Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital of Ferrara
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT01883830
First received: April 5, 2013
Last updated: September 22, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Balance Disorders
Attention Deficits
Device: gaming therapy (Xbox)
Device: Dynamic balance platform (Biodex)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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".

Resource links provided by NLM:


Further study details as provided by University Hospital of Ferrara:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed Up and Go (TUG) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up. ] [ Designated as safety issue: No ]
  • Unified Balance Scale (UBS) [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • postural sway [ Time Frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up. ] [ Designated as safety issue: No ]
    Center of pressure (COP) trajectories

  • 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. ] [ Designated as safety issue: No ]
    TEA computerized battery


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883830

Contacts
Contact: Claudia Pavarelli, PT 00390532238720 claudiapavarelli@yahoo.it
Contact: Sofia Straudi, MD 00390532238721 s.straudi@gmail.com

Locations
Italy
Ferrara University Hospital Recruiting
Ferrara, Italy
Contact: Sofia Straudi, MD    00390532238720    s.straudi@ospfe.it   
Sub-Investigator: Claudia Pavarelli, PT         
Sub-Investigator: Antonella Bergonzoni, MD         
Sub-Investigator: Giacomo Severini, PhD         
Sub-Investigator: Roberta Benasciutti, ST         
Principal Investigator: Nino Basaglia, MD         
Sub-Investigator: Amira Sabbagh Charabati, PT         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
Principal Investigator: Nino Basaglia, MD Ferrara University Hospital
  More Information

No publications provided

Responsible Party: Sofia Straudi, MD, Physical Medicine and Rehabilitation doctor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01883830     History of Changes
Other Study ID Numbers: Kinect_study, Kinect
Study First Received: April 5, 2013
Last Updated: September 22, 2014
Health Authority: Italy: Ferrara Ethics Committee

Keywords provided by University Hospital of Ferrara:
traumatic brain injury (TBI)
balance disorders
attention deficits
x-box
gaming
virtual reality

Additional relevant MeSH terms:
Brain Injuries
Attention Deficit Disorder with Hyperactivity
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014