Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Benchmarking the iOS Balance Application Against the Berg Balance Test (BBAaBBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02705690
Recruitment Status : Unknown
Verified March 2016 by Stannah Stairlifts.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Stannah Stairlifts

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Ankle Injuries Knee Injuries Accidental Falls Spinal Injuries Device: iOS Balance Application Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Benchmarking the iOS Balance Application Against the Berg Balance Test
Study Start Date : May 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Intervention Details:
  • Device: iOS Balance Application

    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)



Primary Outcome Measures :
  1. Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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) [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705690


Contacts
Layout table for location contacts
Contact: Shruti Grover, MSc 07767118256 shruti.grover@stannah.co.uk

Locations
Layout table for location information
United Kingdom
Prince Charles Hospital Not yet recruiting
Gurnos Rd, Merthyr Tydfil, United Kingdom, CF47 9DT
Contact: Aled Falvey, Extended scope physiotherapist    07775561415    Aled.Falvey@wales.nhs.uk   
Prince Charles Hospital Not yet recruiting
Cardiff, United Kingdom, CF47 9DT
Contact: Aled Falvey, PgDip    07775561415    Aled.Falvey@wales.nhs.uk   
Sponsors and Collaborators
Stannah Stairlifts
University College, London

Study Data/Documents: Analytic Code  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Stannah Stairlifts
ClinicalTrials.gov Identifier: NCT02705690     History of Changes
Other Study ID Numbers: Stannah_Balance_01
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Knee Injuries
Ankle Injuries
Spinal Injuries
Leg Injuries
Back Injuries