Cerebral PalsyNCT07622875
Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy
A study testing Multimodal Rehabilitation and Transcutaneous diaphragmatic electrical stimulation (TDES) in people with Cerebral Palsy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Does transcutaneous diaphragmatic electrical stimulation (TDES), added to a 6-week structured multimodal rehabilitation program, improve diaphragm function, head-neck control, and sitting balance in children with cerebral palsy at GMFCS Level IV-V? Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Multimodal Rehabilitation and Transcutaneous diaphragmatic electrical stimulation (TDES)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Cerebral Palsy (GMFCS Level IV-V)
- Aged 5-18 years
Who cannot join
- Clinically unstable condition,
- Tracheostomy, home-based non-invasive mechanical ventilation (CPAP/BIPAP), continuous oxygen therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Transcutaneous Diaphragmatic Electrical Stimulation Added to a Multimodal Rehabilitation Program on Pulmonary Functions in Non-Ambulatory Children With Cerebral Palsy
Does transcutaneous diaphragmatic electrical stimulation (TDES), added to a 6-week structured multimodal rehabilitation program, improve diaphragm function, head-neck control, and sitting balance in children with cerebral palsy at GMFCS Level IV-V?
Read the detailed description
Baseline clinical and demographic data of patients meeting the inclusion criteria will be recorded in detail. Subsequently, participants will be randomly assigned into two groups using a computer-generated randomization method. All patients will receive a 6-week multimodal rehabilitation program consisting of conventional exercises and electrical stimulation to the lower extremity muscles five days per week, in addition to 45-minute sessions of robotic rehabilitation, 45-minute occupational therapy, 45-minute hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly. The pulmonary rehabilitation program will include diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition to these treatments, patients in the intervention group will receive transcutaneous diaphragmatic electrical stimulation (TDES).
TDES will be administered by a blinded researcher using a four-channel, low-frequency biphasic neuromuscular electrical stimulator (Compex SP 4.0, Mouguerre, France). Rectangular electrodes will be positioned in the parasternal region adjacent to the xiphoid process and at the sixth and seventh intercostal spaces along the midaxillary line. Stimulation will be delivered using biphasic waves at a frequency of 30 Hz, a pulse width of 400 μs, and a ramp-up time of 0.7 seconds. Current intensity will be gradually increased, in accordance with established protocols, until visible diaphragmatic contractions are achieved. Intervention sessions will be administered twice weekly for 30 minutes per session over a 6-week period.
Assessments will be performed before rehabilitation (week 0) and after completion of the program (week 6) by a blinded researcher other than the investigator administering TDES. In children using braces due to scoliosis, all measurements will be performed without the brace.
The effects of TDES added to a multimodal rehabilitation program on pulmonary function, head-neck control, and sitting balance, as well as related factors, will be investigated in non-ambulatory children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Multimodal Rehabilitation, Transcutaneous diaphragmatic electrical stimulation (TDES)
- Keywords
- Cerebral Palsy, Electrical stimulation, Diaphragmatic, Respiratory muscle
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal RehabilitationBehavioural
Conventional exercises and electrical stimulation to the lower extremity muscles 5 days per week for 6 weeks, in addition to twice-weekly sessions of robotic rehabilitation, occupational therapy, hydrotherapy, and pulmonary rehabilitation program.
Transcutaneous diaphragmatic electrical stimulation (TDES)Device
TDES twice a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| MULTIMODAL REHABILITATION GROUP | Active comparator | In addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. Receives: Behavioral: Multimodal Rehabilitation |
| TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP | Active comparator | In addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition, patients in this group will receive transcutaneous diaphragmatic electrical stimulation (TDES) twice weekly for 30 minutes per session over a 6-week period. Receives: Behavioral: Multimodal Rehabilitation; Device: Transcutaneous diaphragmatic electrical stimulation (TDES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Function
Using ultrasound, the diaphragm thickness (mm) and the diaphragm thickening fraction (TF %) will be measured and evaluated. During the measurements, children will be positioned in the semi-Fowler's position (30-45°) or, in appropriate cases, in the supine position, and the measurements will be taken from the right hemidiaphragm. In the ultrasound examination, a high-frequency linear probe (8-10 MHz) will be advanced along the midclavicular line toward the midpoint of the anterior axillary line and positioned at the junction between the seventh and eighth costal cartilages. The thickness of the diaphragm, which appears hyperechoic on the outer surface and hypoechoic on the inner surface, will be measured at the end of inspiration and expiration. Children will not be asked to exert maximum effort during the measurement. The thickness of the diaphragm muscle will be measured at the end of expiration (Texp) and the end of inspiration (Tinsp).
