Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04546035
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2020-08-24
Brief Title:
Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy
Sponsor:
Rizky Kusuma Wardhani
Organization:
Indonesia University
Study Overview
Official Title:
Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 In 2016 more than 17 million people are affected by CP with a prevalence of 15 to 25 per 1000 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 US41 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
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 1000 pulses 1500 pulses and 2000 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 01 mJmm2 and the repetition frequency was at 4 Hz with a pressure of 15 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 1000 pulses group III 1500 pulses and group IV 2000 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 230 IBM Corporation Armonk NY USA The level of significance was set at 005
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 1000 pulses 1500 pulses and 2000 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 01 mJmm2 and the repetition frequency was at 4 Hz with a pressure of 15 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 1000 pulses group III 1500 pulses and group IV 2000 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 230 IBM Corporation Armonk NY USA The level of significance was set at 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None