NCT02705690

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

March 7, 2016

Last Update Submit

March 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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)

    Baseline

Interventions

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)

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince Charles Hospital

Gurnos Rd, Merthyr Tydfil, CF47 9DT, United Kingdom

Location

Prince Charles Hospital

Cardiff, CF47 9DT, United Kingdom

Location

MeSH Terms

Conditions

Ankle InjuriesKnee InjuriesSpinal Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesBack Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations