Spastic Cerebral Palsy (sCP)NCT07491341
Biomechanical and Functional Effects of Adding Sensory-Threshold Electrical Stimulation to Neurodevelopmental Therapy in Children With Spastic Cerebral Palsy: A Single-Arm Repeated-Measures Study
A study testing Sensory Electrical Stimulation in people with Spastic Cerebral Palsy (sCP), run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether adding sensory-level electrical stimulation to an ongoing neurodevelopmental treatment program is associated with changes in ankle mobility, spasticity-related measures, muscle mechanical properties, and functional performance in children with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Sensory Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2020to 28 May 2021
- Phase
- Interventional
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 15 years
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) level I or II
- Ability to understand simple verbal instructions
- Parent or legal guardian able and willing to provide informed consent
Who cannot join
- Clinically relevant sensory deficits that could affect stimulation perception or outcome assessments
- Uncontrolled epileptic seizures
- Severe perceptual or cognitive problems preventing cooperation
- Significant visual or hearing impairment
- GMFCS level III or higher
- Botulinum toxin injection or orthopedic surgery within the previous 6 months
- Fixed ankle contracture or severe musculoskeletal deformity limiting range of motion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Health Sciences
Istanbul, 34864
About this study
Official title: The Effect of Subthreshold Electrical Stimulation on Spasticity and Functionality in Patients With Spastic Cerebral Palsy
This study investigates whether adding sensory-level electrical stimulation to an ongoing neurodevelopmental treatment program is associated with changes in ankle mobility, spasticity-related measures, muscle mechanical properties, and functional performance in children with spastic cerebral palsy. Children complete a 12-week rehabilitation program and are assessed at baseline, after 6 weeks of neurodevelopmental treatment alone, and after an additional 6 weeks during which sensory-level electrical stimulation is added to the ongoing treatment. The study aims to determine the feasibility of this combined approach and to explore whether favorable changes occur over time in range of motion and functional outcomes.
Read the detailed description
This study is a single-arm, sequential, repeated-measures investigation conducted in children with spastic cerebral palsy. The purpose is to examine biomechanical and functional changes associated with adding sensory-level electrical stimulation to an individualized neurodevelopmental treatment program.
All participants complete a 12-week rehabilitation program with assessments at three time points: baseline (week 0), after Phase 1 (week 6), and after Phase 2 (week 12). During Phase 1, participants receive individualized neurodevelopmental treatment as routine care, 2 days per week for 60 minutes per session. During Phase 2, sensory-level electrical stimulation is added as an adjunct to the ongoing neurodevelopmental treatment and is delivered 3 times per week for 30 minutes per session. Sensory-level stimulation is applied without eliciting visible muscle contraction and is intended to increase sensory afferent input.
The primary outcome is ankle dorsiflexion range of motion. Secondary outcomes include inversion and eversion range of motion, spasticity measures, muscle mechanical properties, and functional outcomes including mobility and independence in daily activities. Assessments are performed at all three study visits to evaluate change over time across the intervention phases.
The study is designed to explore feasibility and preliminary clinical change patterns associated with this combined rehabilitation approach. Because the study does not include a concurrent control group, the findings are intended to provide preliminary evidence to inform future randomized controlled trials.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Sensory Electrical Stimulation
- Keywords
- Sensory Electrical Stimulation, Spastic Cerebral Palsy, Spasticity, Functional Mobility, Ankle Range of Motion
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Electrical StimulationDevice
Also called Sensory-Level Electrical Stimulation
Sensory-level electrical stimulation was applied as an adjunct to ongoing neurodevelopmental treatment during the second phase of the study. Stimulation was delivered 3 times per week for 30 minutes per session without producing visible muscle contraction. The intervention was intended to increase sensory afferent input in children with spastic cerebral palsy.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Electrical Stimulation Plus Neurodevelopmental Treatment | Experimental | All participants received neurodevelopmental treatment during the first phase of the study and then continued with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes were assessed at baseline, after 6 weeks of neurodevelopmental treatment, and after 6 additional weeks of combined treatment. Receives: Device: Sensory Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Dorsiflexion Range of Motion
Ankle dorsiflexion range of motion will be measured to evaluate change across the study intervention phases in children with spastic cerebral palsy.
