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Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Balance Disorders, Attention Deficits

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
gaming therapy (Xbox)
Dynamic balance platform (Biodex)
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury (TBI), balance disorders, attention deficits, x-box, gaming, virtual reality

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ferrara University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gaming therapy (Xbox)

Dynamic balance platform training

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in balance with Community Balance & Mobility Scale (CB&M)

Secondary Outcome Measures

Timed Up and Go (TUG)
Unified Balance Scale (UBS)
Participation Objective, Participation Subjective Scale(POPS)
postural sway
Center of pressure (COP) trajectories
Attentive functions evaluation Attentive functions evaluation
TEA computerized battery

Full Information

First Posted
April 5, 2013
Last Updated
February 2, 2017
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT01883830
Brief Title
Xbox in the Rehabilitation of Chronic Traumatic Brain Injury
Official Title
"Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Balance Disorders, Attention Deficits
Keywords
traumatic brain injury (TBI), balance disorders, attention deficits, x-box, gaming, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaming therapy (Xbox)
Arm Type
Experimental
Arm Description
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.
Arm Title
Dynamic balance platform training
Arm Type
Active Comparator
Arm Description
Control group will receive the same amount of therapy (24 sessions) using a dynamic balance platform (Biodex).
Intervention Type
Device
Intervention Name(s)
gaming therapy (Xbox)
Intervention Type
Device
Intervention Name(s)
Dynamic balance platform (Biodex)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Timed Up and Go (TUG)
Time Frame
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Title
Unified Balance Scale (UBS)
Time Frame
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Title
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.
Title
postural sway
Description
Center of pressure (COP) trajectories
Time Frame
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Title
Attentive functions evaluation Attentive functions evaluation
Description
TEA computerized battery
Time Frame
1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD
Organizational Affiliation
Ferrara University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28490322
Citation
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.
Results Reference
derived

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Xbox in the Rehabilitation of Chronic Traumatic Brain Injury

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