Xbox in the Rehabilitation of Chronic Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT01883830|
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : February 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Balance Disorders Attention Deficits||Device: gaming therapy (Xbox) Device: Dynamic balance platform (Biodex)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||"Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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)
- 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. ]
- Timed Up and Go (TUG) [ Time Frame: 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. ]
- 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. ]
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883830
|Ferrara University Hospital|
|Principal Investigator:||Nino Basaglia, MD||Ferrara University Hospital|