Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG)

NCT03769220 | Completed

• 1 other identifier: 850/2018BO1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In order to tailor interventions, objective assessments of physical function is needed. A limitation of several of today's clinical assessments is that they require too much time and/or space. The Timed Up and Go (TUG) is a commonly used clinical test of physical function in older populations. The TUG is particularly useful due to its short administration time and the little space that is required. The TUG is however of limited value when used in higher-functioning older adults due to ceiling effects. Instrumented versions of TUG (iTUG) computes several outcome measures in addition to the traditional outcome measure which is the total duration. The aim of this study is to evaluate the construct- and discriminative validity of outcomes derived from sensor signals recorded with a smartphone during a five times repeated iTUG (5iTUG).

Conditions

Measurement Properties of 5iTUG; Physical Disability; Balance; Cognitive Impairment; Leg Strength; Gait Disorder, Sensorimotor; Activity of Daily Living

Keywords

Time up and Go Test

Outcome Measures

Primary Outcomes (1)

• five time repeated instrumented time up and Go Test (5iTUG)

  Discriminative ability of the 5iTUG compared to other clinical measurements (include acceleration, velocity, duration of movements, number of steps, and step variability, from the different sub-phases of the TUG test, such as sit-to-walk, walk, first/last turn, and walk-to-sit). By performing five repetitions of an instrumented TUG (5iTUG), it is possible to get features that are more sensitive from the instrument, in addition to in total five repetitions of sit-to-stand, turning, and turn-to-sit movements, along with a total of 30 meters of walking. The 5iTUG quantifies the movement characteristics from tasks that resembles those carried out in other independent clinical measurements and test batteries, such as the Five times sit-to-stand, gait assessments, and 30s chair stand. Variability repetitions within the trials will be analysed using a repeated measures analysis.

  Baseline

Secondary Outcomes (7)

• five time Sit to Stand (5xSTS)

  Baseline

• 30 seconds Chair Stand (30s CS)

  Baseline

• Gait speed

  Baseline

• Community Balance and Mobility Scale (CBMS)

  Baseline

• 8-level balance score

  Baseline

Study Arms (3)

inpatient rehabilitation ward

The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital (RBK). The treating medical doctor will inform potentially eligible participants about the possibility of being involved in this study. Should participants confirm their interest a research assistant will complete a detailed information session and obtain written informed consent prior enrolment. Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

outpatient rehabilitation clinic

Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital (RBK). The treating doctor will again inform the potential participant about the study and invite them to participate. A research assistant will complete a detailed information session and written informed consent will be obtained prior enrolment. Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

community dwelling older adults

Lastly 20 community dwelling older adults will be invited to participate. Recruitment will occur through advertisement at a locally run seniors fitness group, conducted every Thursday at RBK. Older adults who are interested in being involved will be invited to receive additional information about the study and the involved procedures before providing written informed consent and being enrolled. Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital. Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital. Lastly 20 community dwelling older adults will be invited to participate.

You may qualify if:

• community-dwelling
• aged between 60 and 80 years
• are able to walk 30m independently

You may not qualify if:

• any severe cardiovascular, pulmonary, neurological, or mental diseases.

Sponsors & Collaborators

• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Robert-Bosch-Hospital

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Related Publications (4)

• Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. doi: 10.1046/j.1532-5415.2003.51104.x.

  PMID: 12588574 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.

  PMID: 23350947 BACKGROUND

• Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012 May;36(1):163-5. doi: 10.1016/j.gaitpost.2012.02.006. Epub 2012 Mar 14.

  PMID: 22421189 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate/PhD Candidate

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: December 10, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)