The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury. The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury. The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient.
IRCCS Eugenio Medea
Bosisio Parini, LC, Italy
RECRUITINGJoint Stiffness of affected upper limb joint
Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better.
Time frame: After 4 weeks of treatment
Modified Ashworth Scale
Clinical scale for spasticity (5 levels), higher is worse.
Time frame: After 4 weeks of treatment
Melbourne Upper Limb Assessment 2
Clinical scale for evaluating quality of upper limb movement (16 items, each assessed from 0 to 4 points). Result reported in %. Higher is better.
Time frame: After 4 weeks of treatment
Quality of Upper Extremity Skills Test
Clinical scale evaluating the quality of upper extremity function (33 items, 4 domains). Minimum score 0, maximum score 100. Higher is better.
Time frame: After 4 weeks of treatment
Active range of motion
Measured with goniometer in degrees.
Time frame: After 4 weeks of treatment
Passive range of motion
Measured with goniometer in degrees.
Time frame: After 4 weeks of treatment
Range of motion of target joint during a pointing-forward task
Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system.
Time frame: After 4 weeks of treatment
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