NCT03528395

Brief Summary

Stroke creats dependancy of patients due to various associated impairments. The use of low-cost technologies for neurological rehabilitation may be beneficial for the treatment of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2017

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

Study Start

First participant enrolled

May 20, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed
Last Updated

March 25, 2019

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

May 5, 2018

Last Update Submit

March 21, 2019

Conditions

Stroke

Keywords

BalanceBaropodometryVideo gamesVirtual reality

Outcome Measures

Primary Outcomes (1)

  • Timed get up and go

    It is a test used to evaluate functional mobility and balance, adapted and translated into Spanish. The patient must get up from a chair, walk three meters in a straight line, turn and return to sit in the chair. The valuation is quantified from 1 to 5: 1- normal, and 5- fall hazard during the test. At present study was conducted supervised by two people that were placed laterally to the patient.

    eight weeks

Secondary Outcomes (8)

  • Tinetti scale

    eight weeks

  • Baropodometry

    eight weeks

  • Static Posturography

    eight weeks

  • Functional reach test

    eight weeks

  • Modified Rankin scale

    eight weeks

  • +3 more secondary outcomes

Study Arms (2)

Semi-immersive virtual reality

EXPERIMENTAL

8 week protocol with semi-immersive virtual reality provided with the XBOX 360º video game console and its Kinect device. The commercial video games used will be: Kinect Sports I ®, Kinect Sport II ®, Kinect Joy Ride ® and Kinect Adventures ®.

Other: Semi-immersive virtual reality

Conventional Rehabilitation

ACTIVE COMPARATOR

Physical therapy and Occupational Therapy based on a task-oriented approach

Other: Conventional Rehabilitation

Interventions

Semi-immersive virtual realityOTHER

Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.

Also known as: Commercial video games
Semi-immersive virtual reality
Conventional RehabilitationOTHER

Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.

Also known as: Physical therapy and Occupational Therapy
Conventional Rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with CVA in subacute ischemic or hemorrhagic type.
  • NIHSS scale score less than 20.
  • MoCA test with scores equal to or greater than 14 (mild cognitive impairment or absence of cognitive impairment).
  • Modified Rankin scale between 0-4.
  • Patients with the ability to maintain autonomous sitting and standing with or without aids.
  • Patients who have received the information document of the study and signed the informed consent form.

You may not qualify if:

  • NIHSS scale scores greater than 21 .
  • MoCA test with score lower than 14.
  • Modified Rankin scale between 5-6.
  • Patients without the ability to maintain autonomous sitting.
  • Patients who refused to sign the informed consent form.
  • Hospital discharge expected at the beginning of the study.
  • Patients who at any time have shown worsening of the general state, disinterest or desire to leave the study.
  • Pathologies susceptible to worsening or contraindication with virtual reality devices and commercial video games:
  • Photosensitive epilepsy.
  • Modified Ashworth scale greater than 2.
  • Moderate-severe cognitive impairment.
  • Visual alterations.
  • Non-collaborating patient.
  • Behavioral alterations.
  • Refusal to treatment with VR systems.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Fuenfría

Cercedilla, Madrid, 28479, Spain

Location

Related Publications (2)

  • Cano-Manas MJ, Collado-Vazquez S, Cano-de-la-Cuerda R. [Commercial video games in the rehabilitation of patients with sub-acute stroke: a pilot study]. Rev Neurol. 2017 Oct 16;65(8):337-347. Spanish.

    PMID: 28990643RESULT

  • Cano-Manas MJ, Collado-Vazquez S, Rodriguez Hernandez J, Munoz Villena AJ, Cano-de-la-Cuerda R. Effects of Video-Game Based Therapy on Balance, Postural Control, Functionality, and Quality of Life of Patients with Subacute Stroke: A Randomized Controlled Trial. J Healthc Eng. 2020 Feb 13;2020:5480315. doi: 10.1155/2020/5480315. eCollection 2020.

    PMID: 32148744DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy ModalitiesOccupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • MªJosé Cano Mañas, PhD program

    Hospital La Fuenfría

    PRINCIPAL INVESTIGATOR

  • Roberto Cano de la Cuerda, PhD

    Universidad Rey Juan Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
All assessments will be made by blind evaluators with respect to the established study groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly distributed to a control group or experimental group using the QuickCalcs application of GraphPad Software. The following considerations will be taken into account: Control group: 8 weeks of conventional rehabilitation based on a task-oriented approach. Consisting of five weekly sessions of physical therapy and of occupational therapy, lasting 45 minutes each. Experimental group: 8 weeks of conventional rehabilitation provided identically as in the control group, plus virtual reality semi-immersive sessions. VR sessions will be applied following a protocol using commercial video games, three days a week (Monday, Wednesday and Friday) after the conventional rehabilitation sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2018

First Posted

May 17, 2018

Study Start

May 20, 2017

Primary Completion

November 20, 2018

Study Completion

March 7, 2019

Last Updated

March 25, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)