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

NCT04546035 | Completed

• 1 other identifier: LB.02/2.2/443/2020
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spasticity, Muscle; Cerebral Palsy; Child; Spastic

Keywords

Spasticity; Cerebral Palsy; Children; ESWT; Pulses

Outcome Measures

Primary Outcomes (4)

• Baseline Spasticity of Hamstring

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

  Pre-ESWT

• Spasticity of Hamstring immediately post-ESWT

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

  Immediately post-ESWT

• Spasticity of Hamstring 2 weeks post-ESWT

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

  2 weeks post-ESWT

• Spasticity of Hamstring 4 weeks post-ESWT

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

  4 weeks post-ESWT

Study Arms (4)

500 pulses

EXPERIMENTAL

In this group, patients received one single rESWT session consisting of 500 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.

Device: radial Extracorporeal Shockwave Therapy

1,000 pulses

EXPERIMENTAL

In this group, patients received one single rESWT session consisting of 1,000 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.

Device: radial Extracorporeal Shockwave Therapy

1,500 pulses

EXPERIMENTAL

In this group, patients received one single rESWT session consisting of 1,500 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.

Device: radial Extracorporeal Shockwave Therapy

2,000 pulses

EXPERIMENTAL

In this group, patients received one single rESWT session consisting of 2,000 pulses on hamstring muscle with energy flux density at 0.1 mJ/mm2, repetition frequency was at 4 Hz, and a pressure of 1.5 bars.

Device: radial Extracorporeal Shockwave Therapy

Interventions

radial Extracorporeal Shockwave Therapy DEVICE

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

Also known as: rESWT

1,000 pulses; 1,500 pulses; 2,000 pulses; 500 pulses

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rizky Kusuma Wardhani: lead

Study Sites (1)

Universitas Indonesia Fakultas Kedokteran

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Muscle Spasticity; Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants (including parents of patients), physiatrists who conducted ESWT and physiatrists who examined the patients' ASAS score are all blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Physiatrist, Consultant in PM&R Department

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 11, 2020
• Study Start: January 17, 2020
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

ID (1)