The Effect of Task-oriented EMG-triggered ES on Upper Limb Motor Function in Hemiplegic Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

Official title:

The Effect of Task-oriented Electromyography-triggered Electrical Stimulation on Upper Limb Motor Function in Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394819
• Other study ID #: DiskapiYBERHPTR
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Paralysis

Intervention

Other:
• electromyography-triggered electrical stimulation
All treatments were planned as 2 sessions per week, for a total of 10 sessions for 5 weeks. For EMG-trigger-ES application, dual-channel Nu-Tek® brand, Maxi plus 2 Model EMG-trigger-BF-ES Device in our clinic was planned to be used. With EMG-triggered-ES application, while the patient is in a sitting position, shoulder adduction, and the elbow is 90 degrees of flexion and pronation, the patient will extend to the ball of 5 cm in diameter, which is placed as far as the distance between the acromion and the 3rd toe, and then the finger-wrist active extension will be stimulated and then It was planned to apply the ball to be grasped. One of the two 5x5 cm superficial square electrodes of the device was planned to be placed on the extensor carpi radialis and extensor digitorum Communis and the other 2 cm distal.

Locations

Country	Name	City	State
Turkey	DiskapiYBERH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
nihal tezel

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cerebral Palsy Quality of Life Questionnaire (CPQoL)	Health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP). It consists of a caregiver and a child survey. It is used for the evaluation of Sp cases between the ages of 4-12.	within 3 months
Primary	Action Research Arm Test (ARAT)	The ARAT consists of four subscales: grasp, grip, pinch, and gross movement. It contains 19 tasks, and each task is scored on a four-point scale (0, can perform no part of the test; 1, performs test partially; 2, completes test but takes abnormally long time or has great difficulty; and 3, performs test normally).	within 3 months
Secondary	nine hole peg test (9-HPT)	9-HPT test is a standardized,quantitative assesment used to measure finger dexterity.	at the beginning, at the 5th week, and at the 3rd-month visit.
Secondary	hydraulic hand dynamometer	Patients were encouraged to press as firmly as possible. Three consecutive measurements were performed. The average of the measurements was recorded in kilogram (kg).	at the beginning, at the 5th week, and at the 3rd-month visit.

External Links

•   Electrical stimulation in cerebral palsy: a review of effects on strength and motor function
•   Electromyography-Triggered Electrical Muscle Stimulation for Children with Cerebral Palsy: A Pilot Study
•   Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy
•   Therapeutic functional electrical stimulation in hemiplegic cerebral palsy