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

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ClinicalTrials.gov Identifier: NCT04529200
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
imran rafiq, Isra University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Fall Injury Fall Patients Geriatric Fall Physical Therapy Balance Traiing Other: electrotherapy treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description: double blinded randomization as assessor and patient both were unaware
Primary Purpose: Treatment
Official Title: Effects of Comprehensive Fall Prevention Protocol (CARE: Cognitive-Aerobic-Resistance-Exer-gaming) on Mobility Level in Elderly
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Elderly mobility scale [ Time Frame: 8 week ]
    questionaire used to evaluate condition of elders

  2. Timed Up and go test (TUG) [ Time Frame: 8 week ]
    questionaire used to evaluate mobility

  3. Berg Balance Test [ Time Frame: 8 week ]
    questionaire used to evaluate balance

  4. Activities of Balance Confidence [ Time Frame: 8 week ]
    questionaire used to evaluate balance

  5. Fullerton Advanced Balance (FAB) Scale [ Time Frame: 8 week ]
    questionaire used to evaluate function of balance in older adult

  6. 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.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529200


Contacts
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Contact: Imran Rafique, Ph.D +923006460439 drimranppdpt@gmail.com
Contact: Usman Janjua, Ph.D +923214109550 usmanjanjua84@hotmail.com

Locations
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Pakistan
Isra University Recruiting
Islamabad, Capital, Pakistan, 44000
Contact: imran rafiq, PHD*    +923006460439    drimranppdpt@gmail.com   
Contact: usman janjua, PHD*    +923214109550    usmanjanjua84@hotmail.com   
Sponsors and Collaborators
Isra University
More Information
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Responsible Party: imran rafiq, Dr Imran Rafiq, Isra University
ClinicalTrials.gov Identifier: NCT04529200    
Other Study ID Numbers: 1502-PHD-004
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by imran rafiq, Isra University:
geriatric
fall
balance training