Spasticity, MuscleNCT04574622
Effect of Session Frequency of rESWT on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy
A study testing radial Extracorporeal Shockwave Therapy in people with Spasticity, Muscle and Cerebral Palsy, run by Rizky Kusuma Wardhani at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Spasticity, Muscle, Cerebral Palsy, Child; Spastic
- What is being tested?
- radial Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Jan 2020to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 6 months or less since the last botulinum injection on hamstring
- surgical operation on lower limb within the last 12 months
- severe contracture on gastrocnemius
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia Fakultas Kedokteran
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effect of Session Frequency of Radial Extracorporeal Shock Wave Therapy (rESWT) on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy: A Double-Blinded, Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
This study was designed as a double-blinded and randomized controlled trial.
Pediatric CP patients from the Department of Physical Medicine and Rehabilitation at Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM) are involved in this research. Participants were selected using the inclusion criteria as follow: 1) children with spastic CP who are 5 - 18 years old, 2) one or two gastrocnemius muscle with an Australian Spasticity Assessment Scale (ASAS) of two or more, 3) at least 6 months since the last botulinum injection on gastrocnemius, 4) no surgical operation on lower limb within the last 12 months, 5) absence of severe contracture on gastrocnemius, and 6) ability of legal caregiver to provide written informed consent.
The spasticity of gastrocnemius was evaluated using ASAS (0: no spasticity to 4: severe spasticity). Data were collected at nine time points: 1) pre-ESWT, 2-6) immediately after each ESWT session, 7) 4 weeks after the last (fifth) ESWT session, 8) 8 weeks after the last (fifth) ESWT session, and 9) 12 weeks after the last (fifth) ESWT session. All patients were examined by the same physiatrist who was blinded to the protocol (i.e. not informed about the study and the group allocation) throughout the whole study.
The investigators used a BTL-6000 SWT Topline (BTL, Czech Republic) to apply rESWT on gastrocnemius muscles. For the procedures, a 1.2 cm probe was used. 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 double-blinded treatment, 28 different spastic gastrocnemius muscles from 14 CP patients were allocated into two groups. Both groups had a true or sham ESWT for five consecutive weekly treatments. Group I received five true ESWT sessions. Group II received three true ESWT in session 1, 3 and 5 and two sham ESWTs in session 2 and 4. 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 after each ESWT, 4 weeks after last (fifth) ESWT, 8 weeks after last (fifth) ESWT and 12 weeks after last (fifth) ESWT; followed by post-hoc Wilcoxon signed-ranked test. Inter-group differences in ASAS reduction were analyzed using Mann-Whitney U- test. Statistical analysis was conducted using SPSS ver. 23.0 (IBM Corporation, Armonk, NY, USA). The level of significance was set at <0.05.
- Conditions
- Spasticity, Muscle, Cerebral Palsy, Child; Spastic
- Being tested
- radial Extracorporeal Shockwave Therapy
- Keywords
- Spasticity, Cerebral Palsy, Children, ESWT, Frequency
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial Extracorporeal Shockwave TherapyDevice
rESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: radial Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Spasticity of Gastrocnemius
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Twelve weeks after fifth (last) ESWT session (Week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start17 Jan 2020
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rizky Kusuma Wardhani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rizky Kusuma Wardhani, Universitas Indonesia
- Investigators
- Rizky K Wardhani, M.D., Physiatrist, Principal investigator, Universitas Indonesia Fakultas Kedokteran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574622
- Sponsor's protocol ID
- KET885/UN2F1/ETIK/PPM0002/2019
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Session Frequency of Radial Extracorporeal Shock Wave Therapy (rESWT) on Gastrocnemius Muscle Spasticity in Children With Spastic Type Cerebral Palsy: A Double-Blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04574622
- Acronym / sponsor ID
- KET885/UN2F1/ETIK/PPM0002/2019
- Conditions
- Spasticity, Muscle, Cerebral Palsy, Child; Spastic
- Keywords
- Spasticity, Cerebral Palsy, Children, ESWT, Frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rizky Kusuma WardhaniUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed as a double-blinded and randomized controlled trial.
Pediatric CP patients from the Department of Physical Medicine and Rehabilitation at Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM) are involved in this research. Participants were selected using the inclusion criteria as follow: 1) children with spastic CP who are 5 - 18 years old, 2) one or two gastrocnemius muscle with an Australian Spasticity Assessment Scale (ASAS) of two or more, 3) at least 6 months since the last botulinum injection on gastrocnemius, 4) no surgical operation on lower limb within the last 12 months, 5) absence of severe contracture on gastrocnemius, and 6) ability of legal caregiver to provide written informed consent.
The spasticity of gastrocnemius was evaluated using ASAS (0: no spasticity to 4: severe spasticity). Data were collected at nine time points: 1) pre-ESWT, 2-6) immediately after each ESWT session, 7) 4 weeks after the last (fifth) ESWT session, 8) 8 weeks after the last (fifth) ESWT session, and 9) 12 weeks after the last (fifth) ESWT session. All patients were examined by the same physiatrist who was blinded to the protocol (i.e. not informed about the study and the group allocation) throughout the whole study.
The investigators used a BTL-6000 SWT Topline (BTL, Czech Republic) to apply rESWT on gastrocnemius muscles. For the procedures, a 1.2 cm probe was used. 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 double-blinded treatment, 28 different spastic gastrocnemius muscles from 14 CP patients were allocated into two groups. Both groups had a true or sham ESWT for five consecutive weekly treatments. Group I received five true ESWT sessions. Group II received three true ESWT in session 1, 3 and 5 and two sham ESWTs in session 2 and 4. 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 after each ESWT, 4 weeks after last (fifth) ESWT, 8 weeks after last (fifth) ESWT and 12 weeks after last (fifth) ESWT; followed by post-hoc Wilcoxon signed-ranked test. Inter-group differences in ASAS reduction were analyzed using Mann-Whitney U- test. Statistical analysis was conducted using SPSS ver. 23.0 (IBM Corporation, Armonk, NY, USA). The level of significance was set at <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Five true ESWT sessions | Experimental | Device: radial Extracorporeal Shockwave TherapyA 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. |
| Three true ESWT sessions and two sham ESWT sessions | Experimental | Device: radial Extracorporeal Shockwave TherapyA 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 6 months or less since the last botulinum injection on hamstring
- surgical operation on lower limb within the last 12 months
- severe contracture on gastrocnemius
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radial Extracorporeal Shockwave TherapyrESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required. | Device | Five true ESWT sessions, Three true ESWT sessions and two sham ESWT sessions |
Primary outcome
Baseline Spasticity of Gastrocnemius
Time frame: pre-ESWT
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius after first ESWT session
Time frame: After first ESWT session (Week 1)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius after second ESWT session
Time frame: After second ESWT session (Week 2)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius after third ESWT session
Time frame: After third ESWT session (Week 3)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius after fourth ESWT session
Time frame: After fourth ESWT session (Week 4)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius after fifth ESWT session
Time frame: After fifth ESWT session (Week 5)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius four weeks after fifth (last) ESWT session
Time frame: Four weeks after fifth (last) ESWT session (Week 9)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius eight weeks after fifth (last) ESWT session
Time frame: Eight weeks after fifth (last) ESWT session (Week 13)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Spasticity of Gastrocnemius twelve weeks after fifth (last) ESWT session
Time frame: Twelve weeks after fifth (last) ESWT session (Week 17)
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rizky K Wardhani, M.D., Physiatrist principal investigator
Universitas Indonesia Fakultas Kedokteran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial Extracorporeal Shockwave Therapy in people with Spasticity, Muscle and Cerebral Palsy, run by Rizky Kusuma Wardhani at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Spasticity of Gastrocnemius (time frame: pre-ESWT). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.