Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

NCT ID: NCT01883830

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-05-31

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).

Conditions

Traumatic Brain Injury; Balance Disorders; Attention Deficits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

gaming therapy (Xbox)

Intervention Type: DEVICE

Dynamic balance platform training

Control group will receive the same amount of therapy (24 sessions) using a dynamic balance platform (Biodex).

Group Type: ACTIVE_COMPARATOR

Dynamic balance platform (Biodex)

Intervention Type: DEVICE

Interventions

gaming therapy (Xbox)

Intervention Type: DEVICE

Dynamic balance platform (Biodex)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi, MD

Physical Medicine and Rehabilitation doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nino Basaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Ferrara University Hospital

Locations

Ferrara University Hospital

Ferrara, Italy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28490322 (View on PubMed)

Other Identifiers

Kinect

Identifier Type: OTHER

Identifier Source: secondary_id

Kinect_study

Identifier Type: -

Identifier Source: org_study_id