NCT06481384

Brief Summary

Digital health is an effective solution to overcome logistical and access challenges in urban and rural areas. Telephysiotherapy can play a vital role in tracking and monitoring health and risk factors in older adults.The aim of this study was to determinate the validity and the reliability of the self-administered Timed Up and Go (TUG) test, a gold standard test for fall risk screening, when compared to the traditional face-to-face assessment carried out by a physiotherapist. The protocol included sociodemographic and history of falls questions, the Self-Efficacy for Exercise questionnaire, the Activities and Participation Profile Related to Mobility (PAPM) and three functional tests, namely the 10-Meter Walking Speed (10-MWS) test, TUG test and 30 Seconds Sit to Stand (30s STS) test. Within an interval of 18-24 hours after the face-to-face moment, the participants were invited and instructed to self-administer the TUG test at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 24, 2024

Last Update Submit

June 27, 2024

Conditions

Keywords

TelephysiotherapySelf-administeredTimed Up and Go testReliabilityValidity

Outcome Measures

Primary Outcomes (2)

  • Time Up and Go Test face-to-face

    Seconds

    Day 0

  • Time Up and Go test self-administered

    Seconds

    18-24 hours after the first measurement

Secondary Outcomes (9)

  • Fear of falling

    Day 0

  • History of falls

    Day 0

  • Sedentary behaviours

    Day 0

  • Education Level

    Day 0

  • Health self-perception

    Day 0

  • +4 more secondary outcomes

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants were adults aged 50 or over, living in the community, who took part in fall risk screening actions advertised in the usual places (municipalities and associations) in the centre of Portugal.

You may qualify if:

  • Female and male individuals, aged 50 years or over;
  • Residents in the community;
  • Present the ability to carry out screenings;
  • The individual cannot know the result of the test carried out in person;
  • The individual must agree to take the home test;
  • Sign to participate in the study and sign the informed consent form.

You may not qualify if:

  • Age less than 50 years old;
  • Residing in an institution;
  • Not being able or unwilling to give informed consent prior to completing the questionnaire;
  • People who demonstrate difficulties in understanding the indications for carrying out functional tests, raising doubts about their cognitive capacity/dementia/ and/or depression;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Tecnologia da Saúde de Coimbra

Coimbra, 3046-854, Portugal

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigador

Study Record Dates

First Submitted

June 24, 2024

First Posted

July 1, 2024

Study Start

October 10, 2023

Primary Completion

May 25, 2024

Study Completion

May 25, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations