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Completed

NCT Number: NCT04394819

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

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DiskapiYBERH

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electromyography-triggered electrical stimulation

Other

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.

Primary outcomes

  1. The Cerebral Palsy Quality of Life Questionnaire (CPQoL)

    Time frame: within 3 months

    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.

  2. Action Research Arm Test (ARAT)

    Time frame: within 3 months

    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).

Secondary outcomes

  1. nine hole peg test (9-HPT)

    Time frame: at the beginning, at the 5th week, and at the 3rd-month visit.

    9-HPT test is a standardized,quantitative assesment used to measure finger dexterity.

  2. hydraulic hand dynamometer

    Time frame: at the beginning, at the 5th week, and at the 3rd-month visit.

    Patients were encouraged to press as firmly as possible. Three consecutive measurements were performed. The average of the measurements was recorded in kilogram (kg).

Sponsors and collaborators

Lead sponsor

nihal tezel

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 19, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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