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

NCT03591185 | Unknown

• 2 other identifiers: 1POCI-01-0247-FEDER-003464
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Accidental Falls

Keywords

Accidental Falls; Primary prevention; Pressure platform; Inertial Sensor

Outcome Measures

Primary Outcomes (2)

• Timed Up and Go

  seconds

  Change from baseline time to perform TUG up to 12 weeks

• Self-efficacy for Exercise

  Score 5 to 20 points

  Change from baseline Self-efficacy for exercise score up to 12 weeks

Secondary Outcomes (5)

• Grip Strength

  Outset and up to 12 weeks

• 30 seconds Sit-to-Stand

  Outset and up to 12 weeks

• Step Test

  Outset and up to 12 weeks

• 4 Stage Balance Test "Modified"

  Outset and up to 12 weeks

• 10 meters Walking Speed

  Outset and up to 12 weeks

Study Arms (1)

Exercise group

EXPERIMENTAL

Exercise group, including community-dwelling adults aged 50 years or over, will perform an initial evaluation, 24 intervention sessions with FallSensing clinical tool (2 or 3 sessions per week) and a final evaluation.

Other: FallSensing Clinical Tool

Interventions

FallSensing Clinical Tool OTHER

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.

Exercise group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anabela Correia Martins: lead
• Sensing Future Technologies: collaborator
• Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions: collaborator

Study Sites (1)

Physio Mondego

Coimbra, 3000-098, Portugal

RECRUITING

Central Study Contacts

Anabela C Martins, PhD

CONTACT

+351917973625; anabelacmartins@estescoimbra.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer Physiotherapy Dept.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 19, 2018
• Study Start: July 10, 2017
• Primary Completion: September 30, 2018
• Study Completion: October 31, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-06

Locations

PT (1)