Clinical trial NCT01883830: Xbox in the Rehabilitation of Chronic Traumatic Brain Injury
Official title: "Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Balance Disorders
Attention Deficits
Keywords: traumatic brain injury (TBI)
balance disorders
attention deficits
x-box
gaming
virtual reality
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in balance with Community Balance & Mobility Scale (CB&M)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
measure: Unified Balance Scale (UBS)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
measure: Participation Objective, Participation Subjective Scale(POPS)
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
measure: postural sway
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
measure: Attentive functions evaluation Attentive functions evaluation
timeFrame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara University Hospital
name: Nino Basaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Straudi S, Severini G, Sabbagh Charabati A, Pavarelli C, Gamberini G, Scotti A, Basaglia N. The effects of video game therapy on balance and attention in chronic ambulatory traumatic brain injury: an exploratory study. BMC Neurol. 2017 May 10;17(1):86. doi: 10.1186/s12883-017-0871-9.