Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000726550
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
13/06/2024
Date last updated
13/06/2024
Date data sharing statement initially provided
13/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Spanish linguistic validation, validity and reliability testing of Frail´BESTest in institutionalized frail people older than 60 years old with mild cognitive impairment
Scientific title
Spanish linguistic validation, validity and reliability testing of Frail´BESTest in institutionalized frail people older than 60 years old with mild cognitive impairment
Secondary ID [1] 310722 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 331664 0
mild cognitive impairment 331667 0
Condition category
Condition code
Public Health 328390 328390 0 0
Health service research
Neurological 328391 328391 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
AIM:
The primary purpose of this study is to validate linguistically the Frail Best test and then to identify the reliability and validity of this instrument that detects static and dynamic balance problems in institutionalized older fragile people with mild cognitive impairment.
TASKS:
Frail'BESTest it is an assessment tool validated that aims to identify disorder systems underlying postural control responsible for poor functional balance in Frail individuals. It has 26 items, 23 test that evaluate performance of 6 balance systems: A: anticipations, B: reactions, C: locomotion, D: sensorial orientation, E: biomechanical constraints and F: asymmetric gait. Each one of these sub-systems include different test or criteria are included. All test or criteria are scored dichotomously assigning 0 for negative results or 1 for positive. The maximum and best possible score for Frail'BESTest it is 26 and minimum 0.

A. Proactive motor control anticipatory maximum score is 5 and minimum 0 (represents 19% of the Frail’BESTtest score).
B. Reactive motor control - reactions- maximum score is 2 and minimum 0 (represents 8% of the Frail’BEST test score).
C. Locomotion and gait maximum score is 6 and minimum 0 (represents 23% of the Frail’BESTtest score).
D. Static postural control maximum score is 3 and minimum 0 (represents 12% of the Frail’BESTtest score).
E. Biomechanical restrictions maximum score is 6 and minimum 0 (represents 23% of the Frail’BESTtest score).
F. Gait symmetry maximum score is 4 and minimum 0 (represents 15% of the Frail’BESTtest score),

EQUIPMENT:
Minimum equipment is require 1) foam (mean density 55 kg/m3) for the “sensorial orientation” section 2) a 15-cm-high rehabilitation step for the “anticipations” section. 3) Stopwatch, 4) Instruction tools (paper or tablet), 5) Ruler, 6) Chair with armrests

TEST SUPERVISION/CONDUCTION
Motor assessments are immediately score by the physiotherapist or exercise physiologist that are supervising and conducting the test.

TIME NEEDED TO COMPLETE THE TEST
Frail’BESTest is feasible. Based on previous publications an experienced testers, 10 minutes are necessary to complete the test in frail participants.

This Cross-sectional study consists of five phases.

PHASE 1 [Ph1] [T0] Consist on the linguistic validation and it will be carried out the transcultural adaptation of Frail'BESTest in a population sample (named group A), which will be make up of 30 individuals over 60 years of age, community living independently in their houses, cognition preserve (scoring > or = to 27 with Mini Mental State Examination, MMSE), who have a preserve physical functional status (score less than 2 or equal to 2 on Fried Phenotype), and able to stand up still, without assistive devices for 10s or over (Group A).
A Physical therapist or exercise Physiologists will give instruction to participants. They will be ask if they understand the instructions and it will be confirm with the execution of the test whether they perform as plann and safe. It is anticipate being conduct over 4 weeks period. Week one begins with first participant at Ph1,


PHASE 2 [Ph2] [T0 and T1] consist on reliability. Starts 1 weeks after the end of Ph1.
Two subgroups (Group B and Group C) of institutionalized frail aged participants (scoring 3 or more in FRIED TEST), n=30 with mild cognitive impairment (scoring 24-26 at MMSE) (named Group B) and 30 without mild cognitive impairment (scoring = or >27 at MMSE) (named group C) will be test.
We will examine between raters reliability and test-retest reliability.
To examine reliability between testers, at baseliene Test (T0) two different physiotherapist will be testing at the same time.
To examine test-retest reliability, the first 30 participants from group B, called Group B1 will be test at baseline (T0) and on a second occasion during the 7 days following baseline test (T1). Participants will maintain usual activities of geriatric institution or nursing home these days. Week one begins with first participant at Ph1., Ph2 length it is arround 7 weeks. ans Phase 2 it is anticipate being conduct over an accumulative time of 12 weeks. That is Ph1 4wks+1wk +Ph2 7wks)


