Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury

Study Overview
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Brief Summary
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The affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. The use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. So that, the goal of this investigation is to evaluate the system use effectiveness of the Leap Motion Controller® in the treatment on the upper limb on patients with neurological disease.

Official Title
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Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury

Conditions
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Stroke, Treatment Adherence, Patient Satisfaction, Brain Injuries, Traumatic

Intervention / Treatment
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* Other: Conventional therapy
* Other: Leap motion plus conventional therapya


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people aged between 30 and 70 years old; with a confirmed diagnosis of brain damage (>6 months); UL motor impairment with a Fugl-Meyer score≥16; a modified Ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb Exclusion Criteria: the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the Mini-mental Test; refusal to participate in the study; visual impairment not correctable by glasses.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional therapy<br>Conventional physical therapy for upper limb in stroke patients | Other: Conventional therapy<br>* conventional physcial therapy rehabilitation for the upper limb<br>|
| Experimental: Leap motion plus conventional therapy<br>Leap motion plus conventional physical therapy for upper limb in stroke patients | Other: Leap motion plus conventional therapya<br>* leap motion plus conventional physcial therapy rehabilitation for the upper limb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) | Shoulder Pain - Physioplus Objective The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) | 8 weeks | 
| Jamar | Jamar® hydraulic hand dynamometer was used to measure grip strength. | 8 weeks | 
| Box and blocks | Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the therapy sessions | the attendance rate (%) for therapy sessions | 8 weeks | 
| Questionary of Patient Satifaction | which evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered | 8 weeks |