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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02333994
Other study ID # D3456
Secondary ID
Status Completed
Phase N/A
First received January 1, 2015
Last updated January 7, 2015
Start date March 2013
Est. completion date January 2014

Study information

Verified date January 2015
Source Maharishi Markendeswar University
Contact n/a
Is FDA regulated No
Health authority India:Maharishi Markandeshwar UniversityUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.


Description:

Present study was an experimental design. A total of 60 elderly subjects were selected as per the selection criteria and they were randomly allocated in two equal groups i.e.Group A- (Experimental Group)- Balance Exercises and Education Program Group B - (Control Group) - Balance exercises.procedure of study was explained to each subject and written consent was taken from them.

Aim:

The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population .

Materials and Methods In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- Elderly

- Both males and females were included in the study.

- Individuals with Mini Mental Status Examination score >23.

- History of falls in last 6 months

Exclusion Criteria:

- Any musculoskeletal disorder

- Any visual deficit

- Any systemic disease

- Any Neurological Disorder

- Any Cardiovascular and Respiratory Disorder

- Now cooperative Individuals

- Any Psychological disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
GROUP A education programme as well as balance training exercises
Group A received education programme as well as balance training exercises.The intervention group attended one-hour training classes once a week for 6 consecutive weeks. The classes involved both lectures and discussions and were guided through with handouts and worksheets. Each session began by giving a summary of the previous session and continued with the main topic of the session. The intervention program also engaged the participants in discussions about their concerns regarding falling and on topics pertaining to identifying and reducing the risk factors of falls, including environmental hazards in and out of the house
Other:
GROUP B on-platform training
on-platform training was performed while standing and while sitting on a 22-inch therapeutic ball, 1 eyes open or closed 2 normal or reduced area of foot support 3 on foam or floor 4 with or without manual p

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maharishi Markendeswar University

Outcome

Type Measure Description Time frame Safety issue
Primary BERG BALANCE SCALE 6 weeks Yes
Secondary ACTIVITY BALANCE CONFIDENCE SCALE 6 WEEKS Yes
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