Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528395
• Other study ID #: HP FUENFRÍA
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: March 7, 2019

Study information

• Verified date: May 2018
• Source: Hospital La Fuenfría
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 7, 2019
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Semi-immersive virtual reality
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 Rehabilitation
Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.

Locations

Country	Name	City	State
Spain	Hospital La Fuenfría	Cercedilla	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital La Fuenfría	Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks
Secondary	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.	eight weeks
Secondary	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).	eight weeks
Secondary	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).	eight weeks
Secondary	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.	eight weeks