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

NCT ID: NCT04394819

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy, Spastic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental and control groups

Task-oriented EMG-triggered ES treatment will be applied to the experimental group 2 days a week for 5 weeks and will continue with conventional physiotherapy.

The control group will only continue conventional physiotherapy treatment.

electromyography-triggered electrical stimulation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

nihal tezel

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

nihal tezel

medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DiskapiYBERH

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

https://journals.lww.com/pedpt/Abstract/1991/00340/Electromyography_Triggered_Electrical_Muscle.4.aspx

Electromyography-Triggered Electrical Muscle Stimulation for Children with Cerebral Palsy: A Pilot Study

https://pubmed.ncbi.nlm.nih.gov/14995090

Electrical stimulation in cerebral palsy: a review of effects on strength and motor function

https://www.ncbi.nlm.nih.gov/pubmed/11104342

Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy

https://pubmed.ncbi.nlm.nih.gov/24185362

Therapeutic functional electrical stimulation in hemiplegic cerebral palsy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DiskapiYBERHPTR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.