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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01883830
Other study ID # Kinect_study
Secondary ID Kinect
Status Completed
Phase N/A
First received April 5, 2013
Last updated February 2, 2017
Start date April 2013
Est. completion date May 2016

Study information

Verified date February 2017
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
gaming therapy (Xbox)

Dynamic balance platform (Biodex)


Locations

Country Name City State
Italy Ferrara University Hospital Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Timed Up and Go (TUG) 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Secondary Unified Balance Scale (UBS) 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Secondary Participation Objective, Participation Subjective Scale(POPS) 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Secondary postural sway Center of pressure (COP) trajectories 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
Secondary Attentive functions evaluation Attentive functions evaluation TEA computerized battery 1)A week prior to treatment beginning 2) the week after treatment 3)three months follow up.
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