Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

NCT01883830 | Completed DMC

• 2 other identifiers: Kinect_studyKinect
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Balance Disorders; Attention Deficits

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Participation Objective, Participation Subjective Scale(POPS)

  1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

• postural sway

  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.

Study Arms (2)

gaming therapy (Xbox)

EXPERIMENTAL

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)

Dynamic balance platform training

ACTIVE COMPARATOR

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

Device: Dynamic balance platform (Biodex)

Interventions

gaming therapy (Xbox) DEVICE

gaming therapy (Xbox)

Dynamic balance platform (Biodex) DEVICE

Dynamic balance platform training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, Italy, Italy

Location

Related Publications (1)

• 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.

  PMID: 28490322 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Nino Basaglia, MD

  Ferrara University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation doctor

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: June 21, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

IT (1)