NCT02214342

Brief Summary

The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment. The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.

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 Jul 2014

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

2 months

First QC Date

August 8, 2014

Last Update Submit

December 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postural Balance

    Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)

    4 weeks

Secondary Outcomes (5)

  • Gait performance

    4 weeks

  • Cognitive status

    4 weeks

  • Fear of falling

    4 weeks

  • User experience

    4 weeks

  • Depressive signs

    4 weeks

Study Arms (2)

Balance Training

EXPERIMENTAL

Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.

Other: Balance Training

Control

NO INTERVENTION

The control group will keep their normal activity without receiving any intervention.

Interventions

Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.

Balance Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Mild Cognitive Impairment
  • willingness to provide informed consent

You may not qualify if:

  • severe neurologic, cardiovascular, metabolic, or psychiatric disorders
  • severe visual impairment
  • severe cognitive impairment
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

MeSH Terms

Conditions

Neurologic ManifestationsCognition Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Bijan Najafi, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 12, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations