Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Immediate and Maintaining Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048851
• Other study ID #: 103-7425A3
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: October 2019

Study information

• Verified date: August 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 24 Years

Eligibility

• Inclusion Criteria:

• Diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV

• Aged 2-24 years

• Ability to undergo clinical assessment

• Ability to comprehend commands and cooperate during an examination

• Exclusion Criteria:

• Chromosomal abnormalities

• Progressive neurological disorder or severe concurrent illness or disease not typically associated with CP

• Active medical conditions such as pneumonia or poor physical conditions that would interfere with participation

• Any major surgery or nerve block in the preceding 3 months

• Metabolic or hormonal disturbance

• Cardiovascular disorder

• Poor tolerance or a poor cooperation during assessment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• Low dosage SES group
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.
• High dosage SES group
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.
• VRCIT group
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.
• VRCIT+SES group
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).

Procedure:
• traditional rehabilitation program
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks	Muscle tone of the upper limb muscles assessment by Modified Ashworth Scale and Myoton (© 2011 Myoton AS.). Basic motor abilities included the assessments of the Bruininks-Oseretsky Test of Motor Proficiency II (BOT II), Melbourne Assessment 2 (MA2), Quality of upper extremity skills test (QUEST). The measure is a composite.	baseline, 12weeks, 24weeks
Secondary	change from baseline of quality of life in 12 and 24 weeks	The health-related quality of life(HRQOL) assess by Cerebral Palsy Quality of Life (CP QOL) for Child and adolescent. The CP QOL is a measure of HRQOL specific to children and adolescent with cerebral palsy.	baseline, 12weeks, 24weeks
Secondary	change from baseline of activities of daily living (ADL) in 12 and 24 weeks	The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL). The measure is a composite.	baseline, 12weeks, 24weeks
Secondary	change from baseline of bone mineral density in 12 and 24 weeks	he areal bone mineral density (aBMD) (g/cm2) will be measured at the lumbar spine (L1 to L4) and the humerus of the more-affected limb using dual X-ray absorptiometry (DXA).	baseline, 12weeks, 24weeks
Secondary	change from baseline of Metabolism and Body composition in 12 and 24 weeks	The measure included the total energy expenditure (kcal/min), active energy expenditure (kcal/min), total number of steps, physical activity levels and duration, sleep duration and efficiency, weight, total body water, skeletal muscle mass (SMM), body fat mass (BFM), fat free mass, percent body fat, waist-hip ratio (WHR), and basal metabolic rate (BMR) by the devices of SenseWear(© 2013 BodyMedia, Inc.) and Body Composition Analyzer(InBody230). The measure is a composite.	baseline, 12weeks, 24weeks
Secondary	change from baseline of kinematic analysis in 12 and 24 weeks	Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite.	baseline, 12weeks, 24weeks
Secondary	change from baseline of muscle strength and endurance in 12 and 24 weeks	The device (Hoggan-5081) for kinetic analysis combined range of motion (ROM), muscle testing (MicroFET3) and grip and pinch gauge (MicroFET4) and data capture software, attached to a computer for more thorough testing. MicroFET4 combined pinch gauge and grip tester in a single device with high test-retest reliability. The Grip Test included Maximum Grip Test, 5 Position Grip Test, Rapid Exchange Grip Test, Hand Grip Fatigue Test. The Pinch Test included key Pinch, palmar Pinch, and tip pinch. MicroFET3 combined Muscle Tester and ROM Gauge. Peak force and average strength were obtained. The padded attachment that was fit in the palm of the hand allowed the administrators to provide direct resistance to movement of the extremity. For arm strength test, the examiner manually stabilized the body parts proximal to the tested limb segment during testing and asked participants to exert a maximal isometric muscle contraction lasting 3-seconds while the dynamometer was held stationary.	baseline, 12 weeks, 24 weeks
Secondary	change from baseline of severity in 12 and 24 weeks	The severity is evaluated by Gross Motor Function Classification System(GMFCS), Manual Ability Classification System (MACS).The assessments for body function included Modified Ashworth Scale (MAS), strength, endurance, and trunk and limb involvement, etc. The measure is a composite.	baseline, 12 weeks, 24 weeks
Secondary	change from baseline of reaction-time in 12 and 24 weeks	To examine the reaction time by CANTAB® software.	baseline, 12 weeks ,24 weeks