PHASE 3 [Ph3] [T0] consisting on construct validity. Ph3 starts together Ph1 for Group A. and together Ph2 for Group B and Group C.
The three subsamples are:
1) non-institutionalized people over 60 years old, cognitively intact and highly functioning (Group A) n=30,
2) Institutionalized elderly with mild cognitive impairment and frailty (Group B) n= 210
3) Cognitively intact and fragile institutionalized older people (Group C). n= 30

Each participant will be test at baseline only once (T0). Week one begins with first participant at Ph1. Ph3 length it is arround 22 weeks. Testing the whole sample (270 participants) It is anticipate being conduct over an accumulative time of 34 weeks. (That is Ph1 4wks+1wk +Ph2 7wks+ Ph3 22wks)

PHASE 4 [Ph4] [T3] consisting on predictive falls/concurrent validity. Will take part participants from Group B and Group C, Ph4 starts the day after Ph3.
Week one begins with first participant at Ph1. Ph4 length it is arround 26 weeks .P4 it is anticipate being conduct over an accumulative time of 60 weeks. (That is Ph1 4wks+1wk +Ph2 7wks+ Ph3 22wks +Ph4 26wks).
Each participant from Group B and Group C will take part and after baselinte test day (T0) they will be follow up for 6 months (T3) for outcomes related with falls and their consequences. During P4 articipants will maintain usual activities of the geriatric institution or nursing home.

PHASE 5 [Ph5] [T4] consisting on predictive deaths/concurrent validity. Will take part participants from Group B and Group C,
Week one begins with first participant at Ph1. Ph5 length it is arround 26 weeks .P5 it is anticipate being conduct over an accumulative time of 86 weeks. (That is Ph1 4ws+1w +Ph2 7ws+ Ph3 22ws +Ph4 26ws+ Ph426ws). Ph5 starts the day after baseline test (Ph2 or Ph3) and together Ph4, for 12 months (T4).
It is anticipate being conduct over an accumulative time of 86 weeks. Week one begins with first participant at Ph1.Each participant from Group B and Group C will take part and after baseline test day he/she will be follow up for 12 months, (T4) or until death. During the follow up time time or until the outcome, each participants will maintain usual activities of the geriatric institution or nursing home.


Detailed information about FrailBESTest administration and testing procedure has been obtained from Kubicki A, and Kubicki A, Brika M, Coquisart L, Basile G, Laroche D, Mourey F. The Frail'BESTest. An Adaptation of the "Balance Evaluation System Test" for Frail Older Adults. Description, Internal Consistency and Inter-Rater Reliability. Clin Interv Aging. 2020 Jul 30;15:1249-1262. doi: 10.2147/CIA.S247332. PMID: 32801673; PMCID: PMC7398746.
Kubicki A, Laroche D, Coquisart L, Basile G, Brika M, Mourey F. The Frail'BESTest: an adaptation of the "balance evaluation system test" for frail older adults; Concurrent validity, responsiveness, validity for fall prediction and detection of slower walkers. Eur Rev Aging Phys Act. 2021 Oct 28;18(1):22. doi: 10.1186/s11556-021-00276-8. PMID: 34711173; PMCID: PMC8555199.

A. Kubicki, F. Mourey, Rehabilitación geriátrica: enfoque sistémico, Volume , Issue, /2016, Pages , ISSN 1293-2965, http://dx.doi.org/10.1016/S1293-2965(15)76057-3 (http://www.sciencedirect.com/science/article/pii/S1293-2965(15)76057-3).
Intervention code [1] 327128 0
Diagnosis / Prognosis
Comparator / control treatment
Reliability
Test-retest reliability is calculated using the baseline test (T0) and the same physiotherapist repeats the baseline test 7 days after the baseline test (T1).
The inter-rater reliability of the Frail'BESTest will be compared to that of the existing reference standard tests MiniBESTest, POMA, SPPB, dual task cost of naming on gait speed, dual task cost of gait on naming and dual task cost of counting backwards on Timed up and Go.
The prospective validity of the Frail'BESTest, MiniBESTest, POMA, SPPB, dual task cost of naming on gait speed, dual task cost of gait on naming, and dual task cost of counting backwards on Timed Up and Go will be evaluated. The occurrence of adverse events, such as falls and deaths, will be monitored over a period of six months (T4) and one year (T5) following the baseline assessment (T2a). All tests require standard equipment and minimal training to administer. The motor assessment is immediately scored by the physiotherapist or exercise physiologist supervising and conducting the test.

