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StrokeNCT03528395

Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation

A study testing Semi-immersive virtual reality and Conventional Rehabilitation in people with Stroke, run by Hospital La Fuenfría at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Semi-immersive virtual reality and Conventional Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSpain
Study dates
20 May 2017to 7 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Presence of other neurological pathologies.
  • Other cardiovascular diseases that contraindicate physical exercise.
  • Visual or auditory, musculoskeletal, bone or joint alterations in acute or chronic phase that could influence the primary pathology.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital La Fuenfría

    Cercedilla, Madrid, 28479

Other trials in Spain

About this study

Official title: Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation: Randomized Clinical Trial

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.

Read the detailed description

To determine the effectiveness of a structured protocol using semi-immersive virtual reality with commercial videogames for balance, postural control, functional independence, quality of life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in subacute phase and are being treated in a mid-stay hospital.

Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive conventional therapy (physical therapy and occupational therapy) intervention being based on a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational Therapy with duration of 45 minutes per session.

The experimental group will receive in addition to the above an experimental intervention during 8 weeks providing additional treatment using virtual reality semi-immersive complement is added by means of commercial video games implemented with the Xbox 360º video game console in conjunction with the Kinect device.

Conditions
Stroke
Being tested
Semi-immersive virtual reality, Conventional Rehabilitation
Keywords
Balance, Baropodometry, Video games, Virtual reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-immersive virtual realityOther

    Also called Commercial video games

    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.

  • Conventional RehabilitationOther

    Also called Physical therapy and Occupational Therapy

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

Study groups in NCT03528395
Study groupRoleWhat they receive
Semi-immersive virtual realityExperimental8 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 ®.
Receives: Other: Semi-immersive virtual reality
Conventional RehabilitationActive comparatorPhysical therapy and Occupational Therapy based on a task-oriented approach
Receives: Other: Conventional Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: eight weeks

Secondary outcomes (8)

  1. Tinetti scale

    Scale validated in the context of stroke and whose score maximum for balance is 16 points, and 12 for gait. The higher the score, the lower risk of falls (less than 19 points on the scale total implies a high risk of falls; the risk is moderate with scores of 19 to 24).

    Measured: eight weeks

  2. Baropodometry

    The T-plate ® pedometer provides information on the pressure exerted by each point of the sole of the foot, distribution and plantar symmetry through a static test in the standing position. This test registers the center of pressures at a given moment, offering information on the distribution load (%) and the support surface.

    Measured: eight weeks

  3. Static Posturography

    Postural and static balance in standing was assessed through lateral and anteroposterior movement of the center of pressures in the x and y axes, in centimeters and square centimeters. Tests carried out were the Romberg test with open eyes, in which the patient remains on the platform and try to maintain balance during 30 seconds, and the Romberg test with eyes closed, in which the patient remains on the platform with closed eyes and tries to keep their balance for 30 seconds.

    Measured: eight weeks

  4. Functional reach test

    This test was used to detect alterations of the postural control and balance. The patient is placed standing holding the arm with the shoulder at 90 ° flexion, with a clenched fist, then realizes a maximum anterior reach without moving the feet of the ground. The maximum forwards distance without any supports is measured. A rigid tape measure with a leveler was used of a rule and bubble level calibrated bubble adhered to a mirror located on the wall. Patients able to perform this test were located with the healthy side next to the mirror, without direct contact. The result is registered in centimeters, measuring the distance between the initial and final position.

    Measured: eight weeks

  5. Modified Rankin scale

    Assesses the degree of physical disability after a stroke assigning a subjective score from 1 to 5. It is a very useful tool, validated and translated, to categorize functional level. It was used as a valuation tool pre and post intervention to describe changes in the level of functional independence of the patient after the experimental intervention.

    Measured: eight weeks

  6. Barthel index

    In order to assess functional independence, the Barthel index, indicated to evaluate the activities of daily life and validated in the Stroke context, translated and adapted to Spanish. It consists of 10 items with a range of score between 0 and 100 (with lower score, greater dependency).

    Measured: eight weeks

  7. EQ-5D Questionnaire

    The quality of life related to health was evaluated through the EuroQoL 5D. It is a test self-administered, generic, adapted to Spanish, in which health status is assessed in five dimensions (mobility, personal care, activities daily, pain / discomfort and anxiety / depression), and includes an optimal visual analog scale to assess the state of health at the time of registration (0-100).

    Measured: eight weeks

  8. Cano-Mañas scale

    The level of motivation, self-esteem and adherence to intervention was assessed using the Cano- Mañas. It is a Likert scale prepared by the research team and made since there is no validated instrument and translated that met the specific needs required. The first week of intervention was administered experimental and at the end of the eight weeks. It included 16 items (five motivation items, five of self-esteem and six of adhesion to the intervention). The scores were measured between 1 and 6: 1- very much in agreement; 5- strongly disagree; and 6-I have no opinion.

    Measured: eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2018
  2. Study start20 May 2017
  3. Primary completion20 Nov 2018
  4. Study completion7 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528395
Sponsor's protocol ID
HP FUENFRÍA
Status last verified
May 2018
First submitted
5 May 2018
Last updated
25 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28990643

  • 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.

    PubMed 32148744

Questions about this trial

What is this clinical trial studying?

A study testing Semi-immersive virtual reality and Conventional Rehabilitation in people with Stroke, run by Hospital La Fuenfría at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed get up and go (time frame: eight weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03528395, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.

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