Measured: Baseline, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start9 Nov 2020
- Primary completion12 Feb 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral Palsy (sCP)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, sequential repeated-measures interventional study. All participants receive neurodevelopmental treatment during the first phase and then continue with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes are assessed at baseline, after the first phase, and after the second phase.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Akduman, Harran University
- Investigators
- VEYSEL MRV VEYSEL, PhD, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491341
- Sponsor's protocol ID
- MU-SBF-2019-131
- Other IDs
- YOKTEZ-820221
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared with other researchers because the study did not include a prespecified data-sharing plan and participant-level data are subject to privacy and confidentiality protections.
Publications
Satheeskumar D, Dhaneshkumar K, Rajasenthil K. Comparative study to identify the effects of transcutaneous electrical nerve stimulation combined with sensorimotor task oriented training to improve the hand function in hemiplegic cerebral palsy children. J Clin Diagnostic Res. (2018) 12(1):YC17-21. 10.7860/JCDR/2018/27015.11092
Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. doi: 10.1017/S0012162206001186.
PubMed 16780624Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.
PubMed 30913943Dali Ci, Hansen FJ, Pedersen SA, Skov L, Hilden J, Bjornskov I, Strandberg C, Christensen J, Haugsted U, Herbst G, Lyskjaer U. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial. Dev Med Child Neurol. 2002 Jun;44(6):364-9. doi: 10.1017/s0012162201002237.
PubMed 12088304de Araujo C, Gschaidmeier A, von Gunten M, Grunt S. Sensory-level electrical stimulation in children with cerebral palsy: a scoping review of current applications and outcomes. Front Pediatr. 2025 Nov 24;13:1644547. doi: 10.3389/fped.2025.1644547. eCollection 2025.
PubMed 41367605Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.
PubMed 31649770
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subthreshold Electrical Stimulation on Spasticity and Functionality in Patients With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07491341
- Acronym / sponsor ID
- MU-SBF-2019-131
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Sensory Electrical Stimulation, Spastic Cerebral Palsy, Spasticity, Functional Mobility, Ankle Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 24 Mar 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.
This study investigates whether adding sensory-level electrical stimulation to an ongoing neurodevelopmental treatment program is associated with changes in ankle mobility, spasticity-related measures, muscle mechanical properties, and functional performance in children with spastic cerebral palsy. Children complete a 12-week rehabilitation program and are assessed at baseline, after 6 weeks of neurodevelopmental treatment alone, and after an additional 6 weeks during which sensory-level electrical stimulation is added to the ongoing treatment. The study aims to determine the feasibility of this combined approach and to explore whether favorable changes occur over time in range of motion and functional outcomes.
Detailed description
This study is a single-arm, sequential, repeated-measures investigation conducted in children with spastic cerebral palsy. The purpose is to examine biomechanical and functional changes associated with adding sensory-level electrical stimulation to an individualized neurodevelopmental treatment program.
All participants complete a 12-week rehabilitation program with assessments at three time points: baseline (week 0), after Phase 1 (week 6), and after Phase 2 (week 12). During Phase 1, participants receive individualized neurodevelopmental treatment as routine care, 2 days per week for 60 minutes per session. During Phase 2, sensory-level electrical stimulation is added as an adjunct to the ongoing neurodevelopmental treatment and is delivered 3 times per week for 30 minutes per session. Sensory-level stimulation is applied without eliciting visible muscle contraction and is intended to increase sensory afferent input.
The primary outcome is ankle dorsiflexion range of motion. Secondary outcomes include inversion and eversion range of motion, spasticity measures, muscle mechanical properties, and functional outcomes including mobility and independence in daily activities. Assessments are performed at all three study visits to evaluate change over time across the intervention phases.
