Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000018415
Ethics application status
Approved
Date submitted
1/04/2024
Date registered
13/01/2025
Date last updated
13/01/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is the Sway App a valid and sensitive tool to measure balance in healthy adults?
Scientific title
Is the Sway App for balance a valid and sensitive tool when compared with the gold standard SMART EquiTest System when using foot mobilisation/preparation on balance responses in healthy young adults
Secondary ID [1] 311864 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance impairment 333411 0
Condition category
Condition code
Public Health 332691 332691 0 0
Health service research
Physical Medicine / Rehabilitation 330091 330091 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was mobilisation of each foot for 6 minutes.

The foot mobilisation/preparation technique is based on the Bobath Concept and was performed on both feet by an experienced senior physiotherapist who had previously received formal training in the Bobath Concept.

Participants were seated in a chair with their foot supported by the therapist’s thigh.

The intervention was tailored to each participant’s presentation with a focus on mobilisation of all the joints of the foot and ankle. This included for example, ankle dorsiflexion, plantarflexion, inversion and eversion, gliding movements between the tarsal and metatarsal bones, and toe flexion and extension movements. Further, sensory and proprioceptive input was provided via stretching, massage and release of soft tissue around the lower leg and foot (including calf and foot muscles).

The intervention of foot mobilisation was used to measure validity and sensitivity to change of the Sway App. The Sway App (Sway Medical, Tulsa, OK, USA) is a smartphone application that measures static standing balance using the triaxial accelerometer located in the smart device. As described in the testing protocol below, the Sway App was used by the participant holding the mobile phone uploaded with the Sway App at the front of their chest. The tests used to assess balance were the unilateral stance test (UST) on the left leg (eyes open and eyes closed), and the UST on the right leg (eyes open and eyes closed). These components can be found in the mBESS (modified Balance Error Scoring System) and the CDC 4-stage balanced modules within the App.

The Sway App measured balance responses at the same time as those responses were being measured by the gold standard SMART EquitTest System. The protocol for testing, supervised by a member of the research team, follows.

1. Participants were fitted with the SMART EquiTest harness.
2. Participants were asked to stand barefoot on the SMART EquiTest System and were secured with the harness.
3. At the same time, participants were asked to hold a mobile phone with the Sway App at the front of their chest.
4. Participants were given one familiarisation trial.
5. Participants then completed the UST protocol in which they were asked to perform 3 trials of the UST for 10 seconds in each of the
four following conditions:
a. with eyes-open standing on left leg,
b. with eyes-closed standing on left leg,
c. with eyes-open standing on right leg, and
d. with eyes-closed standing on right leg.
6. During each 10 second period, participants’ balance was measured via both the SMART EquiTest System and the Sway App.
7. Participants then received 6 minutes of foot mobilisation per foot.
8. Immediately post-intervention, participants’ balance was reassessed, and data were collected repeating protocol points 1 to 6.
Intervention code [1] 328322 0
Treatment: Other
Comparator / control treatment
The SMART EquiTest System is the reference comparator.

The SMART EquiTest System (NeuroCom, Oregon, USA) is recognised as the gold standard in measuring balance. This system uses a dynamic force plate which measures movement of the centre of gravity position via the vertical forces exerted through the subject’s feet. A dynamic visual surround can measure the patient’s use of visual information to maintain balance.

The protocol for use of the SMART EquiTest, supervised by a member of the research team, is the same as that used to evaluate the Sway App and is as follows.

1. Participants were fitted with the SMART EquiTest harness.
2. Participants were asked to stand barefoot on the SMART EquiTest System and were secured with the harness.
3. At the same time, participants were asked to hold a mobile phone with the Sway App at the front of their chest.
4. Participants were given one familiarisation trial.
5. Participants then completed the unilateral stance test (UST) protocol in which they were asked to perform 3 trials of the UST
for 10 seconds in each of the
four following conditions:
a. with eyes-open standing on left leg,
b. with eyes-closed standing on left leg,
c. with eyes-open standing on right leg, and
d. with eyes-closed standing on right leg.
6. During each 10 second period, participants’ balance was measured via both the SMART EquiTest System and the Sway App.
7. Participants then received 6 minutes of foot mobilisation per foot.
8. Immediately post-intervention, participants’ balance was reassessed, and data were collected repeating protocol points 1 to 6.
Control group
Active

Outcomes
Primary outcome [1] 337845 0
Sensitivity to change of the Sway App
Timepoint [1] 337845 0
At completion of all assessments.
Primary outcome [2] 337844 0
Validity of the Sway App
Timepoint [2] 337844 0
At completion of all assessments.
Secondary outcome [1] 433447 0
Change in balance after the foot mobilisation intervention
Timepoint [1] 433447 0
Immediately after foot mobilisation intervention

Eligibility
Key inclusion criteria
Healthy adults
Aged from 18 to 40 years
Able to write and speak in English
Able to provide informed consent
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of lower limb injuries within the past year
History of lower back pain that may affect balance
History of dizziness or loss of consciousness within the past year
History of inner ear disorders
History of nervous system disorders
History of unexplained falls
Uncorrected visual conditions
Alcohol intake within 24 hours of testing
Taking medications that may affect balance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pearson's correlation for validity of Sway App
Related Samples Wilcoxon Signed Rank Test for change in balance
Effect size of change for comparison between the Sway App and the SMART EquiTest to determine sensitivity to change

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2022
Date of last participant enrolment
Anticipated
Actual
17/06/2022
Date of last data collection
Anticipated
Actual
17/06/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26347 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 42320 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316206 0
University
Name [1] 316206 0
Curtin University
Country [1] 316206 0
Australia
Primary sponsor type
University
Name
Curtin School of Allied Health
Address
Country
Australia
Secondary sponsor category [1] 318390 0
None
Name [1] 318390 0
Address [1] 318390 0
Country [1] 318390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315024 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 315024 0
Ethics committee country [1] 315024 0
Australia
Date submitted for ethics approval [1] 315024 0
21/10/2021
Approval date [1] 315024 0
16/12/2021
Ethics approval number [1] 315024 0
RGS0000004881

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

Contacts
Principal investigator
Name 133458 0
Dr Robyn Fary
Address 133458 0
Curtin School of Allied Health, Curtin University, Kent Street, Bentley, WA, 6102
Country 133458 0
Australia
Phone 133458 0
+61 8 92663313
Fax 133458 0
Email 133458 0
[email protected]
Contact person for public queries
Name 133459 0
Robyn Fary
Address 133459 0
Curtin School of Allied Health, Curtin University, Kent Street, Bentley, WA, 6102
Country 133459 0
Australia
Phone 133459 0
+61 8 92663313
Fax 133459 0
Email 133459 0
[email protected]
Contact person for scientific queries
Name 133460 0
Robyn Fary
Address 133460 0
Curtin School of Allied Health, Curtin University, Kent Street, Bentley, WA, 6102
Country 133460 0
Australia
Phone 133460 0
+61 8 92663313
Fax 133460 0
Email 133460 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case at the discretion of the primary investigator after a sound reason for requiring information provided.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified Sway App and SMART EquiTest data
De-identified before and after foot mobilisation data

What types of analyses could be done with individual participant data?
• Only to achieve the purpose provided to primary investigator

When can requests for individual participant data be made (start and end dates)?
From:
Available from 04/04/2024 and available for the following 7 years

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Subject to approval from the primary investigator. [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.