Clinical trial NCT04394819: The Effect of Task-oriented EMG-triggered ES on Upper Limb Motor Function in Hemiplegic Cerebral Palsy
Official title: The Effect of Task-oriented Electromyography-triggered Electrical Stimulation on Upper Limb Motor Function in Hemiplegic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Spastic
Keywords: cerebral palsy
task-oriented training
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of our study; to investigate the effects of EMG-induced ES treatment on hand functions, muscle strength, and quality of life in patients with hemiplegic CP.

Detailed description: Upper limb spasticity greatly affects the hand functions of patients with cerebral palsy (CP) and impairs quality of life. The most important goal in rehabilitation; despite the existing deficiencies, the highest level of functional independence of the patient is to increase the quality of life. EMG-triggered biofeedback electrical stimulation (EMG-triggered-BF-ES) increases the patient's active participation and motivation in rehabilitation, creates visual or auditory BF, provides muscle reeducation, decreases spasticity, prevents atrophies and increases joint mobility and increases muscle functionality by increasing the patient's functionality. There are areas of use the EMG-triggered-BF-ES such as cerebrovascular disease (CVO), spinal cord injury, and CP. When the literature is examined; studies were found to be few, and no study evaluating the upper extremity was found in children with CP. The purpose of our study is the investigation of the effects of EMG-triggered-BF-ES treatment applied on hand functions, muscle strength, and quality of life in patients with CP.

Eligibility criteria: Inclusion Criteria:

* having a diagnosis of CP
* age between 4 and 18 year
* at least 10° of the active wrist and finger extension in the affected limb but less than normal
* upper limb spasticity (shoulder, elbow, wrist, and fingers) less than or equal to grade 2 according to the modified Ashworth scale (MAS)
* should be able to receive command

Exclusion Criteria:

* Mental retardation
* Passive range of motion (ROM) limitation in the upper extremity
* Sensory impairment in the upper extremity
* The visual and auditory deficit in the upper extremity
* MAS is more than 3.
* Botulinum toxin application to the upper limb in the last 6 months
* Any surgical application to the upper limb in the last 6 months

Primary outcomes:
measure: The Cerebral Palsy Quality of Life Questionnaire (CPQoL)
timeFrame: within 3 months
measure: Action Research Arm Test (ARAT)
timeFrame: within 3 months
Secondary outcomes:
measure: nine hole peg test (9-HPT)
timeFrame: at the beginning, at the 5th week, and at the 3rd-month visit.
measure: hydraulic hand dynamometer
timeFrame: at the beginning, at the 5th week, and at the 3rd-month visit.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: DiskapiYBERH
Study officials:
References: