SpasticityPhase 1NCT02400619
Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT
A Phase 1 study testing shock waves and Botulinum Toxin Type A in people with Spasticity and Cerebral Palsy, run by Xavi Vidal Novellas at 1 site in Spain.
Trial summary
Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the… Read more about this study
- Who is it for?
- Ages 5 to 55 years
- Conditions the study is for
- Spasticity, Cerebral Palsy
- What is being tested?
- shock waves and Botulinum Toxin Type A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 5 and 55 years
- Any level of GMFCS (Gross Motor Function Classification System)
- The patient consent to participate in the study
- Diagnosis of spastic cerebral palsy
- Triceps Surae spasticity in them.
- The dynamic foot deformity.
- Extensibility between 0 ° and 20 ° in dorsal flexion passive way.
- Do not be diagnosed important cutaneous alterations.
Who cannot join
- Associate neuromuscular disease.
- Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months.
- Fixed foot deformity.
- Etiology of factors:
- or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).
- Unable to follow the treatment.
- Allergy to botulinum toxin.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Piloto Arcangel Sant Gabriel. ASPACE
Barcelona, Barcelona, 08320
About this study
Official title: Efficacy of Radial Extracorporeal Shock Waves Compared to Botulinum Toxin Type A in the Treatment of Spasticity of the Lower Extremities in Patients With Cerebral Palsy: a Crossover Randomized Clinical Trial.
Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy
The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other
Read the detailed description
Outcome Measures:
The primary outcome will be to measure spasticity with passive range of motion of the foot (pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the intervention.
Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after the first application of each therapy. 2) Ascertain if the type of Gross Motor Functional Classification System (GMFCS) has an influence on the improvement of these two treatments; 3) Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on the results of study; and 4) Undergo a qualitative registration to know the perception and experience that patient/family will have during this study, through a satisfaction questionnaire.
- Conditions
- Spasticity, Cerebral Palsy
- Being tested
- shock waves, Botulinum Toxin Type A
- Keywords
- shockwaves, Physiotherapy, Botulinum toxin
- 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.
shock wavesDevice
Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE
Also called Type A
Botulinum toxin type A Botox
| Study group | Role | What they receive |
|---|---|---|
| shock waves | Active comparator | A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS. The other group will receive botulinum toxin Type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected, Botox (4-8-12 U/Kg) Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy. Receives: Device: shock waves |
| botulinum toxin | Active comparator | A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS.The other group will receive botulinum toxin type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected. Botox (4-8-12 U/Kg)Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry
Measured: up to three months
Secondary outcomes (3)
Evaluate the patients perceive pain
It shall be assessed by visual analog scale
Measured: after each therapy
Ascertain if the type of GMFCS has an influence on the improvement of these two treatments. Qualitative registation to achieve the percepcion and experience that have made the treatment received the patient/family.
Measured: at the end to study
To undergo a qualitative registration to know the perception and experience that patient/family will have during this study
Measured: at the end to study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xavi Vidal Novellas
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebral Palsy Association
- Responsible party
- Sponsor-investigator, Xavi Vidal Novellas, University Ramon Llull
- Investigators
- Vidal Novellas, Principal investigator, Aspace. Association of Cerebral Palsy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400619
- Sponsor's protocol ID
- Neuroshockwaves
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radial Extracorporeal Shock Waves Compared to Botulinum Toxin Type A in the Treatment of Spasticity of the Lower Extremities in Patients With Cerebral Palsy: a Crossover Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02400619
- Acronym / sponsor ID
- Neuroshockwaves
- Conditions
- Spasticity, Cerebral Palsy
- Keywords
- shockwaves, Physiotherapy, Botulinum toxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Xavi Vidal NovellasUniversity, hospital or other
- Collaborators
- Cerebral Palsy Association
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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 a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy
The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other
Detailed description
Outcome Measures:
The primary outcome will be to measure spasticity with passive range of motion of the foot (pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the intervention.
Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after the first application of each therapy. 2) Ascertain if the type of Gross Motor Functional Classification System (GMFCS) has an influence on the improvement of these two treatments; 3) Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on the results of study; and 4) Undergo a qualitative registration to know the perception and experience that patient/family will have during this study, through a satisfaction questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shock waves | Active comparator | Device: shock wavesA comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS. The other group will receive botulinum toxin Type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected, Botox (4-8-12 U/Kg) Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy. |
| botulinum toxin | Active comparator | Drug: Botulinum Toxin Type AA comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS.The other group will receive botulinum toxin type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected. Botox (4-8-12 U/Kg)Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy. |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age between 5 and 55 years
- Any level of GMFCS (Gross Motor Function Classification System)
- The patient consent to participate in the study
- Diagnosis of spastic cerebral palsy
- Triceps Surae spasticity in them.
Key exclusion criteria (7 listed)
- Associate neuromuscular disease.
- Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months.
- Fixed foot deformity.
- Etiology of factors:
- or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).
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 |
|---|---|---|
| shock wavesSwiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE | Device | shock waves |
| Botulinum Toxin Type AAlso: Type ABotulinum toxin type A Botox | Drug | botulinum toxin |
Primary outcome
muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry
Time frame: up to three months
3 secondary outcomes
Evaluate the patients perceive pain
Time frame: after each therapy
Ascertain if the type of GMFCS has an influence on the improvement of these two treatments. Qualitative registation to achieve the percepcion and experience that have made the treatment received the patient/family.
Time frame: at the end to study
To undergo a qualitative registration to know the perception and experience that patient/family will have during this study
Time frame: at the end to study
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 13 Mar 2017.
- Individual participant dataSharing planned: Yes
Related trials for Spasticity
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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
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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.
Vidal Novellas principal investigator
Aspace. Association of Cerebral Palsy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing shock waves and Botulinum Toxin Type A in people with Spasticity and Cerebral Palsy, run by Xavi Vidal Novellas 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 8 inclusion and 7 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 13 Mar 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry (time frame: up to three months). 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 13 Mar 2017.