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: 
      Immediate and maintaining Efficacy of new protocols in the treatment of upper limb
      dysfunctions in patients with cerebral palsy.
    

Detailed description: 
      Cerebral palsy (CP) is the most common childhood motor disability. Spasticity and loss of
      dexterity are the major problems for motor disability of upper extremity (UE) in patients
      with CP. This study propose two novel treatment protocols: sensory electrical stimulation
      (SES) and virtual reality constraint-induced therapy (VRCIT) to improve function of UE in
      patients with CP. Investigators hypothesize that combined SES and VRCIT treatment have better
      effect than single therapy (SES or VRCIT).
    

Intervention name(s): Low dosage SES group; High dosage SES group; VRCIT group; VRCIT+SES group; traditional rehabilitation program
Intervention type(s): Device; Device; Device; Device; Procedure
Intervention description(s): The participants were randomly assigned to one of the five intervention groups. Low dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) 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 twice 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 (Electro-Mesh Glove-Sleeve Electrode Kit) for 45 minutes and arm with wrap for 45 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.; The participants were randomly assigned to one of the five intervention groups. High dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) 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 twice 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 (Electro-Mesh Glove-Sleeve Electrode Kit) for 90 minutes and arm with wrap for 90 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.; The participants were randomly assigned to one of the five intervention groups. VRCIT group received the VRCIT training plus traditional rehabilitation, conducted twice 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, plus home program, and restraint of the less affected UE for 1.5 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 VRCIT combined CIT and commercially available VR-based systems including Sony Playstation EyeToy and Nintendo Wii.; The participants were randomly assigned to one of the five intervention groups. VRCIT+SES group executed VR programs by affected UE in Mesh-gloves (Electro-Mesh Glove-Sleeve Electrode Kit) with the optimal SES (Micro-Z Mini, Prizm Medical Inc., USA) protocol formulated from the 1st phase study. The VRCIT program was conducted 1.5 hours/time, twice/week for 12 weeks. The VRCIT combined CIT and commercially available VR-based systems. Some commercially programs, such as Sony Playstation EyeToy (Sony Computer Entertainment America, Foster City, Calif., USA), and Nintendo Wii (Nintendo Domestic Distributor, College Point, N.Y., USA).; The participants were randomly assigned to one of the five intervention groups. 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; novel sensory electrical stimulation program; virtual reality based Constraint-induced therapy; combined VR based Constraint-induced therapy & SES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; sensory electrical stimulation; virtual reality constraint-induced therapy