FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over

Accidental Falls Clinical Trial

Official title:

FallSensing Clinical Tool for Fall Risk Prevention in Community-dwelling Adults Aged 50 Years or Over

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591185
• Other study ID #: 1
• Secondary ID: POCI-01-0247-FED
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2018
• Source: Escola Superior de Tecnologia da Saúde de Coimbra
• Contact: Anabela C Martins, PhD
• Phone: +351917973625
• Email: anabelacmartins[@]estescoimbra.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%.

Several studies recognize the benefits of the Otago Exercise Program (OEP) on physical functioning and falls reduction in older people. The program includes strength and balance exercises with a difficulty level progression by increasing weights and number of repetitions, in association with a walking plan.

FallSensing clinical tool includes a software, a pressure platform and two inertial sensors. The software includes a range of exercises based on Otago Exercise Program, including warming, balance and strength exercises. The software allows that healthcare professional prescribes a tailored exercise program according to the individual needs. During exercise performance, pressure distribution can be analysed by the healthcare professional, providing real time feedback to the individual.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• adults aged 50 years or over;

• Community-dweller

• independent to be standing and walking, with or without walking aids,

• interest to participate in the study.

Exclusion Criteria:

• individuals with severe sensorial impairments (deafness or blindness)

• individuals with cognitive impairments which precludes the ability to comprehend the questionnaire, functional tests and exercises included in the protocol.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• FallSensing Clinical Tool
FallSensing clinical tool will be applied to a group of community-dwelling adults aged 50 years or over, including a initial evaluation, 24 intervention sessions (2 or 3 sessions per week) and a final evaluation. Inicial and final evaluation consists in six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test "modified" and 10 meters Walking Speed) and a questionnaire concerning self-efficacy for exercise.

Locations

Country	Name	City	State
Portugal	Physio Mondego	Coimbra

Sponsors (3)

Lead Sponsor	Collaborator
Anabela Correia Martins	Fraunhofer Portugal AICOS, Sensing Future Technologies

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go	seconds	Change from baseline time to perform TUG up to 12 weeks
Primary	Self-efficacy for Exercise	Score 5 to 20 points	Change from baseline Self-efficacy for exercise score up to 12 weeks
Secondary	Grip Strength	Kilogram-force	Outset and up to 12 weeks
Secondary	30 seconds Sit-to-Stand	number of stands	Outset and up to 12 weeks
Secondary	Step Test	number of steps	Outset and up to 12 weeks
Secondary	4 Stage Balance Test "Modified"	last position accomplished	Outset and up to 12 weeks
Secondary	10 meters Walking Speed	meters per second	Outset and up to 12 weeks