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Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spasticity, Muscle, Extracorporeal Shock Wave Therapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radial extracorporeal shock wave therapy (rESWT)
Sponsored by
Fundacio Aspace Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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*. Severe blood dyscrasia*. Blood coagulation disorders*. Treatment with oral anticoagulants* Contraindications of radial extracorporeal shock wave therapy.

Sites / Locations

  • Fundació Aspace Catalunya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Experimental Group A

Experimental Group B

Arm Description

3 rESWT sessions with a time interval of 1 week between each session.

3 rESTW sessions with a time interval of 2 weeks between each session.

3 rESTW sessions with a time interval of 4 weeks between each session.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
November 29, 2022
Last Updated
January 26, 2023
Sponsor
Fundacio Aspace Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05702606
Brief Title
Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Official Title
Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio Aspace Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spasticity, Muscle, Extracorporeal Shock Wave Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
3 rESWT sessions with a time interval of 1 week between each session.
Arm Title
Experimental Group A
Arm Type
Experimental
Arm Description
3 rESTW sessions with a time interval of 2 weeks between each session.
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
3 rESTW sessions with a time interval of 4 weeks between each session.
Intervention Type
Other
Intervention Name(s)
Radial extracorporeal shock wave therapy (rESWT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
Description
Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer
Time Frame
Base line,3,5,9,12 and 24 weeks
Title
Change in goal attainment scale (GAS)
Description
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
Time Frame
Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks
Secondary Outcome Measure Information:
Title
Pain secondary to spasticity assessed by the visual analog scale
Description
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.
Time Frame
Base line,3,5,9,12 and 24 weeks
Title
Satisfaction with the therapy assessed by the visual analog scale
Description
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
Time Frame
Base line,3,5,9,12 and 24 weeks
Title
Adverse effects by Data collection notebook
Description
Possible adverse effects secondary to treatment such as small bruises, petechiae, or muscle fatigue will be recorded in the data collection notebook
Time Frame
Base line,3,5,9,12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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*. Severe blood dyscrasia*. Blood coagulation disorders*. Treatment with oral anticoagulants* Contraindications of radial extracorporeal shock wave therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Míriam Tur Segura, First
Organizational Affiliation
Fundació Aspace Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raimon Milà Villarroel, third
Organizational Affiliation
Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull
Official's Role
Study Director
Facility Information:
Facility Name
Fundació Aspace Catalunya
City
Barcelona
ZIP/Postal Code
08038
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23346889
Citation
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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.
Results Reference
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PubMed Identifier
20101040
Citation
Quality 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.
Results Reference
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PubMed Identifier
23346608
Citation
National 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/
Results Reference
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PubMed Identifier
22014321
Citation
Ramstad 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.
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PubMed Identifier
22851256
Citation
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Citation
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PubMed Identifier
26585999
Citation
Schmitz 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.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

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