Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy

NCT04574622 | Completed

• 1 other identifier: KET885/UN2F1/ETIK/PPM0002/2019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity, defined as a velocity dependent increase in tonic stretch reflexes, is one of the most prominent motor problems that occur in patients with cerebral palsy (CP). This causes difficulty in achieving balance, mobility, and an upright stance. CP is a group of permanent disorders that affect the development of movement and posture caused by a non-progressive damage to the brain. Because CP occurs in 2-3 of 1000 individuals, it is one of the most common causes of severe physical disability in children. Mismanagement of spasticity can lead to contracture which is extremely difficult to treat and may result in severe functional disabilities. The current management of spasticity in CP includes physical therapy (i.e. passive stretching), oral medication, botulinum toxin injection, and surgery. Botulinum toxin injection has been proven to effectively reduce spasticity yet many patients are unable to get access to this treatment due to its high cost. Moreover, Botulinum toxin injection is currently not covered by the public health insurance of Indonesia. Therefore, other modalities which are more affordable and are non-invasive therapies should be considered as a treatment option for spasticity. Radial Extracorporeal Shockwave Therapy (rESWT) has been utilized in the medical practice for the treatment of several musculoskeletal disorders such as chronic tendinopathies and spasticity. It is hypothesized that ESWT has two main effects which include a direct effect from mechanical forces at the treatment point and an indirect effect from cavitation. Even though rESWT has less penetration capacity over the focused Extracorporeal Shockwave Therapy (fESWT), rESWT is still believed to be more superior to fESWT because it requires less precise focusing, is less painful, and costs less. These also make rESWT the more appropriate choice for children with CP. Many studies have proven the efficacy of ESWT in reducing spasticity in spastic CP patients with significantly long lasting effects. Despite promising results, there still has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One of the critical parameters needed to be determined is the frequency of treatment. Therefore, the objective of this study is to understand whether the reduction in gastrocnemius stiffness in children with spastic CP is influenced by the frequency of ESWT sessions.

Conditions

Spasticity, Muscle; Cerebral Palsy; Child; Spastic

Keywords

Spasticity; Cerebral Palsy; Children; ESWT; Frequency

Outcome Measures

Primary Outcomes (9)

• Baseline Spasticity of Gastrocnemius

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

  pre-ESWT

• Spasticity of Gastrocnemius after first ESWT session

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

  After first ESWT session (Week 1)

• Spasticity of Gastrocnemius after second ESWT session

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

  After second ESWT session (Week 2)

• Spasticity of Gastrocnemius after third ESWT session

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

  After third ESWT session (Week 3)

• Spasticity of Gastrocnemius after fourth ESWT session

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

  After fourth ESWT session (Week 4)

• Spasticity of Gastrocnemius after fifth ESWT session

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

  After fifth ESWT session (Week 5)

• Spasticity of Gastrocnemius four weeks after fifth (last) ESWT session

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

  Four weeks after fifth (last) ESWT session (Week 9)

• Spasticity of Gastrocnemius eight weeks after fifth (last) ESWT session

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

  Eight weeks after fifth (last) ESWT session (Week 13)

• Spasticity of Gastrocnemius twelve weeks after fifth (last) ESWT session

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

  Twelve weeks after fifth (last) ESWT session (Week 17)

Study Arms (2)

Five true ESWT sessions

EXPERIMENTAL

A total of five sessions (1x/week) were conducted. A total of 1,500 pulses were delivered to each gastrocnemius muscle. 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.

Device: radial Extracorporeal Shockwave Therapy

Three true ESWT sessions and two sham ESWT sessions

EXPERIMENTAL

A total of three true ESWT (week 1, 3 and 5) and two sham ESWTs in (week 2 and 4) were conducted. For true ESWT sessions, a total of 1,500 pulses were delivered to each gastrocnemius muscle. 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 sham ESWT sessions, a total of 1,500 pulses were delivered to each gastrocnemius muscle with a 1 cm gap between between the probe and subject's skin. 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.

Device: radial Extracorporeal Shockwave Therapy

Interventions

radial Extracorporeal Shockwave Therapy DEVICE

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

Five true ESWT sessions; Three true ESWT sessions and two sham ESWT sessions

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 gastrocnemius 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 gastrocnemius

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 Officials

• Rizky K Wardhani, M.D., Physiatrist

  Universitas Indonesia Fakultas Kedokteran

  PRINCIPAL INVESTIGATOR

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: September 22, 2020
• First Posted: October 5, 2020
• Study Start: January 17, 2020
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

ID (1)