Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883830
• Other study ID #: Kinect_study
• Secondary ID: Kinect
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: February 2, 2017
• Start date: April 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficits
• Balance Disorders
• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• gaming therapy (Xbox)

• Dynamic balance platform (Biodex)

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

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