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

March 9, 2016 updated by: Stannah Stairlifts
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cardiff, United Kingdom, CF47 9DT
    • Merthyr Tydfil
      • Gurnos Rd, Merthyr Tydfil, United Kingdom, CF47 9DT
        • Prince Charles Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Stannah_Balance_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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