NCT02696538

Brief Summary

The purpose of this research study is to investigate how useful three balance tests are in predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance Evaluation Systems Test (mini-BESTest).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

March 11, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

February 26, 2016

Last Update Submit

October 10, 2018

Conditions

Traumatic Brain InjuryAcquired Brain InjuryAccidental Falls

Keywords

Fall riskRehabiliationPhysical TherapyFunctional Gait Assessmentmini-Balance Evaluation Systems TestBerg Balance ScalePsychometric propertiesValidityInter-rater reliabilityMontreal Cognitive Assessment

Outcome Measures

Primary Outcomes (5)

  • total score on Functional Gait Assessment

    Baseline

  • total score on Berg Balance Scale

    Baseline

  • total on mini-Balance Evaluation System Test

    Baseline

  • reported fall history

    a fall is defined as unplanned and unexpected contact with the floor or lower surface not due to medical emergency (stroke, seizure, cardiac event) or environmental hazards (chair collapsing, earthquake)

    six month

  • reported fall history

    a fall is defined as unplanned and unexpected contact with the floor or lower surface not due to medical emergency (stroke, seizure, cardiac event) or environmental hazards (chair collapsing, earthquake)

    twelve month

Secondary Outcomes (1)

  • Montreal Cognitive Assessment

    Baseline

Study Arms (1)

Experimental

EXPERIMENTAL

All participants included in this group and will complete all three outcomes assessment

Other: Functional Gait AssessmentOther: mini-Balance Evaluation Systems TestOther: Berg Balance Scale

Interventions

Functional Gait AssessmentOTHER

Balance assessment

Experimental
mini-Balance Evaluation Systems TestOTHER

Balance assessment

Experimental
Berg Balance ScaleOTHER

Balance assessment

Experimental

Eligibility Criteria

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

You may qualify if:

  • community dwelling
  • medically stable
  • able to stand at least one minute unsupported (with/without assistive device)
  • able to ambulate 20 feet (with/without assistance or assistive device)
  • able to follow one step instructions or visual demonstrations.

You may not qualify if:

  • presence of partial or non-weight bearing on a lower extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marissa Lyon

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Marissa F Lyon, DPT

    Memorial Hermann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 2, 2016

Study Start

March 11, 2016

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)