NCT02475083

Brief Summary

The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable stroke

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

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
Last Updated

June 18, 2015

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

June 12, 2015

Last Update Submit

June 15, 2015

Conditions

Stroke

Keywords

StrokeVirtual realityBalanceFalls

Outcome Measures

Primary Outcomes (1)

  • Dynamic Gait Index (DGI)

    Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.

    avarage 8 weeks

Secondary Outcomes (1)

  • Number of Falls

    avarage 8 weeks

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Rehabilitation with virtual reality using games with balance training goal.

Other: Virtual RealityOther: Conventional

Conventional Group

ACTIVE COMPARATOR

Conventional physiotherapy with exercises for balance training.

Other: Conventional

Interventions

Virtual RealityOTHER

Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.

Virtual Reality Group
ConventionalOTHER

Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.

Conventional GroupVirtual Reality Group

Eligibility Criteria

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

You may qualify if:

  • patients of both sexes with hemiparesis after stroke of 18 to 65 years.

You may not qualify if:

  • less than 6 months of injury with sensory or perceptual deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Erika Fonseca

    Pedreira, Érika, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 18, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 18, 2015

Record last verified: 2014-08