Cerebral Palsy, SpasticNCT04394819
The Effect of Task-oriented EMG-triggered ES on Upper Limb Motor Function in Hemiplegic Cerebral Palsy
An observational study of Cerebral Palsy, Spastic, run by nihal tezel at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- electromyography-triggered electrical stimulation
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Task-oriented Electromyography-triggered Electrical Stimulation 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.
Read the 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.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- electromyography-triggered electrical stimulation
- Keywords
- cerebral palsy, task-oriented training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyography-triggered electrical stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: electromyography-triggered electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 months
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).
Measured: within 3 months
Secondary outcomes (2)
nine hole peg test (9-HPT)
9-HPT test is a standardized,quantitative assesment used to measure finger dexterity.
Measured: at the beginning, at the 5th week, and at the 3rd-month visit.
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).
Measured: at the beginning, at the 5th week, and at the 3rd-month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- nihal tezel
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, nihal tezel, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394819
- Sponsor's protocol ID
- DiskapiYBERHPTR
- Status last verified
- Mar 2024
- First submitted
- 6 May 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Task-oriented Electromyography-triggered Electrical Stimulation on Upper Limb Motor Function in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04394819
- Acronym / sponsor ID
- DiskapiYBERHPTR
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- cerebral palsy, task-oriented training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- nihal tezelOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental and control groups | – | Other: electromyography-triggered electrical stimulationTask-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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- primary care clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromyography-triggered electrical stimulationAll 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. | Other | experimental and control groups |
Primary outcome
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.
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).
2 secondary outcomes
nine hole peg test (9-HPT)
Time frame: at the beginning, at the 5th week, and at the 3rd-month visit.
hydraulic hand dynamometer
Time frame: at the beginning, at the 5th week, and at the 3rd-month visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Electromyography-Triggered Electrical Muscle Stimulation for Children with Cerebral Palsy: A Pilot StudyLink provided by the sponsor.
- Electrical stimulation in cerebral palsy: a review of effects on strength and motor functionLink provided by the sponsor.
- Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsyLink provided by the sponsor.
- Therapeutic functional electrical stimulation in hemiplegic cerebral palsyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic, run by nihal tezel at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cerebral Palsy Quality of Life Questionnaire (CPQoL) (time frame: within 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.