Clinical trial NCT03048851: Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
Official title: Immediate and Maintaining 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
sensory electrical stimulation
virtual reality constraint-induced therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: * 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

Primary outcomes:
measure: change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks
timeFrame: baseline, 12weeks, 24weeks
Secondary outcomes:
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 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: