Cerebral PalsyNCT05702606
Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
A study testing Radial extracorporeal shock wave therapy (rESWT) in people with Cerebral Palsy and Spasticity, Muscle, run by Fundacio Aspace Catalunya at 1 site in Spain.
Trial summary
Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential… Read more about this study
- Who is it for?
- Ages 4 to 50 years
- Conditions the study is for
- Cerebral Palsy, Spasticity, Muscle, Extracorporeal Shock Wave Therapy
- What is being tested?
- Radial extracorporeal shock wave therapy (rESWT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2021to 3 Oct 2022
- 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 4 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CP.
- With a CP classified as spastic.
- Spasticity in the Triceps Surae muscle.
- Who have a Gross Motor Classification (GMFCS) level between l and ll
- Having signed the informed consent by the participant or your legal guardian
Who cannot join
- Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study.
- Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study.
- Patients who have undergone surgery for deformities foot orthotics in the last year.
- Fixed deformities in the ankle joint.
- Clinical signs of myopathy and neuropathy.
- Infection or tumor at the site of application of the therapy*.
Show all 10Show fewer
- Severe blood dyscrasia*.
- Blood coagulation disorders*.
- Treatment with oral anticoagulants*
- Contraindications of radial extracorporeal shock wave therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.
- Being tested
- Radial extracorporeal shock wave therapy (rESWT)
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shock wave therapy (rESWT)Other
Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 3 rESWT sessions with a time interval of 1 week between each session. Receives: Other: Radial extracorporeal shock wave therapy (rESWT) |
| Experimental Group A | Experimental | 3 rESTW sessions with a time interval of 2 weeks between each session. Receives: Other: Radial extracorporeal shock wave therapy (rESWT) |
| Experimental Group B | Experimental | 3 rESTW sessions with a time interval of 4 weeks between each session. Receives: Other: Radial extracorporeal shock wave therapy (rESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer
Measured: Base line,3,5,9,12 and 24 weeks
Change in goal attainment scale (GAS)
Goal attainment scale: Definition of an individual goal at the start. Will be assess the achievement or not of an objective and evaluates the expectations of improvement in each of the goals with a numerical scale from -2 to +2:
(-2) Result much lower than expected (-1) Lower than expected result (0) Expected result (+1) Result higher than expected (+2) Result much higher than expected
Measured: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks
Secondary outcomes (3)
Pain secondary to spasticity assessed by the visual analog scale
If the patient presents pain secondary to spasticity, evaluate the degree of improvement after therapy using the visual analog scale where the value 0 is no pain and 10 is the worst possible pain.
Measured: Base line,3,5,9,12 and 24 weeks
Satisfaction with the therapy assessed by the visual analog scale
Evaluate the degree of improvement perceived by the patient in relation to the therapy using the visual analog scale where the value 0 is no perceived improvement and 10 is the maximum expected improvement
Measured: Base line,3,5,9,12 and 24 weeks
Adverse effects by Data collection notebook
Possible adverse effects secondary to treatment such as small bruises, petechiae, or muscle fatigue will be recorded in the data collection notebook
Measured: Base line,3,5,9,12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start10 Jun 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Aspace Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Míriam Tur, Fundacio Aspace Catalunya
- Investigators
- Míriam Tur Segura, First, Principal investigator, Fundació Aspace CatalunyaRaimon Milà Villarroel, third, Study director, Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702606
- Sponsor's protocol ID
- ASP_Shock_MT
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
PubMed 23346889Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010 Jan 26;74(4):336-43. doi: 10.1212/WNL.0b013e3181cbcd2f.
PubMed 20101040National Collaborating Centre for Women's and Children's Health (UK). Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications. London: RCOG Press; 2012 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK116583/
PubMed 23346608Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.
PubMed 22014321Benini R, Shevell MI. Updates in the treatment of spasticity associated with cerebral palsy. Curr Treat Options Neurol. 2012 Dec;14(6):650-9. doi: 10.1007/s11940-012-0192-7.
PubMed 22851256Ogden JA, Alvarez RG, Levitt R, Marlow M. Shock wave therapy (Orthotripsy) in musculoskeletal disorders. Clin Orthop Relat Res. 2001 Jun;(387):22-40. doi: 10.1097/00003086-200106000-00005.
PubMed 11400888Schmitz C, Csaszar NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull. 2015;116(1):115-38. doi: 10.1093/bmb/ldv047. Epub 2015 Nov 18.
PubMed 26585999Mattyasovszky SG, Langendorf EK, Ritz U, Schmitz C, Schmidtmann I, Nowak TE, Wagner D, Hofmann A, Rommens PM, Drees P. Exposure to radial extracorporeal shock waves modulates viability and gene expression of human skeletal muscle cells: a controlled in vitro study. J Orthop Surg Res. 2018 Apr 6;13(1):75. doi: 10.1186/s13018-018-0779-0.
PubMed 29625618Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
PubMed 16109905Amelio E, Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: a placebo-controlled study. J Rehabil Med. 2010 Apr;42(4):339-43. doi: 10.2340/16501977-0522.
PubMed 20358168Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.
PubMed 22207070Vidal X, Marti-Fabregas J, Canet O, Roque M, Morral A, Tur M, Schmitz C, Sitja-Rabert M. Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study. J Rehabil Med. 2020 Jun 30;52(6):jrm00076. doi: 10.2340/16501977-2703.
