Skip to main content
OpenTrials
Completed

NCT Number: NCT04546035

Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy

Cerebral palsy (CP) is a group of permanent disorders affecting movement and postural development that are caused by non-progressive disruptions of the brain, usually occurring during fetal period or infancy. It is commonly accompanied with sensory disorders and learning disability. In 2016, more than 17 million people are affected by CP with a prevalence of 1.5 to 2.5 per 1,000 live births. CP remains to be the most common cause of severe physical disability in children. The Centres for Disease Control and Prevention (CDC) estimated an economic cost of US$4.1 million per CP patient that comprises of medical services, special education and productivity loss.

Current management of spasticity involves physical manipulation such as passive stretching and splinting, sometimes combined with oral pharmacologic treatment, intrathecal baclofen therapy and botulinum toxin injection. At times, surgical procedures such as Surgical Dorsal Rhizotomy (SDR) can also be considered. Botulinum toxin injection has been shown to reduce spasticity for up to 6 months, however, the cost of the procedure remains to be an issue in developing countries like Indonesia. Therefore, other modality such as a non-invasive therapy should be considered as an alternative treatment for spasticity.

Radial Extracorporeal Shockwave Therapy (rESWT) is a non-invasive treatment that has been shown to effectively improve spasticity in patients with spastic motor type CP, despite unclear underlying mechanism. According to International Society for Medical Shockwave Treatment (ISMST), there has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One crucial physical parameter needed to be determined is the number of pulse required to efficiently reduce spasticity. The number of pulse directly affects the duration of ESWT per session (the higher the number of pulse given, the longer the therapy session). This may be a concern for spastic motor type CP due to accompanying sensory and learning disability. Therefore, the objective of this study was to understand whether the reduction in hamstring stiffness in children with spastic CP could be influenced by the number of pulse in a single ESWT session.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spasticity, Muscle Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Child; Spastic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia Fakultas Kedokteran

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

This study was designed as a double-blinded and randomized controlled trial.

Children with spastic CP from the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM) participated in the study. The patients were randomly allocated to four groups: 500 pulses, 1,000 pulses, 1,500 pulses, and 2,000 pulses. All groups undergo routine rehabilitation, including physiotherapy. Ethical approval was obtained from the Ethical Committee of Faculty of Medicine, University of Indonesia - RSCM.

Spasticity of hamstring was evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity). Evaluations were done at four time points: 1) pre-ESWT, 2) immediately post-ESWT, 3) 2 weeks post-ESWT, and 4) 4 weeks post-ESWT. All patients were examined by the same physiatrist with the patient lying on supine position on the stretcher.

BTL-6000 SWT Topline (BTL, Czech Republic) was used to apply rESWT on hamstring muscles, with the subject lying on prone position. The energy flux density was constant at 0.1 mJ/mm2 and the repetition frequency was at 4 Hz, with a pressure of 1.5 bars. For double-blinded treatment, spastic hamstring muscles from CP patients were allocated into four groups - each group receiving a varying total number of pulses (group I: 500 pulses, group II: 1,000 pulses, group III: 1.500 pulses, and group IV: 2,000 pulses). No anesthesia was given. Adverse events were closely monitored during and after therapy.

Intra-group changes in ASAS were evaluated with Friedman analysis of variance from baseline immediately post ESWT, 2 weeks post ESWT, and 4 weeks post ESWT; followed by post-hoc Wilcoxon signed-ranked test. Inter-group differences in ASAS reduction were analyzed using Kruskal Wallis test. Statistical analysis was conducted using SPSS ver. 23.0 (IBM Corporation, Armonk, NY, USA). The level of significance was set at <0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with spastic CP aged 5 to 18 years old
  • at least one hamstring with an Australian Spasticity Assessment Scale (ASAS) of 2 or more
  • ability of legal respondent to give written informed consent

Exclusion criteria

  • 6 months or less since the last botulinum injection on hamstring
  • surgical operation on lower limb within the last 12 months
  • severe contracture on hamstring

Treatment and study plan

Radial Extracorporeal Shockwave Therapy

Device

rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.

Other names: rESWT

Primary outcomes

  1. Baseline Spasticity of Hamstring

    Time frame: Pre-ESWT

    Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)

  2. Spasticity of Hamstring immediately post-ESWT

    Time frame: Immediately post-ESWT

    Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)

  3. Spasticity of Hamstring 2 weeks post-ESWT

    Time frame: 2 weeks post-ESWT

    Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)

  4. Spasticity of Hamstring 4 weeks post-ESWT

    Time frame: 4 weeks post-ESWT

    Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)

Sponsors and collaborators

Lead sponsor

Rizky Kusuma Wardhani

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2020
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.