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| ID | Type | Description | Link |
|---|---|---|---|
| YOKTEZ-820221 | Other Identifier | YÖK Tez Merkezi |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory Electrical Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VEYSEL MRV VEYSEL, PhD | Harran University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University, Faculty of Health Sciences | Istanbul | 34864 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| 16780624 | Result | 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. | |
| 30913943 |
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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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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.
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No masking is used in this study. Because of the nature of the rehabilitation intervention, participants, care providers, and investigators are aware of the treatment being delivered.
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| Result |
| Alhusaini 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. |
| 12088304 | Result | Dali 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. |
| 41367605 | Result | de 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. |
| 31649770 | Result | Sah 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. |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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