Extracorporeal Shock Wave TherapyNCT05360316
Extracorporeal Shock Wave Therapy Applied to the Plantar Region in Individuals With Hemiplegia
A study testing ESWT in people with Extracorporeal Shock Wave Therapy and Kinaesthesia, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Sensory and balance losses occur in hemiplegic patients. In some patients, sensory and balance rehabilitations may vary depending on the treatment they receive, depending on the treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Extracorporeal Shock Wave Therapy, Kinaesthesia, Sensory Disorders
- What is being tested?
- ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2020to 4 May 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-ever hemiplegia
- Hemiplegia duration of at least 6 months
- Ability to walk alone without an orthosis.
Who cannot join
- Patients with ataxia, dystonia, or dyskinesia
- Patients with dementia
- Patients with bilateral hemiplegia
- Taking antispastic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy Applied to the Plantar Region in Individuals With Hemiplegia on Mobility, Plantar Pressure Distribution and Sensory
Sensory and balance losses occur in hemiplegic patients. In some patients, sensory and balance rehabilitations may vary depending on the treatment they receive, depending on the treatment. It is a fact that the affected anatomic neuronal regions can cause different damages for each person together with interneuronal relations. This study aims to sense sensation with Extracorporeal Shock Wave Therapy to be applied to the plantar region.
Read the detailed description
Every year in England and Wales, 110,000 people experience first stroke and 30,000 people experience other stroke events following the first stroke. Stroke is one of the most important events causing severe distress and is shown as the third most common cause of death in England. Most of the health and social care resources budget uses it to meet the acute and chronic care of stroke patients. 5% of all hospital expenses are spent for the care of stroke patients. Stroke causes 88% of the death causes of the 65 and over life group and 10-12% of all deaths in industrial countries. Stroke can always be an obstacle in patients and cause them to need long-term care. After the stroke, patients apply to the hospital due to psychological, social and physical problems. The sudden loss of functionality creates strong stress not only in the patient but also in the family. Neurological damage can also become irreversible distress. Signs and symptoms related to stroke vary depending on the localization and severity of the damage. Stroke often results in paralysis of one side of the body. Paralysis of one side of the body occurs on the opposite side of the damaged side of the brain. Stopping blood flow to the brain causes focal function loss up to various levels in the patient. The most common motor is loss. Other neurological losses are visual, sensory, communicative, swallowing and perceptual problems.
Kinesthesis and vibration losses are especially evident in the distal parts of the extremities. Kinesthesis and loss of position sense cause irregular and excessively flawed movements that are performed voluntarily with insufficient information about proprioception to the sensory cortex. Such patients are able to stand or walk, although they are not very balanced, as they can somewhat assess the position of their body parts with the sense of vision; but they have great difficulty walking in the dark.
Shock waves have been used extensively to study their effects on sensory nerves and nerve endings. Application of 1000 impulses of shock waves (0.08 mJ/mm, 2.4 Hz) resulted in the degeneration of sensory nerve fibers and endings followed by reinnervation of the affected skin areas These changes were accompanied by the reversible and rapid loss of the immunohistochemical markers protein gene product 9.5 and calcitonin gene-related peptide. However, a second application of the same dose of shock waves had a cumulative effect on the treated nerves, leading to delayed reinnervation. It appears, therefore, that shock wave-treated nerves develop a "memory effect" after the first treatment, and Extracorporeal Shock Wave Therapy (ESWT) repeated shortly after the first treatment is not beneficial. It is expected that ESWT induces subtle changes in the affected neurons whose axons have been treated. Investigators detected an increased expression of activating transcription factor 3 (ATF-3) and growth-associated phosphoprotein 43 (GAP-43) in dorsal root ganglion neurons of shock wave-treated rats, indicating that the molecular changes after ESWT are not restricted to the treated axons: their cell bodies are also activated in a retrograde manner. The question remains open as to whether doses of ESWT in the therapeutic range would induce similar changes as the 2000 impulses applied in this study. ATF-3 and GAP-43 are markers thought to be associated with the activation of neurons and glial cells (Schwann cells) after peripheral nerve injuries.
As regards the dose-effect relationship of ESWT on peripheral nerves, a large body of evidence suggests that shock wave doses greater than 900 impulses combined with a flux density of 0.08 mJ/mm2 induce damage to the affected nerves, manifested in impaired electrophysiological conduction parameters, a disrupted neurofilament staining pattern of the treated axons, and degeneration of the myelin sheaths at the levels of light and electron microscopy. These doses appeared to damage motor and sensory nerves equally. This experimental and clinical experience indicates that the therapeutically applicable dose for the promotion of nerve regeneration without side effects is likely to be lower than 500 impulses. The effect of such doses is highly dependent on the depth of the target tissue and the treated surface area.
