Spasticity, MuscleNCT04546035
Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With 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
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. 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
- 13 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Jan 2020to 26 Mar 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 hamstring 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 hamstring
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia Fakultas Kedokteran
Jakarta Pusat, DKI Jakarta, 10430
About this study
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.
Read the detailed description
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.
- Conditions
- Spasticity, Muscle, Cerebral Palsy, Child; Spastic
- Being tested
- radial Extracorporeal Shockwave Therapy
- Keywords
- Spasticity, Cerebral Palsy, Children, ESWT, Pulses
- 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
Also called rESWT
rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. 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 Hamstring
Evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 weeks post-ESWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start17 Jan 2020
- Primary completion26 Mar 2020
- Study completion26 Mar 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
- 13 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546035
- Sponsor's protocol ID
- LB.02/2.2/443/2020
- Status last verified
- Sep 2020
- First submitted
- 24 Aug 2020
- Last updated
- 11 Sep 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 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04546035
- Acronym / sponsor ID
- LB.02/2.2/443/2020
- Conditions
- Spasticity, Muscle, Cerebral Palsy, Child; Spastic
- Keywords
- Spasticity, Cerebral Palsy, Children, ESWT, Pulses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rizky Kusuma WardhaniUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 11 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 500 pulses | Experimental | Device: radial Extracorporeal Shockwave TherapyIn 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. |
| 1,000 pulses | Experimental | Device: radial Extracorporeal Shockwave TherapyIn 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. |
| 1,500 pulses | Experimental | Device: radial Extracorporeal Shockwave TherapyIn 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. |
| 2,000 pulses | Experimental | Device: radial Extracorporeal Shockwave TherapyIn 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. |
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 hamstring 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 hamstring
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 TherapyAlso: rESWTrESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required. | Device | 1,000 pulses, 1,500 pulses, 2,000 pulses, 500 pulses |
Primary outcome
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)
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)
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)
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)
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 11 Sep 2020.
Related trials for Spasticity, Muscle
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
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 11 Sep 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 Hamstring (time frame: Pre-ESWT). The study lists 4 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 11 Sep 2020.