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

Primary Purpose

Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Ankle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
iOS Balance Application
Sponsored by
Stannah Stairlifts
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arthroplasty, Replacement, Hip

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Prince Charles Hospital
  • Prince Charles Hospital

Outcomes

Primary Outcome Measures

Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score

Secondary Outcome Measures

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.

Full Information

First Posted
March 7, 2016
Last Updated
March 9, 2016
Sponsor
Stannah Stairlifts
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02705690
Brief Title
Benchmarking the iOS Balance Application Against the Berg Balance Test
Acronym
BBAaBBT
Official Title
Benchmarking the iOS Balance Application Against the Berg Balance Test
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stannah Stairlifts
Collaborators
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Ankle Injuries, Knee Injuries, Accidental Falls, Spinal Injuries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
iOS Balance Application
Intervention Description
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 Measure Information:
Title
Spearman's Rank Coefficient to compare the Root Mean Square from iOS application to the Berg Balance Scale Score
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shruti Grover, MSc
Phone
07767118256
Email
shruti.grover@stannah.co.uk
Facility Information:
Facility Name
Prince Charles Hospital
City
Gurnos Rd
State/Province
Merthyr Tydfil
ZIP/Postal Code
CF47 9DT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aled Falvey, Extended scope physiotherapist
Phone
07775561415
Email
Aled.Falvey@wales.nhs.uk
Facility Name
Prince Charles Hospital
City
Cardiff
ZIP/Postal Code
CF47 9DT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aled Falvey, PgDip
Phone
07775561415
Email
Aled.Falvey@wales.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

Benchmarking the iOS Balance Application Against the Berg Balance Test

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