- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02705690
Benchmarking the iOS Balance Application Against the Berg Balance Test (BBAaBBT)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shruti Grover, MSc
- Phone Number: 07767118256
- Email: shruti.grover@stannah.co.uk
Study Locations
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-
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Cardiff, United Kingdom, CF47 9DT
- Prince Charles Hospital
-
Contact:
- Aled Falvey, PgDip
- Phone Number: 07775561415
- Email: Aled.Falvey@wales.nhs.uk
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Merthyr Tydfil
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Gurnos Rd, Merthyr Tydfil, United Kingdom, CF47 9DT
- Prince Charles Hospital
-
Contact:
- Aled Falvey, Extended scope physiotherapist
- Phone Number: 07775561415
- Email: Aled.Falvey@wales.nhs.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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