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

NCT ID: NCT04529200

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-05

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fall Injury Fall Patients Geriatric Fall Physical Therapy Balance Traiing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Total 40 patients fulfilling the inclusion criteria will be included in this study. Treatment will be given 3 times a week for 24 weeks by researcher with each session lasting for 40 to 45 Minutes. Assessment will then be done at baseline, after 04, 08, 12 and 24 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double blinded randomization as assessor and patient both were unaware

Study Groups

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1. Comprehensive fall prevention protocol group (CARE)

every week protocol change for every patient according to 1 repetition maximum

Group Type EXPERIMENTAL

electrotherapy treatment

Intervention Type OTHER

physical therapy management like EMS IFT

2. Conventional balance training group

conventional protocol commonly used for rehabilitation

Group Type ACTIVE_COMPARATOR

electrotherapy treatment

Intervention Type OTHER

physical therapy management like EMS IFT

Interventions

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electrotherapy treatment

physical therapy management like EMS IFT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isra University

OTHER

Sponsor Role lead

Responsible Party

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imran rafiq

Dr Imran Rafiq

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isra University

Islamabad, Capital, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Rafique, Ph.D

Role: CONTACT

+923006460439

Usman Janjua, Ph.D

Role: CONTACT

+923214109550

Facility Contacts

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imran rafiq, PHD*

Role: primary

+923006460439

usman janjua, PHD*

Role: backup

+923214109550

Other Identifiers

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1502-PHD-004

Identifier Type: -

Identifier Source: org_study_id

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