PubMed 32556354Tur Segura M, Morral A, Gimeno Esteve F, Biedermann Villagra T, Mangas Hernandez A, Ancosta Diez S, Jimenez Redondo J, Garcia Rodriguez N, Mila Villarroel R. Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: a randomized controlled trial with different time intervals between sessions. Front Neurol. 2026 Jun 5;17:1775659. doi: 10.3389/fneur.2026.1775659. eCollection 2026.
PubMed 42327806Tur 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 38957349
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05702606
- Acronym / sponsor ID
- ASP_Shock_MT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fundacio Aspace CatalunyaUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 27 Jan 2023 (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 is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Radial extracorporeal shock wave therapy (rESWT)3 rESWT sessions with a time interval of 1 week between each session. |
| Experimental Group A | Experimental | Other: Radial extracorporeal shock wave therapy (rESWT)3 rESTW sessions with a time interval of 2 weeks between each session. |
| Experimental Group B | Experimental | Other: Radial extracorporeal shock wave therapy (rESWT)3 rESTW sessions with a time interval of 4 weeks between each session. |
Who may qualify
- Ages
- 4 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with CP.
- With a CP classified as spastic.
- Spasticity in the Triceps Surae muscle.
- Who have a Gross Motor Classification (GMFCS) level between l and ll
- Having signed the informed consent by the participant or your legal guardian
Key exclusion criteria (10 listed)
- Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study.
- Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study.
- Patients who have undergone surgery for deformities foot orthotics in the last year.
- Fixed deformities in the ankle joint.
- Clinical signs of myopathy and neuropathy.
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 shock wave therapy (rESWT)Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head | Other | Control Group, Experimental Group A, Experimental Group B |
Primary outcome
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
Time frame: Base line,3,5,9,12 and 24 weeks
Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer
Change in goal attainment scale (GAS)
Time frame: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks
Goal attainment scale: Definition of an individual goal at the start. Will be assess the achievement or not of an objective and evaluates the expectations of improvement in each of the goals with a numerical scale from -2 to +2: (-2) Result much lower than expected (-1) Lower than expected result (0) Expected result (+1) Result higher than expected (+2) Result much higher than expected
3 secondary outcomes
Pain secondary to spasticity assessed by the visual analog scale
Time frame: Base line,3,5,9,12 and 24 weeks
Satisfaction with the therapy assessed by the visual analog scale
Time frame: Base line,3,5,9,12 and 24 weeks
Adverse effects by Data collection notebook
Time frame: Base line,3,5,9,12 and 24 weeks
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 27 Jan 2023.
- Background: PubMed 23346889Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
- Background: PubMed 20101040Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010 Jan 26;74(4):336-43. doi: 10.1212/WNL.0b013e3181cbcd2f.
- Background: PubMed 23346608National Collaborating Centre for Women's and Children's Health (UK). Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications. London: RCOG Press; 2012 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK116583/
- Background: PubMed 22014321Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.
- Background: PubMed 22851256Benini R, Shevell MI. Updates in the treatment of spasticity associated with cerebral palsy. Curr Treat Options Neurol. 2012 Dec;14(6):650-9. doi: 10.1007/s11940-012-0192-7.
- Background: PubMed 11400888Ogden JA, Alvarez RG, Levitt R, Marlow M. Shock wave therapy (Orthotripsy) in musculoskeletal disorders. Clin Orthop Relat Res. 2001 Jun;(387):22-40. doi: 10.1097/00003086-200106000-00005.
- Background: PubMed 26585999Schmitz C, Csaszar NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull. 2015;116(1):115-38. doi: 10.1093/bmb/ldv047. Epub 2015 Nov 18.
- Background: PubMed 29625618Mattyasovszky SG, Langendorf EK, Ritz U, Schmitz C, Schmidtmann I, Nowak TE, Wagner D, Hofmann A, Rommens PM, Drees P. Exposure to radial extracorporeal shock waves modulates viability and gene expression of human skeletal muscle cells: a controlled in vitro study. J Orthop Surg Res. 2018 Apr 6;13(1):75. doi: 10.1186/s13018-018-0779-0.
- Background: PubMed 16109905Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
- Background: PubMed 20358168Amelio E, Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: a placebo-controlled study. J Rehabil Med. 2010 Apr;42(4):339-43. doi: 10.2340/16501977-0522.
- Background: PubMed 22207070Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.
- Background: PubMed 32556354Vidal X, Marti-Fabregas J, Canet O, Roque M, Morral A, Tur M, Schmitz C, Sitja-Rabert M. Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study. J Rehabil Med. 2020 Jun 30;52(6):jrm00076. doi: 10.2340/16501977-2703.
- Individual participant dataSharing planned: No
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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.
Míriam Tur Segura, First principal investigator
Fundació Aspace Catalunya
Raimon Milà Villarroel, third study director
Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull
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 shock wave therapy (rESWT) in people with Cerebral Palsy and Spasticity, Muscle, run by Fundacio Aspace Catalunya at 1 site in Spain.
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 5 inclusion and 10 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 27 Jan 2023. 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 Spain. 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?
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale (time frame: Base line,3,5,9,12 and 24 weeks). The study lists 2 primary outcomes in all. 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 NCT05702606, which also lists 14 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 27 Jan 2023.