Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

February 2, 2017 updated by: Sofia Straudi, MD, University Hospital of Ferrara

"Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".

Traumatic brain injury is an extremely common disease, it counts 50.000 deaths and 235.000 hospitalizations every year. Functional consequences of an acquired brain injury have a considerable impact on quality of lives of patients and care-givers with direct effects on balance, mobility and on psycho-social functions. Attention deficits are one of the most frequent and disabling consequences of severe brain injury. Within the wide spectrum of attentive problems, patients with traumatic brain injury frequently have shown difficulties in divided attention. Patients, care-givers and professionals frequently refer difficulties also in selective attention and vigilance as consequence of the trauma. It has been shown how these difficulties are tightly related with the missed return to work after two years from the injury.

The hypothesis of this study is to investigate the feasibility of a rehabilitative protocol on gaming using the console Xbox and its efficacy in improving balance, mobility, risk of falling, attentive functions (selective and divided attention) in subjects which have had a traumatic brain injury at least 12 months before.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

Chronic traumatic brain injury (>12 months) Age>18, <70 years old Presence of a moderate balance deficit identified by CB&M with a score < 65 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau<37).

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy
        • Ferrara University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic traumatic brain injury (>12 months)
  • Age>18, <70 years old
  • Presence of a moderate balance deficit identified by UBS with a score>15 and < 60 or presence of a selective attention and shifting attention deficit identified by the TEA computerized battery (Tau<37).

Exclusion Criteria:

  • Neurologic diseases associated with possible involvement of motor functions
  • Medical conditions that could interfere with the safe conclusion of the study protocol
  • Severe cognitive-behavioural diseases (LCF<6),
  • severe psychiatric diseases
  • Use of walking aids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gaming therapy (Xbox)
Subjects belonging to the first group will receive a gaming therapy protocol using the Xbox console. They will receive 24 sessions of treatment within 8 weeks (3 sessions per week). Patients will be required to concentrate in games whose major purposes are increasing balance, selective attention and attention shifting. During sessions the patient will be carefully controlled by a researcher who will prevent the risk of falling and impulsiveness reactions.
Device: gaming therapy (Xbox)
Active Comparator: Dynamic balance platform training
Control group will receive the same amount of therapy (24 sessions) using a dynamic balance platform (Biodex).
Device: Dynamic balance platform (Biodex)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in balance with Community Balance & Mobility Scale (CB&M)
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG)
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Unified Balance Scale (UBS)
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Participation Objective, Participation Subjective Scale(POPS)
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
postural sway
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Center of pressure (COP) trajectories
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Attentive functions evaluation Attentive functions evaluation
Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
TEA computerized battery
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Nino Basaglia, MD, Ferrara University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kinect_study
  • Kinect (Other Identifier: Ferrara University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on gaming therapy (Xbox)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe