Spastic QuadriplegiaNCT07894003
Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy
A study testing Focused Extracorporeal Shock Wave Therapy and Radial Extracorporeal Shock Wave Therapy in people with Spastic Quadriplegia and Cerebral Palsy (CP), run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Spastic Quadriplegia, Cerebral Palsy (CP), Gastrocnemius Muscle
- What is being tested?
- Focused Extracorporeal Shock Wave Therapy and Radial Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Dec 2025to 14 Sep 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children diagnosed with Spastic Quadriplegic Cerebral Palsy by a pediatrician or pediatric neurologist;
- Modified Ashworth Scale (MAS) score of ≥1 at the gastrocnemius muscle
- No fixed contracture of the affected skeletal muscles;
- Parents or legal guardians who provided written informed consent after receiving education about the fESWT and rESWT procedures and their associated risks.
Who cannot join
- Parents or caregivers who were unable to cooperate during clinical assessments;
- Parents or caregivers who were unwilling to participate in the study;
- Children who were acutely ill at the time of intervention (e.g., with cough, fever, or upper respiratory tract infection);
- Children who had received botulinum toxin type A injection within the past 6 months;
- Children who had undergone lower limb surgery within the past 12 months.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National General Hospital (RSCM)
Jakarta Pusat, DKI Jakarta
About this study
Official title: Comparison of Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy: A Pilot Randomized Control
The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are:
- Does focused ESWT (fESWT) reduce gastrocnemius spasticity more effectively than radial ESWT (rESWT)?
- Are the antispastic effects of fESWT more durable over time compared with rESWT?
Read more
Researchers will compare:
- fESWT group (one session weekly, 4 weeks)
- rESWT group (one session weekly, 4 weeks) to see if fESWT more effective to lower Modified Ashworth Scale (MAS) scores during all assessment time points compared with rESWT.
Participants will:
- Be randomly assigned to either fESWT or rESWT group.
- Receive one treatment session per week for 4 consecutive weeks.
- Undergo MAS score evaluations at: baseline, post-intervention weeks 1-4, and follow-up at 4, 8, and 12 weeks after the final treatment.
Read the detailed description
Dosing parameter is identical in both groups: 1,500 shocks, 2 bar, 6 Hz, medium energy intensity.
- Being tested
- Focused Extracorporeal Shock Wave Therapy, Radial Extracorporeal Shock Wave Therapy
- Keywords
- spastic quadriplegic cerebral palsy, gastrocnemius muscle spasticity, focused ESWT, radial ESWT
- Medical subject headings
- Quadriplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Extracorporeal Shock Wave TherapyDevice
Also called fESWT, focused shockwave therapy
Focused ESWT (fESWT) generates true acoustic shockwaves that converge at a defined focal point within deeper tissue. Dosing parameters: total impulses 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
Radial Extracorporeal Shock Wave TherapyDevice
Also called rESWT, radial shockwave therapy
Radial ESWT (rESWT) uses pneumatic acceleration of a projectile that produces pressure waves diverging from the applicator tip, with maximal energy at the skin surface and progressively decreasing energy with depth. Dosing parameters: 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
| Study group | Role | What they receive |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy | Active comparator | Total impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus.
Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. Receives: Device: Focused Extracorporeal Shock Wave Therapy |
| Radial Extracorporeal Shock Wave Therapy | Active comparator | Total impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus.
Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. Receives: Device: Radial Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Ashworth Scale (MAS) score of the gastrocnemius muscle
The primary outcome was the Modified Ashworth Scale (MAS) score of the gastrocnemius muscle, recorded as an ordinal score on a 6-point scale (0, 1, 1.5, 2, 3, and 4), measuring resistance to passive stretch.
Measured: The primary outcome was evaluated at baseline, post-intervention weeks 1 to 4, and follow-up at 4, 8, and 12 weeks post-final treatment by blinded outcome assessor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start12 Dec 2025
- Primary completion31 Aug 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spastic QuadriplegiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizky Kusuma Wardhani, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rizky K Wardhani, Dr, Principal investigator, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894003
- Sponsor's protocol ID
- RKW-1672
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to the small sample size and privacy considerations for pediatric participants.
Publications
Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
PubMed 27188686Brandenburg JE, Rabatin AE, Driscoll SW. Spasticity Interventions: Decision-Making and Management. Pediatr Clin North Am. 2023 Jun;70(3):483-500. doi: 10.1016/j.pcl.2023.01.005. Epub 2023 Mar 21.
PubMed 37121638Zhang HL, Jin RJ, Guan L, Zhong DL, Li YX, Liu XB, Xiao QW, Xiao XL, Li J. Extracorporeal Shock Wave Therapy on Spasticity After Upper Motor Neuron Injury: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2022 Jul 1;101(7):615-623. doi: 10.1097/PHM.0000000000001977. Epub 2022 Feb 15.
PubMed 35152251Chang MC, Choo YJ, Kwak SG, Nam K, Kim SY, Lee HJ, Kwak S. Effectiveness of Extracorporeal Shockwave Therapy on Controlling Spasticity in Cerebral Palsy Patients: A Meta-Analysis of Timing of Outcome Measurement. Children (Basel). 2023 Feb 9;10(2):332. doi: 10.3390/children10020332.
PubMed 36832460Yang SM, Chen SY, Chen KY, Lai TJ, Lin MT. Efficacy of extracorporeal shock wave therapy for post-stroke spasticity and dose-response analysis: a meta-analysis of randomized controlled trials. Eur J Phys Rehabil Med. 2025 Dec;61(6):787-797. doi: 10.23736/S1973-9087.25.08796-9.
PubMed 41677776Wu YT, Chang CN, Chen YM, Hu GC. Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):518-525. doi: 10.23736/S1973-9087.17.04801-8. Epub 2017 Oct 25.
PubMed 29072044Park DS, Kwon DR, Park GY, Lee MY. Therapeutic Effect of Extracorporeal Shock Wave Therapy According to Treatment Session on Gastrocnemius Muscle Spasticity in Children With Spastic Cerebral Palsy: A Pilot Study. Ann Rehabil Med. 2015 Dec;39(6):914-21. doi: 10.5535/arm.2015.39.6.914. Epub 2015 Dec 29.
PubMed 26798605Duan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
PubMed 36846123Mihai EE, Popescu MN, Iliescu AN, Berteanu M. A systematic review on extracorporeal shock wave therapy and botulinum toxin for spasticity treatment: a comparison on efficacy. Eur J Phys Rehabil Med. 2022 Aug;58(4):565-574. doi: 10.23736/S1973-9087.22.07136-2. Epub 2022 Apr 12.
PubMed 35412036Ozbek IC, Tikiz C. Effectiveness of radial extracorporeal shock wave therapy in post-stroke spasticity patients: Evaluation with shear wave elastography. Turk J Phys Med Rehabil. 2024 Dec 27;71(2):206-215. doi: 10.5606/tftrd.2025.14800. eCollection 2025 Jun.
PubMed 40740180Tur Segura M, Gimeno Esteve F, Biedermann Villagra T, Jimenez Redondo J, Garcia Rodriguez N, Mila Villarroel R. Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: study protocol for a randomized controlled trial. Front Neurol. 2024 Jun 13;15:1402452. doi: 10.3389/fneur.2024.1402452. eCollection 2024.
PubMed 38957349Wardhani RK, Wahyuni LK, Laksmitasari B, Lakmudin A. Effect of total number of pulses of radial extracorporeal shock wave therapy (rESWT) on hamstring muscle spasticity in children with spastic type cerebral palsy: A randomized clinical trial. J Pediatr Rehabil Med. 2022;15(1):159-164. doi: 10.3233/PRM-200796.
PubMed 35275569
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Focused Versus Radial Extracorporeal Shock Wave Therapy on Gastrocnemius Spasticity in Children With Spastic Quadriplegic Cerebral Palsy: A Pilot Randomized Control
- ClinicalTrials.gov ID
- NCT07894003
- Acronym / sponsor ID
- RKW-1672
- Keywords
- spastic quadriplegic cerebral palsy, gastrocnemius muscle spasticity, focused ESWT, radial ESWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 26 Oct 2026 (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.
The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are:
- Does focused ESWT (fESWT) reduce gastrocnemius spasticity more effectively than radial ESWT (rESWT)?
- Are the antispastic effects of fESWT more durable over time compared with rESWT?
Researchers will compare:
- fESWT group (one session weekly, 4 weeks)
- rESWT group (one session weekly, 4 weeks) to see if fESWT more effective to lower Modified Ashworth Scale (MAS) scores during all assessment time points compared with rESWT.
Participants will:
- Be randomly assigned to either fESWT or rESWT group.
- Receive one treatment session per week for 4 consecutive weeks.
- Undergo MAS score evaluations at: baseline, post-intervention weeks 1-4, and follow-up at 4, 8, and 12 weeks after the final treatment.
Detailed description
Dosing parameter is identical in both groups: 1,500 shocks, 2 bar, 6 Hz, medium energy intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Extracorporeal Shock Wave Therapy | Active comparator | Device: Focused Extracorporeal Shock Wave TherapyTotal impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. |
| Radial Extracorporeal Shock Wave Therapy | Active comparator | Device: Radial Extracorporeal Shock Wave TherapyTotal impulses per session: 1,500 shocks. Pressure: 2 bar. Frequency: 6 Hz. Energy intensity: medium. Treatment frequency: once weekly for four consecutive weeks (Weeks 1-4). Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Coupling medium: standard ultrasound gel. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children diagnosed with Spastic Quadriplegic Cerebral Palsy by a pediatrician or pediatric neurologist;
- Modified Ashworth Scale (MAS) score of ≥1 at the gastrocnemius muscle
- No fixed contracture of the affected skeletal muscles;
- Parents or legal guardians who provided written informed consent after receiving education about the fESWT and rESWT procedures and their associated risks.
Key exclusion criteria (5 listed)
- Parents or caregivers who were unable to cooperate during clinical assessments;
- Parents or caregivers who were unwilling to participate in the study;
- Children who were acutely ill at the time of intervention (e.g., with cough, fever, or upper respiratory tract infection);
- Children who had received botulinum toxin type A injection within the past 6 months;
- Children who had undergone lower limb surgery within the past 12 months.
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 |
|---|---|---|
| Focused Extracorporeal Shock Wave TherapyAlso: fESWT, focused shockwave therapyFocused ESWT (fESWT) generates true acoustic shockwaves that converge at a defined focal point within deeper tissue. Dosing parameters: total impulses 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. | Device | Focused Extracorporeal Shock Wave Therapy |
| Radial Extracorporeal Shock Wave TherapyAlso: rESWT, radial shockwave therapyRadial ESWT (rESWT) uses pneumatic acceleration of a projectile that produces pressure waves diverging from the applicator tip, with maximal energy at the skin surface and progressively decreasing energy with depth. Dosing parameters: 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position. | Device | Radial Extracorporeal Shock Wave Therapy |
Primary outcome
The Modified Ashworth Scale (MAS) score of the gastrocnemius muscle
Time frame: The primary outcome was evaluated at baseline, post-intervention weeks 1 to 4, and follow-up at 4, 8, and 12 weeks post-final treatment by blinded outcome assessor.
The primary outcome was the Modified Ashworth Scale (MAS) score of the gastrocnemius muscle, recorded as an ordinal score on a 6-point scale (0, 1, 1.5, 2, 3, and 4), measuring resistance to passive stretch.
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 26 Oct 2026.
- Background: PubMed 27188686Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
- Background: PubMed 37121638Brandenburg JE, Rabatin AE, Driscoll SW. Spasticity Interventions: Decision-Making and Management. Pediatr Clin North Am. 2023 Jun;70(3):483-500. doi: 10.1016/j.pcl.2023.01.005. Epub 2023 Mar 21.
- Background: PubMed 35152251Zhang HL, Jin RJ, Guan L, Zhong DL, Li YX, Liu XB, Xiao QW, Xiao XL, Li J. Extracorporeal Shock Wave Therapy on Spasticity After Upper Motor Neuron Injury: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2022 Jul 1;101(7):615-623. doi: 10.1097/PHM.0000000000001977. Epub 2022 Feb 15.
- Background: PubMed 36832460Chang MC, Choo YJ, Kwak SG, Nam K, Kim SY, Lee HJ, Kwak S. Effectiveness of Extracorporeal Shockwave Therapy on Controlling Spasticity in Cerebral Palsy Patients: A Meta-Analysis of Timing of Outcome Measurement. Children (Basel). 2023 Feb 9;10(2):332. doi: 10.3390/children10020332.
- Background: PubMed 41677776Yang SM, Chen SY, Chen KY, Lai TJ, Lin MT. Efficacy of extracorporeal shock wave therapy for post-stroke spasticity and dose-response analysis: a meta-analysis of randomized controlled trials. Eur J Phys Rehabil Med. 2025 Dec;61(6):787-797. doi: 10.23736/S1973-9087.25.08796-9.
- Background: PubMed 29072044Wu YT, Chang CN, Chen YM, Hu GC. Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):518-525. doi: 10.23736/S1973-9087.17.04801-8. Epub 2017 Oct 25.
- Background: PubMed 26798605Park DS, Kwon DR, Park GY, Lee MY. Therapeutic Effect of Extracorporeal Shock Wave Therapy According to Treatment Session on Gastrocnemius Muscle Spasticity in Children With Spastic Cerebral Palsy: A Pilot Study. Ann Rehabil Med. 2015 Dec;39(6):914-21. doi: 10.5535/arm.2015.39.6.914. Epub 2015 Dec 29.
- Background: PubMed 36846123Duan H, Lian Y, Jing Y, Xing J, Li Z. Research progress in extracorporeal shock wave therapy for upper limb spasticity after stroke. Front Neurol. 2023 Feb 9;14:1121026. doi: 10.3389/fneur.2023.1121026. eCollection 2023.
- Background: PubMed 35412036Mihai EE, Popescu MN, Iliescu AN, Berteanu M. A systematic review on extracorporeal shock wave therapy and botulinum toxin for spasticity treatment: a comparison on efficacy. Eur J Phys Rehabil Med. 2022 Aug;58(4):565-574. doi: 10.23736/S1973-9087.22.07136-2. Epub 2022 Apr 12.
- Background: PubMed 40740180Ozbek IC, Tikiz C. Effectiveness of radial extracorporeal shock wave therapy in post-stroke spasticity patients: Evaluation with shear wave elastography. Turk J Phys Med Rehabil. 2024 Dec 27;71(2):206-215. doi: 10.5606/tftrd.2025.14800. eCollection 2025 Jun.
- Background: PubMed 38957349Tur Segura M, Gimeno Esteve F, Biedermann Villagra T, Jimenez Redondo J, Garcia Rodriguez N, Mila Villarroel R. Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: study protocol for a randomized controlled trial. Front Neurol. 2024 Jun 13;15:1402452. doi: 10.3389/fneur.2024.1402452. eCollection 2024.
- Background: PubMed 35275569Wardhani RK, Wahyuni LK, Laksmitasari B, Lakmudin A. Effect of total number of pulses of radial extracorporeal shock wave therapy (rESWT) on hamstring muscle spasticity in children with spastic type cerebral palsy: A randomized clinical trial. J Pediatr Rehabil Med. 2022;15(1):159-164. doi: 10.3233/PRM-200796.
- Institutional websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to the small sample size and privacy considerations for pediatric participants.
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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, Dr principal investigator
Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Extracorporeal Shock Wave Therapy and Radial Extracorporeal Shock Wave Therapy in people with Spastic Quadriplegia and Cerebral Palsy (CP), run by Dr Cipto Mangunkusumo General Hospital 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 4 inclusion and 5 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 26 Oct 2026. 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?
The Modified Ashworth Scale (MAS) score of the gastrocnemius muscle (time frame: The primary outcome was evaluated at baseline, post-intervention weeks 1 to 4, and follow-up at 4, 8, and 12 weeks post-final treatment by blinded outcome assessor.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07894003, which also lists 12 linked publications.
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 26 Oct 2026.