Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): SES; VCT; VRCIT; traditional rehabilitation program
Intervention type(s): Device; Device; Device; Device
Intervention description(s): SES group received the SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted three times per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove for 20-30 minutes and arm with wrap for 20-30 minutes. The pulse width was set to 300 us for all stimulation levels. The frequency was set to 40-50 Hz.; The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.; VRCIT group received the VRCIT training in addition to traditional rehabilitation, conducted three times per week, for 12 weeks. Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, in addition to home program, and restraint of the less affected UE for 3.5 to 4 hours per day. The functional training of the more affected UE focused on massive practice of functional activities using the more affected arm, with the principles of shaping and repetitive task practice applied during training.; The absence of muscle contractions was controlled by the investigator the sham stimulation was carried out identically, but the stimulation amplitude was set to 0 milliampere(mA). Subjects were not informed about the stimulation level and were instructed to distract attention from the stimulation.
Other intervention name(s): novel sensory electrical stimulation program; The upper extremity programsvirtual cycling training program; virtual reality based Constraint-induced therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; novel intervention; sensory electrical stimulation; virtual reality; cycling training; constraint-induced therapy; biomechanical; physiology; outcome