TF (%) = (Tinsp - Texp) / Texp × 100
Measured: 6 weeks
Secondary outcomes (1)
Head-Neck Control and Sitting Balance
the A and B subdomains of the Gross Motor Function Measure-88 (GMFM-88). The Gross Motor Function Measure-88 (GMFM-88) Subscale A scores between 0 and 51, while Subscale B scores between 0 and 60; higher scores indicate better gross motor function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start15 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Kıraç Ünal, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622875
- Sponsor's protocol ID
- AnkaraEtlik-FTR-ZKU-01
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Diaphragmatic Electrical Stimulation Added to a Multimodal Rehabilitation Program on Pulmonary Functions in Non-Ambulatory Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07622875
- Acronym / sponsor ID
- AnkaraEtlik-FTR-ZKU-01
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Electrical stimulation, Diaphragmatic, Respiratory muscle
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jun 2026 (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.
Does transcutaneous diaphragmatic electrical stimulation (TDES), added to a 6-week structured multimodal rehabilitation program, improve diaphragm function, head-neck control, and sitting balance in children with cerebral palsy at GMFCS Level IV-V?
Detailed description
Baseline clinical and demographic data of patients meeting the inclusion criteria will be recorded in detail. Subsequently, participants will be randomly assigned into two groups using a computer-generated randomization method. All patients will receive a 6-week multimodal rehabilitation program consisting of conventional exercises and electrical stimulation to the lower extremity muscles five days per week, in addition to 45-minute sessions of robotic rehabilitation, 45-minute occupational therapy, 45-minute hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly. The pulmonary rehabilitation program will include diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition to these treatments, patients in the intervention group will receive transcutaneous diaphragmatic electrical stimulation (TDES).
TDES will be administered by a blinded researcher using a four-channel, low-frequency biphasic neuromuscular electrical stimulator (Compex SP 4.0, Mouguerre, France). Rectangular electrodes will be positioned in the parasternal region adjacent to the xiphoid process and at the sixth and seventh intercostal spaces along the midaxillary line. Stimulation will be delivered using biphasic waves at a frequency of 30 Hz, a pulse width of 400 μs, and a ramp-up time of 0.7 seconds. Current intensity will be gradually increased, in accordance with established protocols, until visible diaphragmatic contractions are achieved. Intervention sessions will be administered twice weekly for 30 minutes per session over a 6-week period.
Assessments will be performed before rehabilitation (week 0) and after completion of the program (week 6) by a blinded researcher other than the investigator administering TDES. In children using braces due to scoliosis, all measurements will be performed without the brace.
The effects of TDES added to a multimodal rehabilitation program on pulmonary function, head-neck control, and sitting balance, as well as related factors, will be investigated in non-ambulatory children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MULTIMODAL REHABILITATION GROUP | Active comparator | Behavioral: Multimodal RehabilitationIn addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. |
| TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP | Active comparator | Behavioral: Multimodal Rehabilitation, Device: Transcutaneous diaphragmatic electrical stimulation (TDES)In addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition, patients in this group will receive transcutaneous diaphragmatic electrical stimulation (TDES) twice weekly for 30 minutes per session over a 6-week period. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with Cerebral Palsy (GMFCS Level IV-V)
- Aged 5-18 years
Key exclusion criteria (2 listed)
- Clinically unstable condition,
- Tracheostomy, home-based non-invasive mechanical ventilation (CPAP/BIPAP), continuous oxygen therapy
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 |
|---|---|---|
| Multimodal RehabilitationConventional exercises and electrical stimulation to the lower extremity muscles 5 days per week for 6 weeks, in addition to twice-weekly sessions of robotic rehabilitation, occupational therapy, hydrotherapy, and pulmonary rehabilitation program. | Behavioural | MULTIMODAL REHABILITATION GROUP, TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP |
| Transcutaneous diaphragmatic electrical stimulation (TDES)TDES twice a week for 6 weeks | Device | TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP |
Primary outcome
Diaphragm Function
Time frame: 6 weeks
Using ultrasound, the diaphragm thickness (mm) and the diaphragm thickening fraction (TF %) will be measured and evaluated. During the measurements, children will be positioned in the semi-Fowler's position (30-45°) or, in appropriate cases, in the supine position, and the measurements will be taken from the right hemidiaphragm. In the ultrasound examination, a high-frequency linear probe (8-10 MHz) will be advanced along the midclavicular line toward the midpoint of the anterior axillary line and positioned at the junction between the seventh and eighth costal cartilages. The thickness of the diaphragm, which appears hyperechoic on the outer surface and hypoechoic on the inner surface, will be measured at the end of inspiration and expiration. Children will not be asked to exert maximum effort during the measurement. The thickness of the diaphragm muscle will be measured at the end of expiration (Texp) and the end of inspiration (Tinsp). TF (%) = (Tinsp - Texp) / Texp × 100
1 secondary outcome
Head-Neck Control and Sitting Balance
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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.
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?
A study testing Multimodal Rehabilitation and Transcutaneous diaphragmatic electrical stimulation (TDES) in people with Cerebral Palsy, run by Ankara Etlik City Hospital 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diaphragm Function (time frame: 6 weeks). 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 3 Jun 2026; AzTrials last refreshed its copy on 4 Nov 2026.