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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Physical Therapy

Clinical Trials on electrotherapy treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings