NCT02960165

Brief Summary

Objective: Evaluate whether a task practiced in virtual environment could provide better performance than the same task in real environment and if performing a task in virtual environment could enable transfer to the same task in real environment and vice versa. Method: the investigators evaluated 65 older adults of both genders, aged 60-82 years. The investigators applied a timing coincident task to measure the perceptual-motor ability to perform a motor response. The participants were divided into two groups: a) started in a real interface and b) started in a virtual interface.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

November 2, 2016

Last Update Submit

November 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement and transfer of performance through virtual and real task, by using motor learning protocol (acquisition phase, retention and transfer tests) - with one outcome: motor learning.

    1 week

Study Arms (4)

Virtual interface group A

EXPERIMENTAL

Older adults that started the practice on the virtual interface

Behavioral: Virtual interface group

Virtual interface group B

EXPERIMENTAL

Older adults that started the practice on the virtual interface and then practiced on real task.

Behavioral: Virtual interface group

Real interface group A

ACTIVE COMPARATOR

Older adults that started the practice on the virtual interface

Behavioral: Real interface group

Real interface group B

ACTIVE COMPARATOR

Older adults that started the practice on the real interface and then practiced on virtual task.

Behavioral: Real interface group

Interventions

First practice on virtual interface in order to evaluate the improvement and its influence on real interface performance (second practice).

Virtual interface group AVirtual interface group B

First practice on real interface in order to evaluate the improvement and its influence on virtual interface performance (second practice).

Real interface group AReal interface group B

Eligibility Criteria

Age60 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy cognitive and motor conditions to understand and perform the required activity

You may not qualify if:

  • less than 23 points on a Mini Mental State Examination administered before testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Arts, Sciences and Humanities of the University of Sao Paulo

São Paulo, São Paulo, 03828000, Brazil

Location

Study Officials

  • Carlos BM Monteiro, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 9, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations