Arthroplasty, Replacement, HipBBAaBBTNCT02705690
Benchmarking the iOS Balance Application Against the Berg Balance Test
A study testing iOS Balance Application in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Stannah Stairlifts at 2 sites in United Kingdom.
Trial summary
This study aims to benchmark the performance of an iOS application against the Berg Balance Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring balance across the continuum from acute care to community-based care. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Ankle Injuries
- What is being tested?
- iOS Balance Application
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 - 69 Selected to undergo a Berg Balance Sale Impairments including : Ankle injures, Knee Replacements, Hip Replacements, Knee injuries, ligament tears etc.
Who cannot join
- Subjects will be excluded from participation if they have peripheral neuropathy (clinically diagnosed or if they had symptoms of numbness/tingling in the lower extremities); pain of any level presenting simultaneously in both lower extremities; or unilateral lower extremity pain >3 on the 11 point visual analog (box) scale. Pregnant women will be excluded.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Prince Charles Hospital
Cardiff, CF47 9DT
Aled Falvey, PgDip, 07775561415, Aled.Falvey@wales.nhs.uk
Prince Charles Hospital
Gurnos Rd, Merthyr Tydfil, CF47 9DT
Aled Falvey, Extended scope physiotherapist, 07775561415, Aled.Falvey@wales.nhs.uk
About this study
This study aims to benchmark the performance of an iOS application against the Berg Balance Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring balance across the continuum from acute care to community-based care. An iPhone will be tied around the waist of the participant and concurrent measurements will be taken for five of the fourteen stances which comprise the BBS.
Read the detailed description
'Project Balance' aims to make balance an actionable component of an individuals health, allowing a long term intervention via a monitoring and training of balance health much before a fall happens. Towards this end, we have designed an iOS application and a belt. The phone is kept stable against the lower back of the participant using the belt. The application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis. These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support)
Studies in the past have compared the use of accelerometers to the use of the clinical measured of Timed Up (TUG) test and Berg Balance Scale (BBS) in the assessment of postural stability and indicated that there is a high correlation between BBS, TUG and Accelerometry. Accelerometry has also found to be able to distinguish between sway responses to differing balancing conditions and between fallers and non-fallers.
We aim to conduct a benchmarking study for our iOS application against the BBS.
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Ankle Injuries, Knee Injuries, Accidental Falls, Spinal Injuries
- Being tested
- iOS Balance Application
- Medical subject headings
- Ankle Injuries, Knee Injuries, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iOS Balance ApplicationDevice
We have designed an iOS application and a belt. The application uses accelerometer data to calculate postural sway. Steps:
The phone is kept stable against the lower back of the participant using the belt.
The iOS application gives instructions to user to adopt the correct stance (eg: Standing Unsupported, legs side by side) Once the stance is adopted, the application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis.
These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support)
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score
Measured: Baseline
Secondary outcomes (1)
Symmetry Ratio (Root Mean Square Left Leg vs Root Mean Square Right Leg) AP/ML Ratio (Ratio of the Anterior Posterior movement vs the media lateral movement)
The iOS application can compare the Root Mean Square(RMS) from the left leg to the right leg to produce a symmetry ratio for the physiotherapist, this provides a more granular view of the participants balance health. Similarly, the application can calculate the ratio of Anterior Posterior movement to the Media Lateral movement.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stannah Stairlifts
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705690
- Sponsor's protocol ID
- Stannah_Balance_01
- Acronym
- BBAaBBT
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarking the iOS Balance Application Against the Berg Balance Test
- ClinicalTrials.gov ID
- NCT02705690
- Acronym / sponsor ID
- BBAaBBT / Stannah_Balance_01
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Ankle Injuries, Knee Injuries, Accidental Falls, Spinal Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stannah StairliftsIndustry (pharma, biotech, devices)
- Collaborators
- University College, London
- Study start
- May 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to benchmark the performance of an iOS application against the Berg Balance Scale (BBS), which is the most commonly used assessment tool by clinicians for measuring balance across the continuum from acute care to community-based care. An iPhone will be tied around the waist of the participant and concurrent measurements will be taken for five of the fourteen stances which comprise the BBS.
Detailed description
'Project Balance' aims to make balance an actionable component of an individuals health, allowing a long term intervention via a monitoring and training of balance health much before a fall happens. Towards this end, we have designed an iOS application and a belt. The phone is kept stable against the lower back of the participant using the belt. The application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis. These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support)
Studies in the past have compared the use of accelerometers to the use of the clinical measured of Timed Up (TUG) test and Berg Balance Scale (BBS) in the assessment of postural stability and indicated that there is a high correlation between BBS, TUG and Accelerometry. Accelerometry has also found to be able to distinguish between sway responses to differing balancing conditions and between fallers and non-fallers.
We aim to conduct a benchmarking study for our iOS application against the BBS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between the ages of 18 - 69 Selected to undergo a Berg Balance Sale Impairments including : Ankle injures, Knee Replacements, Hip Replacements, Knee injuries, ligament tears etc.
Key exclusion criteria (1 listed)
- Subjects will be excluded from participation if they have peripheral neuropathy (clinically diagnosed or if they had symptoms of numbness/tingling in the lower extremities); pain of any level presenting simultaneously in both lower extremities; or unilateral lower extremity pain >3 on the 11 point visual analog (box) scale. Pregnant women will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iOS Balance ApplicationWe have designed an iOS application and a belt. The application uses accelerometer data to calculate postural sway. Steps: The phone is kept stable against the lower back of the participant using the belt. The iOS application gives instructions to user to adopt the correct stance (eg: Standing Unsupported, legs side by side) Once the stance is adopted, the application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis. These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support) | Device | – |
Primary outcome
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score
Time frame: Baseline
1 secondary outcome
Symmetry Ratio (Root Mean Square Left Leg vs Root Mean Square Right Leg) AP/ML Ratio (Ratio of the Anterior Posterior movement vs the media lateral movement)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iOS Balance Application in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Stannah Stairlifts at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shruti Grover, MSc (07767118256, shruti.grover@stannah.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.