Traumatic Brain InjuryNCT01883830
Xbox in the Rehabilitation of Chronic Traumatic Brain Injury
A study testing gaming therapy (Xbox) and Dynamic balance platform (Biodex) in people with Traumatic Brain Injury and Balance Disorders, run by University Hospital of Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury, Balance Disorders, Attention Deficits
- What is being tested?
- gaming therapy (Xbox) and Dynamic balance platform (Biodex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".
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.
Read the 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).
- Being tested
- gaming therapy (Xbox), Dynamic balance platform (Biodex)
- Keywords
- traumatic brain injury (TBI), balance disorders, attention deficits, x-box, gaming, virtual reality
- Medical subject headings
- Brain Injuries, Traumatic, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaming therapy (Xbox)Device
Dynamic balance platform (Biodex)Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Dynamic balance platform (Biodex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in balance with Community Balance & Mobility Scale (CB&M)
Measured: 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)
Measured: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Unified Balance Scale (UBS)
Measured: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Participation Objective, Participation Subjective Scale(POPS)
Measured: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
postural sway
Center of pressure (COP) trajectories
Measured: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Attentive functions evaluation Attentive functions evaluation
TEA computerized battery
Measured: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
- Investigators
- Nino Basaglia, MD, Principal investigator, Ferrara University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883830
- Sponsor's protocol ID
- Kinect_study
- Other IDs
- Kinect
- Status last verified
- Feb 2017
- First submitted
- 5 Apr 2013
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28490322
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Feasibility and Efficacy of Virtual Reality With Xbox Kinect in the Rehabilitation of Cronic Traumatic Brain Injuries: a Randomized Controlled Trial".
- ClinicalTrials.gov ID
- NCT01883830
- Acronym / sponsor ID
- Kinect_study
- Keywords
- traumatic brain injury (TBI), balance disorders, attention deficits, x-box, gaming, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gaming therapy (Xbox) | Experimental | Device: 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. |
| Dynamic balance platform training | Active comparator | Device: Dynamic balance platform (Biodex)Control group will receive the same amount of therapy (24 sessions) using a dynamic balance platform (Biodex). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gaming therapy (Xbox) | Device | gaming therapy (Xbox) |
| Dynamic balance platform (Biodex) | Device | Dynamic balance platform training |
Primary outcome
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.
5 secondary outcomes
Timed Up and Go (TUG)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Unified Balance Scale (UBS)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
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.
postural sway
Time frame: 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 28490322Straudi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Basaglia, MD principal investigator
Ferrara University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaming therapy (Xbox) and Dynamic balance platform (Biodex) in people with Traumatic Brain Injury and Balance Disorders, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.