1. The MiniBESTest is designed to assess the complementary systems that contribute to balance function. Its objective is to identify six different balance control systems, with the aim of enabling the design of specific rehabilitation approaches for different balance deficits. The entire test takes 10-15 minutes to complete.

2. Performance Oriented Mobility Assessment (T0) (T1)
This assesses a person's perception of balance and stability during activities of daily living. It has two sections: Section 1 assesses balance, comprising nine items. Section 2 assesses dynamic balance during walking, comprising seven items. The total score is 16 for balance and 12 for gait; the POMA score is 28. The entire test takes 7-10 minutes to complete.

3. The Short Physical Performance Battery (SPPB) is a test that has been used as a predictor of potential disability and may be useful in monitoring lower limb function in older people. It combines scores for 4 m walking speed, 5 consecutive chair stands and balance. Scores range from 0 (worst) to 12 (best), with each test ranging from 0 to 4 (Guralnik et al., 2000). The entire test takes 10-15 minutes.
4. 10m Walking Speed (GS) (T0) (T1)

4. A gait speed test assesses an individual's functional mobility. Gait speed is calculated as the time taken to walk 10 m on level ground at a comfortable (normal/natural) speed over the entire distance. Two attempts are made, and the maximum speed is used for further analysis. Individual gait speed is calculated using the formula 10 m divided by the time taken to walk 10 m. The whole test takes 3-5 minutes.

5. 10-meter dual-task gait speed (DT-GS) (T0) (T1)
This represents the functional mobility of the individual performing two tasks simultaneously (walking and naming cities) over a 10-meter test distance. No instructions are provided regarding the prioritisation of tasks. The time taken to complete the test is recorded the in the dual-task walking speed is calculated. The entire test takes approximately one to two minutes.

6. The dual task cost of naming on gait speed (DTC-GS) (T0) (T1) is defined as the percentage change in speed between single-task and dual-task conditions. The formula for calculating this is as follows: the difference between the single task gait speed and the dual task gait speed value, all these divided by the single task gait speed and multiplied per 100.

7. Naming frequency (N)
represents the number of towns from the area that the participant is able to name correctly and without repetition in 30 seconds. The calculation is performed using the formula 30 divided by the number of towns. The procedure takes approximately one minute.

8. Dual-task naming (DTN) (T0) (T1)
assesses an individual's cognitive ability to perform two tasks simultaneously. Values are obtained concurrently with DT-GS, and the number of cities named correctly and without repetition is also recorded. The DT-N score is calculated using the following formula: the time taken to walk 10 m is divided by the number of cities that are correctly named without repetition.

9. Dual task cost of gait on naming (DTC-N) (T0) (T1)
This is the percentage change in naming frequency between the single task of naming and the dual task (walking and naming) using the formula: the difference between naming frequency-N- and by dual task naming DTN divided by naming frequency and multiplied per 100

10. Falls (T2)
The number of falls, and consequences associated to falls will be obtain from medical history records of nursing homes.
11. Deaths (T3)
Deaths and time to Participant’s death will be obtained from medical history records of nursing homes

Three different subgroups will be test for the purpose of the study

Group A: Community Living, Non-Frail individuals Cognition preserved (n=30)
Baseline (T1) 1) Frail BESTest 2)The Mini Balance Evaluation System (MiniBESTest) 3) Performance Oriented Mobility Assessment (POMA) 4) Short physical performance Battery (SPPB) 5) Dual task Cost of naming on Gait Speed 6) Dual task cost of gait on naming 7) Dual task cost counting backwards on Timed up and Go 9) Timed up and go

Group B: Institutionalized Frail with mild cognitive impairment n=240 (divided in two groups, n= 30 and n=210)
Group B1: n=30
Baseline (T0) and 7 days (T1) following baseline :1) Frail BESTest 2) The Mini MiniBESTest 3) POMA 4) SPPB) 5) Dual task Cost of naming on Gait Speed 6) Dual task cost of gait on naming 7) Dual task cost counting backwards on Timed up and Go, 8) Falls for 6 months (T2) following baseline test day, 9) Deceases. 1 year (T2) following baseline test day

Group B2: n=210
Baseline (T0): 1) Frail BESTest, 2) POMA, 3) SPPB 4) Dual task Cost of naming on Gait Speed 5) Dual task cost of gait on naming 6) Dual task cost counting backwards on Timed up and Go.
7) Falls for 6 months (T2) following baseline test day, 8) Deceases. 1 year (T2) following baseline test day

