael Vassallo et al, characteristics of early fallers on elderly patient rehabilitation wards. age and ageing 2003:Vol 32: 338-342.
23. Robert G. Cumming et al, Prospective study of the impact of fear of falling on activities of daily living sf-36 scores, and nursing home admission. journal of gerontology, medical science 2000: Vol.55: No.5, M299-M305.
9 /
Signature of the Candidate
/
10 /
Remarks of the Guide
/
11 /

Name & Designation of:

11.1 Guide
11.2 Signature / DR.S.BALASUBRAMANIAN
Associate Professor in Physiotherapy
11.3 Co-Guide (If Any)
11.4 Signature / DR.PRIYANKA SINGH
Assistant Professor in Physiotherapy
11.5 Head of the Department

11.6 Signature

/
DR. T.JOSELEY SUNDERRAJ PANDIAN

Associate Professor in Physiotherapy and P.G Coordinator