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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04529200
Other study ID # 1502-PHD-004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 5, 2019
Est. completion date December 30, 2020

Study information

Verified date August 2020
Source Isra University
Contact Imran Rafique, Ph.D
Phone +923006460439
Email drimranppdpt@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2020
Est. primary completion date November 10, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
electrotherapy treatment
physical therapy management like EMS IFT

Locations

Country Name City State
Pakistan Isra University Islamabad Capital

Sponsors (1)

Lead Sponsor Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elderly mobility scale questionaire used to evaluate condition of elders 8 week
Primary Timed Up and go test (TUG) questionaire used to evaluate mobility 8 week
Primary Berg Balance Test questionaire used to evaluate balance 8 week
Primary Activities of Balance Confidence questionaire used to evaluate balance 8 week
Primary Fullerton Advanced Balance (FAB) Scale questionaire used to evaluate function of balance in older adult 8 week
Primary Functional reach test 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
Primary Dynamic gait index The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk. 8 week
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