Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Balance Disorders; Traumatic Brain Injury; Attention Deficits
• Interventions: Device: gaming therapy (Xbox); Device: Dynamic balance platform (Biodex)

• Registration Number: NCT01883830
• Lead Sponsor: University Hospital of Ferrara

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).

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gaming therapy (Xbox)	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.
Dynamic balance platform training	Dynamic balance platform (Biodex)	Control group will receive the same amount of therapy (24 sessions) using a dynamic balance platform (Biodex).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy