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The effect of combined transcranial pulsed current stimulation and transcutaneous electrical nerve stimulation on lower limb spasticity in children with spastic cerebral palsy: a randomized and controlled clinical study

The effect of combined transcranial pulsed current stimulation and transcutaneous electrical nerve stimulation on lower limb spasticity in children with spastic cerebral palsy: a randomized and controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020283
Enrollment
Unknown
Registered
2018-12-22
Start date
2018-06-04
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Cerebral Palsy

Interventions

Experimental group:combined tPCS and TENS stimulation + physiotherapy

Sponsors

Nanhai Maternity and Children's Hospital Affliated To Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of spastic cerebral palsy according to diagnostic criteria of CP found in international guidelines; 2. Aged between 2–12 years of age;no restriction on male or female; 3. GMFCS classification levels of III, IV, or V; 4. Lower limb muscle tone in Grades I–IV in accordance to the Modified Ashworth Scale (MAS); 5. Intelligence quotient score > 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales; 6. No severe psychosocial or behavioral problems, such as high aggression or risk of self-harm; 7. No severe cardiopulmonary diseases; 8. Voluntary participation and informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Initiation of oral anti-spasm medication, botulinum toxin injections, or surgery performed less than 90 days before enrollment; 2. Severe visual or auditory impairment; 3. Uncontrollable epilepsy defined as the occurrence of seizures despite the use of at least one antiepileptic drug at an adequate dose; 4. History of craniotomy or skull defects; severe neurological disorders, such as brain tumors, intracranial infection/ lesions, metal implants in the skull; 5. Severe orthopedic deformities; and immune diseases and skin infections. Drop-out criteria: 1.Subjects who voluntarily terminated treatment during the course of treatment; 2.subjects who did not receive treatment according to plan, either due to poor compliance or non-cooperation; 3.subjects who were not suitable to continue the trial due to serious adverse reactions or appearance of other accompanying diseases.

Design outcomes

Primary

MeasureTime frame
change in passive muscle stretch of left and right adductors, hamstring and gastrocnemius;

Secondary

MeasureTime frame
change in R1 (fast stretch), R2 (passive range of motion) and R2-R1 (Dynamic component of spasticity) of left and right hip adductor, knee joints and ankle joints;

Countries

China

Contacts

Public ContactLiu Zhen-Huan

Nanhai Maternity and Children's Hospital Affliated To Guangzhou University of Traditional Chinese Medicine

lzh1958424@163.com+86 13923185885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026