In this study, the effect of ESWT on sensory nerves will be used in individuals with hemiplegia. Thus, mobility and plantar region sensory development of plantar sensory stimulation will be evaluated in individuals with hemiplegia. A study specific to the literature will be presented by evaluating the effect of evaluation results on the function.
- Being tested
- ESWT
- Keywords
- Extracorporeal Shock Wave Therapy, Kineaesthesia, Hemiplegia, Deep sense, Superficial sense
- Medical subject headings
- Sensation Disorders, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
extracorporeal shock wave therapy
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Placebo comparator | Patients assigned to the ESWT group received ESWT over the plantar fascia, three days/week, for six weeks. In addition patients participated additional in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training. Receives: Device: ESWT |
| Placebo | No intervention | Routine therapy Patients participated in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg Balance Scale (BBS): The BBS is a 14-item test of functional balance, with each item rated out of 4 for a total score of 56. It assesses static balance in sitting and standing, as well as dynamic balance during transitions and while in standing. Individuals who are able to maintain their balance for each task score higher on this outcome.
Measured: 3 mounths
Maximum plantar pressure
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure maximum plantar pressure
Measured: 3 Mounths
Static posture
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure static posture
Measured: 3 Mounths
Step cycle duration
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step cycle duration
Measured: 3 Mounths
Single-support phase
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure single-support phase
Measured: 3 Mounths
Swing phase
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure swing phase
Measured: 3 Mounths
Step length
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step length
Measured: 3 Mounths
Foot angle
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure foot angle
Measured: 3 Mounths
Cadence
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure cadence
Measured: 3 Mounths
Gait cycle distance
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure
Measured: 3 Mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start4 Jan 2020
- Primary completion4 Apr 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Shock Wave TherapyStudies 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
- Model description
- randomized controlled, double blind
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
- Investigators
- Gulnihal Deniz, Asst. Prof., Study chair, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360316
- Sponsor's protocol ID
- Firat Uni
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy Applied to the Plantar Region in Individuals With Hemiplegia on Mobility, Plantar Pressure Distribution and Sensory
- ClinicalTrials.gov ID
- NCT05360316
- Acronym / sponsor ID
- Firat Uni
- Keywords
- Extracorporeal Shock Wave Therapy, Kineaesthesia, Hemiplegia, Deep sense, Superficial sense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 4 Apr 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 4 May 2022 (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.
Sensory and balance losses occur in hemiplegic patients. In some patients, sensory and balance rehabilitations may vary depending on the treatment they receive, depending on the treatment. It is a fact that the affected anatomic neuronal regions can cause different damages for each person together with interneuronal relations. This study aims to sense sensation with Extracorporeal Shock Wave Therapy to be applied to the plantar region.
Detailed description
Every year in England and Wales, 110,000 people experience first stroke and 30,000 people experience other stroke events following the first stroke. Stroke is one of the most important events causing severe distress and is shown as the third most common cause of death in England. Most of the health and social care resources budget uses it to meet the acute and chronic care of stroke patients. 5% of all hospital expenses are spent for the care of stroke patients. Stroke causes 88% of the death causes of the 65 and over life group and 10-12% of all deaths in industrial countries. Stroke can always be an obstacle in patients and cause them to need long-term care. After the stroke, patients apply to the hospital due to psychological, social and physical problems. The sudden loss of functionality creates strong stress not only in the patient but also in the family. Neurological damage can also become irreversible distress. Signs and symptoms related to stroke vary depending on the localization and severity of the damage. Stroke often results in paralysis of one side of the body. Paralysis of one side of the body occurs on the opposite side of the damaged side of the brain. Stopping blood flow to the brain causes focal function loss up to various levels in the patient. The most common motor is loss. Other neurological losses are visual, sensory, communicative, swallowing and perceptual problems.
Kinesthesis and vibration losses are especially evident in the distal parts of the extremities. Kinesthesis and loss of position sense cause irregular and excessively flawed movements that are performed voluntarily with insufficient information about proprioception to the sensory cortex. Such patients are able to stand or walk, although they are not very balanced, as they can somewhat assess the position of their body parts with the sense of vision; but they have great difficulty walking in the dark.
