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Completed

NCT Number: NCT01883830

Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Attention Deficits Balance Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ferrara University Hospital

Ferrara, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gaming therapy (Xbox)

Device

Dynamic balance platform (Biodex)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Timed Up and Go (TUG)

    Time frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

  2. Unified Balance Scale (UBS)

    Time frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2013
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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