Cerebral Palsy Clinical Trial
Official title:
Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual cycling training (VCT) program for lower limb was to enhance promising muscle strength through promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of whole hand is a novel technique and is commonly used to treatment of spasticity for patients with stroke. Constraint-induced therapy (CIT) is a method for treating developmental disregard and learned non-use of affected limb and improving motor efficiency, functional performance, and activities of daily living for patients with CP.
This study will proposed 3 novel protocols, including upper extremity (UE) VCT, UE SES, and
virtual reality based CIT (VRCIT) in the treatment of upper limb dysfunction in patients with
CP. investigators hypothesize that the functioning and health-related quality of life (HRQOL)
will improve through biomechanical and physiological changes after different treatment
protocols in patients with CP. The biomechanical and physiological changes varied depending
on different treatment protocols. This project aims to: 1. the immediate effects of new
protocols in these patients through biomechanical, physiological, and clinical measures; 2.
the maintaining effects of new protocols in these patients through biomechanical,
physiological, and clinical measures;3. the most effective treatment protocol; 3. the
biomechanical and physiological mechanism underlying clinical improvement; and 5. the
clinical predictors influencing the outcome for new protocols.
This 4-year project will recruit an estimated 92-100 patients with CP. A blind, randomized
controlled trial (RCT) study was designed. In the phase I (1st year), investigators will
set-up the experimental protocols and perform pilot study. Twenty patients will be randomized
into 4 groups: SES, VCT, VRCIT, and shame control groups. In the phase II (2nd -3rd year),
36-40 patients will be randomized into 2 groups: SES and shame control groups. In the phase
III (3rd -4th year), 36-40 patients will be randomized into 2 groups:VCT and VRCIT groups.
The outcome measures include biomechanical, physiological (muscle tone, muscle strength and
endurance, kinematics, bone density, body compositions, metabolism), and clinical
assessments, including functioning (motor impairment, movement and participation) and HRQOL,
based on the International Classification of Functioning, Disability and Health (ICF)
framework. The outcome measures will be administered at before, immediately after 12-week
intervention, and 3-month follow-up assessments.
This project is significant for the translational and evidence-based medicine on CP
neurorehabilitation. The research will offer valuable biomechanical and physiological
biomarker that support motor control models proposed to account for motor problems and new
protocol intervention in these patients.
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