NCT02165163

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 cancer patients. The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in cancer patients 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 Sep 2013

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

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

June 13, 2014

Last Update Submit

May 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postural Balance

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

    after 4 weeks

Secondary Outcomes (1)

  • Gait performance

    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

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 VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ability to ambulate without assistance
  • willingness to provide informed consent
  • cancer
  • neuropathy related to chemotherapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bijan Najafi, PhD

    interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations