Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT01883830
• Recruitment Status: Completed
• First Posted: June 21, 2013
• Last Update Posted: February 3, 2017
• Sponsor: University Hospital of Ferrara
• Information provided by (Responsible Party): Sofia Straudi, MD, University Hospital of Ferrara

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury; Balance Disorders; Attention Deficits	Device: gaming therapy (Xbox); Device: Dynamic balance platform (Biodex)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Ferrara University Hospital

Ferrara, Italy

Sponsors and Collaborators

University Hospital of Ferrara

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sofia Straudi, MD, Physical Medicine and Rehabilitation doctor, University Hospital of Ferrara
• ClinicalTrials.gov Identifier: NCT01883830
• Other Study ID Numbers: Kinect_study; Kinect ( Other Identifier: Ferrara University Hospital )
• First Posted: June 21, 2013
• Last Update Posted: February 3, 2017
• Last Verified: February 2017

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:

traumatic brain injury (TBI); balance disorders; attention deficits; x-box; gaming; virtual reality

Additional relevant MeSH terms:

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