Group C: Institutionalized Frail without cognitive impairment. n=40
Baseline (T0) and 7 days (T1) following baseline :1) Frail BESTest 2) The Mini MiniBESTest 3) POMA 4) SPPB) 5) Dual task Cost of naming on Gait Speed 6) Dual task cost of gait on naming 7) Dual task cost counting backwards on Timed up and Go, 8) Falls for 6 months (T2) following baseline test day, 9) Deceases. 1 year (T2) following baseline test day
Control group
Active

Outcomes
Primary outcome [1] 336224 0
Frail’BESTest; assesses static, dynamic balance and mobility. It is a composite primary outcome
Timepoint [1] 336224 0
Baseline (T0) and 7 days (T1) following baseline.
Primary outcome [2] 336225 0
The short Physical performance Battery assesses functional performance
Timepoint [2] 336225 0
Baseline (T0) and 7 days (T1) following baseline.
Primary outcome [3] 336226 0
Timed up and go assess lower limb function
Timepoint [3] 336226 0
Baseline (T0) and 7 days (T1) following baseline.
Secondary outcome [1] 427434 0
Dual task cost of naming on gait speed assesses the ability of executing two tasks (naming and walking) in this case the effect of cognitive task on gait speed.
Timepoint [1] 427434 0
Baseline (T0) and 7 days (T1) following baseline
Secondary outcome [2] 432058 0
Dual task cost of gait on naming is the ability executing two tasks (naming and walking) and the effect gait activity on naming task.
Timepoint [2] 432058 0
Baseline (T0) and 7 days (T1) following baseline
Secondary outcome [3] 432061 0
The composite secondary outcome Mini Balance Evaluation System (MiniBESTest) is employed to assess systems that contribute to balance function using static, dynamic balance test and mobility test
Timepoint [3] 432061 0
Baseline (T0) and 7 days (T1) following baseline
Secondary outcome [4] 432062 0
The composite secondary outcome Performance Oriented Mobility Assessment (POMA) is also known as Tinetti test. It assesses balance and mobility
Timepoint [4] 432062 0
Baseline (T0) and 7 days (T1) following baseline
Secondary outcome [5] 432063 0
Falls
Timepoint [5] 432063 0
6 months (T2) Following baseline Test
Secondary outcome [6] 432064 0
Patient’s deaths
Timepoint [6] 432064 0
1 year (T3) following baseline
Secondary outcome [7] 432185 0
Dual task cost of counting backwards on Timed up and Go assesses the ability of executing two tasks (counting backwards and performing a mobility test) on the mobility task.
Timepoint [7] 432185 0
Baseline (T0) and 7 days (T1) following baseline

Eligibility
Key inclusion criteria
Participants should be able to maintain 10seconds stand feet apart without assistance
The Validity of FRAILBESTest in mild cognitive impairment institutionalized patients will be made of subgroup categories: Frail/Non-frail; Cognition preserved/Mild cognitive impairment patients and Institutionalized patients/community living individuals.

Frailty will be determine by Fried phenotype Those scoring 3 or more out of 5 will be classify as frail and those scoring 2 or less as non-frail individuals. Mini-Mental State Examination (MMSE) cognition status could be preserved or altered (Score >24-30).

Community living individuals will be non-frail and cognition should preserved they will be assign to Group A.
Frail institutionalized individual’s (scoring from 24 to 26 at MMSE) will be assign to Group B
Frail institutionalized individual’s (scoring = or > to 27 at MMSE) will be assign to Group C
Minimum age
60 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Orthopedic unstable conditions
- Moderate or severe cognitive status Score <24 at MMSE
- Inability to understand indications or communicate with testers.
- Sustaining severe cardiac, vascular or respiratory diseases or conditions that contraindicate physical activity
- Presenting a condition for which, in the opinion of the researchers, the evaluation may pose a risk to their health
- Not having autonomy to decide about their voluntary participation in the study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Continuous variables will be presented with the mean and standard deviation (SD), percentages will be used for dichotomous, categorical and ordinal variables. 95% confidence interval (CI).
The reliability of Frail'BESTest and each of the underlying systems of postural control of balance will be examine in each group with the intraclass correlation coefficient (ICC) between evaluators and the intrarater ICC, with a 95% confidence interval (CI) using variance analysis models. An ICC is define as: (1) very good or excellent > 0.75; (2) good, 0.74 to 0.60; (3) fair, from 0.59 to 0.40; and (4) poor, < 0.4.

This analysis will be carried out for subsample B (30 subjects with frailty and mild cognitive impairment-R and subsample C (30 subjects with frailty and without cognitive impairment.
The evaluation of internal consistency will be carry out using Cronbach's Alpha. Values greater than 0.70 will be establish to indicate the internal consistency of the scales.
The Pearson correlation coefficient will be calculated to examine the validity of the criteria, comparing the relationship between the Frail ´BESTest, SPPS and the Timed Up and Go, Gait speed, POMA and MiniBESTest Test. A correlation (r value) between 0 and 0.25 will be interpreted as:
(1) little or no relationship, between 0.25 and 0.5; as
(2) a poor ratio, between 0.5 and 0.75; as
(3) moderate; and
(4) above 0.75 as a very good to excellent ratio.

The presence of floor and ceiling effects is define as 15% or more of participants with the lowest or highest possible score on the Frail'BESTest.
Criterion validity will examine the correlation between the score obtained in the Frail ´BEST and the SPPB or between the Frail ´BESTest and the Timed Up and Go Test, Frail ´BESTest and Gait speed, Frail ´BESTest and POMA, Frail ´BESTest and MiniBESTest globally and with each of the test indicators.

Construct validity will be analyzed with the Student T test or Mann-Witney U test, comparing the differences in the global result in Frail'BESTest for the sample of people who are classified as mild cognitive impairment frail, with low and moderate functionality. This same analysis will be use with each of the frailty phenotype indicators.

Prospective validity of Frail ´BESTest, SPPS, the Timed Up and Go, Timed up and go dual task Gait speed, Gait speed dual task, POMA and all variables of Dual task cost will be calculate for falls prediction and deaths.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment outside Australia
Country [1] 25850 0
Spain
State/province [1] 25850 0
Aragón/Zaragoza
Country [2] 25905 0
Spain
State/province [2] 25905 0
Basque Country/Biskay

Funding & Sponsors
Funding source category [1] 314947 0
University
Name [1] 314947 0
Universidad de Zaragoza
Country [1] 314947 0
Spain
Funding source category [2] 315044 0
University
Name [2] 315044 0
Basque Country University
Country [2] 315044 0
Spain
Funding source category [3] 315045 0
Other
Name [3] 315045 0
Casa Amparo (Zaragoza City Council)
Country [3] 315045 0
Spain
Funding source category [4] 315046 0
Charities/Societies/Foundations
Name [4] 315046 0
Residential Care Fundation Ozanam
Country [4] 315046 0
Spain
Funding source category [5] 315047 0
Charities/Societies/Foundations
Name [5] 315047 0
Rey Ardid Fundation
Country [5] 315047 0
Spain
Primary sponsor type
University
Name
Universidad de Zaragoza
Address
C/ Domingo Miral s/n, 50009 - Zaragoza
Country
Spain
Secondary sponsor category [1] 317069 0
University
Name [1] 317069 0
Basque Country University
Address [1] 317069 0
Campus de Leioa Barrio Sarriena, s/n 48940 Leioa (Bizkaia)
Country [1] 317069 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313929 0
Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (CEICA)
Ethics committee address [1] 313929 0
Ethics committee country [1] 313929 0
Spain
Date submitted for ethics approval [1] 313929 0
08/09/2023
Approval date [1] 313929 0
18/10/2023
Ethics approval number [1] 313929 0
PI23/430

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129826 0
Dr Maria del Pilar Dominguez Olivan
Address 129826 0
Universidad de Zaragoza C/Domingo Miral, s/n 50009 Zaragoza
Country 129826 0
Spain
Phone 129826 0
+34 876554461
Fax 129826 0
Email 129826 0
[email protected]
Contact person for public queries
Name 129827 0
Maria del Pilar Dominguez Olivan
Address 129827 0
Universidad de Zaragoza C/Domingo Miral, s/n 50009 Zaragoza
Country 129827 0
Spain
Phone 129827 0
+34 876554461
Fax 129827 0
Email 129827 0
[email protected]
Contact person for scientific queries
Name 129828 0
Mirian Aranzazu Garrues Irisarri
Address 129828 0
Campus de Leioa Barrio Sarriena, s/n 48940 Leioa (Bizkaia)
Country 129828 0
Spain
Phone 129828 0
+34 946013312
Fax 129828 0
Email 129828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not decided yet


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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