The study is designed to explore feasibility and preliminary clinical change patterns associated with this combined rehabilitation approach. Because the study does not include a concurrent control group, the findings are intended to provide preliminary evidence to inform future randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, sequential repeated-measures interventional study. All participants receive neurodevelopmental treatment during the first phase and then continue with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes are assessed at baseline, after the first phase, and after the second phase.
| Arm | Type | Receives |
|---|---|---|
| Sensory Electrical Stimulation Plus Neurodevelopmental Treatment | Experimental | Device: Sensory Electrical StimulationAll participants received neurodevelopmental treatment during the first phase of the study and then continued with neurodevelopmental treatment combined with sensory-level electrical stimulation during the second phase. Outcomes were assessed at baseline, after 6 weeks of neurodevelopmental treatment, and after 6 additional weeks of combined treatment. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5 to 15 years
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) level I or II
- Ability to understand simple verbal instructions
- Parent or legal guardian able and willing to provide informed consent
Key exclusion criteria (7 listed)
- Clinically relevant sensory deficits that could affect stimulation perception or outcome assessments
- Uncontrolled epileptic seizures
- Severe perceptual or cognitive problems preventing cooperation
- Significant visual or hearing impairment
- GMFCS level III or higher
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 |
|---|---|---|
| Sensory Electrical StimulationAlso: Sensory-Level Electrical StimulationSensory-level electrical stimulation was applied as an adjunct to ongoing neurodevelopmental treatment during the second phase of the study. Stimulation was delivered 3 times per week for 30 minutes per session without producing visible muscle contraction. The intervention was intended to increase sensory afferent input in children with spastic cerebral palsy. | Device | Sensory Electrical Stimulation Plus Neurodevelopmental Treatment |
Primary outcome
Ankle Dorsiflexion Range of Motion
Time frame: Baseline, Week 6, and Week 12
Ankle dorsiflexion range of motion will be measured to evaluate change across the study intervention phases in children with spastic cerebral palsy.
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 24 Mar 2026.
- Results publicationSatheeskumar D, Dhaneshkumar K, Rajasenthil K. Comparative study to identify the effects of transcutaneous electrical nerve stimulation combined with sensorimotor task oriented training to improve the hand function in hemiplegic cerebral palsy children. J Clin Diagnostic Res. (2018) 12(1):YC17-21. 10.7860/JCDR/2018/27015.11092
- Results publication: PubMed 16780624Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. doi: 10.1017/S0012162206001186.
- Results publication: PubMed 30913943Alhusaini AA, Fallatah S, Melam GR, Buragadda S. Efficacy of transcutaneous electrical nerve stimulation combined with therapeutic exercise on hand function in children with hemiplegic cerebral palsy. Somatosens Mot Res. 2019 Mar;36(1):49-55. doi: 10.1080/08990220.2019.1584555. Epub 2019 Mar 26.
- Results publication: PubMed 12088304Dali Ci, Hansen FJ, Pedersen SA, Skov L, Hilden J, Bjornskov I, Strandberg C, Christensen J, Haugsted U, Herbst G, Lyskjaer U. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial. Dev Med Child Neurol. 2002 Jun;44(6):364-9. doi: 10.1017/s0012162201002237.
- Results publication: PubMed 41367605de Araujo C, Gschaidmeier A, von Gunten M, Grunt S. Sensory-level electrical stimulation in children with cerebral palsy: a scoping review of current applications and outcomes. Front Pediatr. 2025 Nov 24;13:1644547. doi: 10.3389/fped.2025.1644547. eCollection 2025.
- Results publication: PubMed 31649770Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be shared with other researchers because the study did not include a prespecified data-sharing plan and participant-level data are subject to privacy and confidentiality protections.
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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.
VEYSEL MRV VEYSEL, PhD principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Electrical Stimulation in people with Spastic Cerebral Palsy (sCP), run by Harran University 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 24 Mar 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?
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?
Ankle Dorsiflexion Range of Motion (time frame: Baseline, Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07491341, which also lists 6 linked publications.
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 24 Mar 2026.