Cognitive Impairment Clinical Trial
— 5iTUGOfficial title:
Protocol for the Method Study: Evaluation of the Measurement Properties of an Instrumented and Repeated Timed Up and Go (5iTUG)
Verified date | September 2019 |
Source | Robert Bosch Gesellschaft für Medizinische Forschung mbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | September 16, 2019 |
Est. primary completion date | September 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
Inclusion Criteria: - community-dwelling - aged between 60 and 80 years - are able to walk 30m independently Exclusion Criteria: - any severe cardiovascular, pulmonary, neurological, or mental diseases. |
Country | Name | City | State |
---|---|---|---|
Germany | Robert-Bosch-Hospital | Stuttgart | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Robert Bosch Gesellschaft für Medizinische Forschung mbH | Norwegian University of Science and Technology |
Germany,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | five time Sit to Stand (5xSTS) | needed time for 5 time repeated sit to stand | Baseline | |
Secondary | 30 seconds Chair Stand (30s CS) | 30 seconds chair stand number of repetitions | Baseline | |
Secondary | Gait speed | Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch | Baseline | |
Secondary | Community Balance and Mobility Scale (CBMS) | Community Balance and Mobility Scale, Score range from 0-96 points (with 96 is the best performance), duration: 35 minutes | Baseline | |
Secondary | 8-level balance score | 8-level balance score, each balance position held for 15 seconds, test stopped when position can not be completed, scored out of 8, higher points indicate better performance | Baseline | |
Secondary | Short Physical Performance Battery (SPPB) | Short Physical Performance Battery total and sub-scores, 3 balance tests each balance position held for 10 seconds, test stopped when position can not be completed, habitual gait speed over 4m, 5 time sit to stand, higher points indicate better performance, score range 0-12, duration: 8 minutes | Baseline | |
Secondary | Late Life Function and Disability questionnaire for Function (LLFDI) | Late Life Function and Disability (LLFDI) questionnaire, subjective measurement of functional ability and disability, scale range 0-100 points, higher points indicate better performance | Baseline |
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