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

NCT04529200 | Unknown

• 1 other identifier: 1502-PHD-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Injury; Fall Patients; Geriatric Fall; Physical Therapy; Balance Traiing

Keywords

geriatric; fall; balance training

Outcome Measures

Primary Outcomes (7)

• Elderly mobility scale

  questionaire used to evaluate condition of elders

  8 week

• Timed Up and go test (TUG)

  questionaire used to evaluate mobility

  8 week

• Berg Balance Test

  questionaire used to evaluate balance

  8 week

• Activities of Balance Confidence

  questionaire used to evaluate balance

  8 week

• Fullerton Advanced Balance (FAB) Scale

  questionaire used to evaluate function of balance in older adult

  8 week

• 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

• Dynamic gait index

  The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.

  8 week

Study Arms (2)

1. Comprehensive fall prevention protocol group (CARE)

EXPERIMENTAL

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

Other: electrotherapy treatment

2. Conventional balance training group

ACTIVE COMPARATOR

conventional protocol commonly used for rehabilitation

Other: electrotherapy treatment

Interventions

electrotherapy treatment OTHER

physical therapy management like EMS IFT

1. Comprehensive fall prevention protocol group (CARE); 2. Conventional balance training group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Musculoskeletal conditions (fractures, severe arthritis)
• Neurological conditions like Epilepsy, Parkinson,
• Alzheimer's, Impaired cognition
• Other systemic diseases or co-morbidities

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Isra University

Islamabad, Capital, 44000, Pakistan

RECRUITING

Central Study Contacts

Imran Rafique, Ph.D

CONTACT

+923006460439; drimranppdpt@gmail.com

Usman Janjua, Ph.D

CONTACT

+923214109550; usmanjanjua84@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded randomization as assessor and patient both were unaware
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Imran Rafiq

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: January 5, 2019
• Primary Completion: November 10, 2020
• Study Completion: December 30, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

PA (1)