Effects of Comprehensive Fall Prevention Protocol (CARE: Cognitive-Aerobic-Resistance-Exer-gaming) on Mobility Level in Elderly

August 24, 2020 updated by: imran rafiq, Isra University
Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.

Cost effective treatment for patients. To meet the expectation of patient to improve their quality of life and improvement of their satisfactory level. It will be interesting for patient to visualize the activity patient is performing and comparison of effectiveness of comprehensive fall prevention protocol with traditional balance training.

It will reduce the occurrence of fall episodes and hence reduce the cost to treat these fall and fall related injuries. Older adult will be less dependent, and more mobile and contributing member of the community.

Objectives

The objectives of the study are:

  1. To compare the effect of comprehensive fall prevention protocol (CARE) on fall risk as compared to conventional training in elderly.
  2. To compare the effect of comprehensive fall prevention protocol (CARE) on Mobility Level as compared to conventional training in elderly.
  3. To compare the effect of comprehensive fall prevention protocol (CARE) on Wii Fit balance as compared to conventional training in elderly.
  4. To compare the effect of comprehensive fall prevention protocol (CARE) on Dynamic Balance as compared to conventional training in elderly.
  5. To compare the effect of comprehensive fall prevention protocol (CARE) on Quality of life as compared to conventional training in elderly.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals of age 60 -80 years
  • Either gender
  • Berg balance score between 20-40

Exclusion Criteria:

  • • Musculoskeletal conditions (fractures, severe arthritis)

    • Neurological conditions like Epilepsy, Parkinson,
    • Alzheimer's, Impaired cognition
    • Other systemic diseases or co-morbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1. Comprehensive fall prevention protocol group (CARE)
every week protocol change for every patient according to 1 repetition maximum
Other: electrotherapy treatment
physical therapy management like EMS IFT
ACTIVE_COMPARATOR: 2. Conventional balance training group
conventional protocol commonly used for rehabilitation
Other: electrotherapy treatment
physical therapy management like EMS IFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elderly mobility scale
Time Frame: 8 week
questionaire used to evaluate condition of elders
8 week
Timed Up and go test (TUG)
Time Frame: 8 week
questionaire used to evaluate mobility
8 week
Berg Balance Test
Time Frame: 8 week
questionaire used to evaluate balance
8 week
Activities of Balance Confidence
Time Frame: 8 week
questionaire used to evaluate balance
8 week
Fullerton Advanced Balance (FAB) Scale
Time Frame: 8 week
questionaire used to evaluate function of balance in older adult
8 week
Functional reach test
Time Frame: 8 week
This test measures the distance between the length of an outstretched arm in a maximal forward reach from a standing position,while maintaining a fixed base of support.
8 week
Dynamic gait index
Time Frame: 8 week
The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isra University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 5, 2019

Primary Completion (ANTICIPATED)

November 10, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (ACTUAL)

August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1502-PHD-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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