Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311526
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity a Pilot Study
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SASHA
Brief Summary:
Spasticity common after a stroke aggravates the patients motor impairment causing pain and limitation in daily activities such as eating dressing and walking
There are different spasticity treatments such as botulinum neurotoxin in the first place Among the emerging therapies is focal extracorporeal shock wave therapy consisting of a sequence of sonic mechanical impulses with high peak pressure
Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity Moreover the shock waves therapeutic effect can last up to 12 weeks from the last treatment session
When used to treat stroke spasticity the shock waves mechanism of action is poorly detailed
On the one side shock waves could change the physical properties of the muscular tissue eg viscosity rigidity
On the other the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors eg muscle spindles This activation would modulate in turn the spinal and supra-spinal circuits involved in spasticity
To our knowledge no study investigated the shock waves mechanism of action in stroke upper limb spasticity
Research question do shock waves exert their therapeutic effect on spasticity by changing the muscles physical properties or by indirectly modulating the excitability of spinal circuits
Specific aims To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke
Two major hypotheses will be contrasted shock waves reduce hypertonia 1 by changing the muscles physical features or 2 by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits
Shock wave therapy is expected to improve spasticity thus improving the following clinical tests the Modified Ashworth Scale an ordinal score of spasticity and the Functional Assessment for Upper Limb FAST-UL an ordinal score of upper limb dexterity
This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds such as an improvement in the Heckmatt scale an ordinal score of muscle echotexture in spasticity
Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters a reduction of the HMmax ratio an index of hyperexcitability of the monosynaptic stretch reflex circuit a decrease in amplitude of the F waves a neurophysiological signal reflecting the excitability of singlerestricted motoneurones and an increase of the homosynaptic depression also known as post-activation depression reflecting the excitability of the transmission between the Ia fibres and motoneurones
Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment
If the shock waves exert their therapeutic effect by changing the muscles physical properties they could be more appropriate for patients with muscle fibrosis on ultrasounds
On the contrary if the shock waves work on spasticity by indirectly acting on the nervous systems excitability then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations which could be the muscles benefitting the most from this treatment
There are different spasticity treatments such as botulinum neurotoxin in the first place Among the emerging therapies is focal extracorporeal shock wave therapy consisting of a sequence of sonic mechanical impulses with high peak pressure
Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity Moreover the shock waves therapeutic effect can last up to 12 weeks from the last treatment session
When used to treat stroke spasticity the shock waves mechanism of action is poorly detailed
On the one side shock waves could change the physical properties of the muscular tissue eg viscosity rigidity
On the other the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors eg muscle spindles This activation would modulate in turn the spinal and supra-spinal circuits involved in spasticity
To our knowledge no study investigated the shock waves mechanism of action in stroke upper limb spasticity
Research question do shock waves exert their therapeutic effect on spasticity by changing the muscles physical properties or by indirectly modulating the excitability of spinal circuits
Specific aims To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke
Two major hypotheses will be contrasted shock waves reduce hypertonia 1 by changing the muscles physical features or 2 by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits
Shock wave therapy is expected to improve spasticity thus improving the following clinical tests the Modified Ashworth Scale an ordinal score of spasticity and the Functional Assessment for Upper Limb FAST-UL an ordinal score of upper limb dexterity
This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds such as an improvement in the Heckmatt scale an ordinal score of muscle echotexture in spasticity
Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters a reduction of the HMmax ratio an index of hyperexcitability of the monosynaptic stretch reflex circuit a decrease in amplitude of the F waves a neurophysiological signal reflecting the excitability of singlerestricted motoneurones and an increase of the homosynaptic depression also known as post-activation depression reflecting the excitability of the transmission between the Ia fibres and motoneurones
Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment
If the shock waves exert their therapeutic effect by changing the muscles physical properties they could be more appropriate for patients with muscle fibrosis on ultrasounds
On the contrary if the shock waves work on spasticity by indirectly acting on the nervous systems excitability then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations which could be the muscles benefitting the most from this treatment
Detailed Description:
None
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