Shock waves have been used extensively to study their effects on sensory nerves and nerve endings. Application of 1000 impulses of shock waves (0.08 mJ/mm, 2.4 Hz) resulted in the degeneration of sensory nerve fibers and endings followed by reinnervation of the affected skin areas These changes were accompanied by the reversible and rapid loss of the immunohistochemical markers protein gene product 9.5 and calcitonin gene-related peptide. However, a second application of the same dose of shock waves had a cumulative effect on the treated nerves, leading to delayed reinnervation. It appears, therefore, that shock wave-treated nerves develop a "memory effect" after the first treatment, and Extracorporeal Shock Wave Therapy (ESWT) repeated shortly after the first treatment is not beneficial. It is expected that ESWT induces subtle changes in the affected neurons whose axons have been treated. Investigators detected an increased expression of activating transcription factor 3 (ATF-3) and growth-associated phosphoprotein 43 (GAP-43) in dorsal root ganglion neurons of shock wave-treated rats, indicating that the molecular changes after ESWT are not restricted to the treated axons: their cell bodies are also activated in a retrograde manner. The question remains open as to whether doses of ESWT in the therapeutic range would induce similar changes as the 2000 impulses applied in this study. ATF-3 and GAP-43 are markers thought to be associated with the activation of neurons and glial cells (Schwann cells) after peripheral nerve injuries.
As regards the dose-effect relationship of ESWT on peripheral nerves, a large body of evidence suggests that shock wave doses greater than 900 impulses combined with a flux density of 0.08 mJ/mm2 induce damage to the affected nerves, manifested in impaired electrophysiological conduction parameters, a disrupted neurofilament staining pattern of the treated axons, and degeneration of the myelin sheaths at the levels of light and electron microscopy. These doses appeared to damage motor and sensory nerves equally. This experimental and clinical experience indicates that the therapeutically applicable dose for the promotion of nerve regeneration without side effects is likely to be lower than 500 impulses. The effect of such doses is highly dependent on the depth of the target tissue and the treated surface area.
In this study, the effect of ESWT on sensory nerves will be used in individuals with hemiplegia. Thus, mobility and plantar region sensory development of plantar sensory stimulation will be evaluated in individuals with hemiplegia. A study specific to the literature will be presented by evaluating the effect of evaluation results on the function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled, double blind
| Arm | Type | Receives |
|---|---|---|
| ESWT | Placebo comparator | Device: ESWTPatients assigned to the ESWT group received ESWT over the plantar fascia, three days/week, for six weeks. In addition patients participated additional in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training. |
| Placebo | No intervention | –Routine therapy Patients participated in the same conventional stroke rehabilitation program consisting of 60 minutes of treatment a day, five times a week for six weeks (30 sessions). The conventional therapy programs were patient-specific and consisted mainly of physiotherapy, such as neurodevelopmental facilitation techniques, passive mobilization, occupational therapy, postural control exercises, stretching and range-of-motion exercises for the hemiparetic side and balance training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-ever hemiplegia
- Hemiplegia duration of at least 6 months
- Ability to walk alone without an orthosis.
Key exclusion criteria (4 listed)
- Patients with ataxia, dystonia, or dyskinesia
- Patients with dementia
- Patients with bilateral hemiplegia
- Taking antispastic drugs
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 |
|---|---|---|
| ESWTextracorporeal shock wave therapy | Device | ESWT |
Primary outcome
Balance
Time frame: 3 mounths
Berg Balance Scale (BBS): The BBS is a 14-item test of functional balance, with each item rated out of 4 for a total score of 56. It assesses static balance in sitting and standing, as well as dynamic balance during transitions and while in standing. Individuals who are able to maintain their balance for each task score higher on this outcome.
Maximum plantar pressure
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure maximum plantar pressure
Static posture
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure static posture
Step cycle duration
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step cycle duration
Single-support phase
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure single-support phase
Swing phase
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure swing phase
Step length
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure step length
Foot angle
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure foot angle
Cadence
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure cadence
Gait cycle distance
Time frame: 3 Mounths
The Win-Track platform (MEDICAPTEURS Technology, France) is a tool used to measure
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 4 May 2022.
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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.
Gulnihal Deniz, Asst. Prof. study chair
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT in people with Extracorporeal Shock Wave Therapy and Kinaesthesia, run by Firat University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 4 May 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Balance (time frame: 3 mounths). The study lists 10 primary outcomes in all. 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 4 May 2022.