Clinical trial NCT02039284: Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Official title: Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
novel intervention
sensory electrical stimulation
virtual reality
cycling training
constraint-induced therapy
biomechanical
physiology
outcome
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-01-17
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV
2. aged 3-20 years
3. ability to undergo clinical assessment
4. ability to comprehend commands and cooperate during an examination

Exclusion Criteria:

1. chromosomal abnormalities
2. progressive neurological disorder or severe concurrent illness or disease not typically associated with CP
3. active medical conditions such as pneumonia or poor physical conditions that would interfere with participation
4. any major surgery or nerve block in the preceding 3 months
5. metabolic or hormonal disturbance
6. cardiovascular disorder
7. poor tolerance or a poor cooperation during assessment

Primary outcomes:
measure: change from baseline of muscle tone of the upper limb muscles in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of Basic motor abilities in 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: change from baseline of basic motor functions in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of quality of life in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of activities of daily living (ADL) in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of participation in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24 weeks
measure: change from baseline of bone mineral density in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of Metabolism and Body composition in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of kinematic analysis in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
measure: change from baseline of muscle strength and endurance in 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: change from baseline of severity in 12 and 24 weeks
timeFrame: baseline, 12 weeks, 24 weeks
measure: change from baseline of reaction-time in 12 and 24 weeks
timeFrame: baseline, 12 weeks ,24 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD,PhD
role: STUDY_DIRECTOR
References: