Stroke, CerebralNCT06548321
Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP
A study testing Extracorporeal Shockwave Therapy in people with Stroke, Cerebral, run by Superior University at 1 site in Pakistan.
Trial summary
This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebral
- What is being tested?
- Extracorporeal Shockwave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 3rd stage of Stroke
Who cannot join
- Non spastic CP,1st stage of Stroke,Spasticity caused by injury,Newborn
Trial locations and contacts
1 site in 1 country.
About this study
This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.
Read the detailed description
ESWT therapy increses molecular and immunological reactions,increase blood microcirculation and neurovascularization.It enhancing the neural proliferation of neural stem cell(NSC),which shows repair in brain function in CNS diseases.Extracorporeal shockwave can produce Nitric oxide in enzymatic and non enzymatic way which help, to reduce muscle spasm.Extracorporeal Shockwave reduce the exitibilty of motor neuron by vibratory stimulation of tendon and reduces tension.After 2 weeks ESWT muscle tension reduces increases range of motion reduces the pain.shock wave therapy appears to be effective in reducing spasticity levels irrespective of the age of the participants, the type of injury, and the tool used to measure the effect.ESWT change in motor neuron exitibilty \& also associated with the spastic muscle.
- Conditions
- Stroke, Cerebral
- Being tested
- Extracorporeal Shockwave Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDiagnostic test
" The ESTW machine is turned on and the instrument, or shockwave gun, is pressed against the affected area. Rapid impulses are then delivered to the patient. Treatment typically lasts between 5 and 15 minutes. While this treatment can be uncomfortable for some, most do not experience any pain.
Once treatment is completed, patients should do their best to physical activity… higher levels of energy Shockwaves into deeper tissue locations… ESWT therapies can help treat neurological disorders like multiple sclerosis and the effects of stroke.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shockwave Therapy | Experimental | Not described Receives: Diagnostic Test: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale MAS
The Ashworth Scale method of grading spasticity, working with Cerebral Palsy and Stroke patients. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Since its modification, the modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CerebralStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548321
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/735
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Extracorporeal Shockwave Therapy to Reduce Spasticity in Stroke/CP
- ClinicalTrials.gov ID
- NCT06548321
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/735
- Conditions
- Stroke, Cerebral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
This Study will help to explain us that ExtracorporealShockwave therapy can reduce spasticity in Stroke Patient,help them to restore their abilities and ROM.Therapy reduces dependency rate of patient.Also seen this therapy shows reduction in spasticity of CP child population.Improving the motor recovery.
Detailed description
ESWT therapy increses molecular and immunological reactions,increase blood microcirculation and neurovascularization.It enhancing the neural proliferation of neural stem cell(NSC),which shows repair in brain function in CNS diseases.Extracorporeal shockwave can produce Nitric oxide in enzymatic and non enzymatic way which help, to reduce muscle spasm.Extracorporeal Shockwave reduce the exitibilty of motor neuron by vibratory stimulation of tendon and reduces tension.After 2 weeks ESWT muscle tension reduces increases range of motion reduces the pain.shock wave therapy appears to be effective in reducing spasticity levels irrespective of the age of the participants, the type of injury, and the tool used to measure the effect.ESWT change in motor neuron exitibilty \& also associated with the spastic muscle.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shockwave Therapy | Experimental | Diagnostic Test: Extracorporeal Shockwave Therapy |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 3rd stage of Stroke
Key exclusion criteria (1 listed)
- Non spastic CP,1st stage of Stroke,Spasticity caused by injury,Newborn
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 |
|---|---|---|
| Extracorporeal Shockwave Therapy" The ESTW machine is turned on and the instrument, or shockwave gun, is pressed against the affected area. Rapid impulses are then delivered to the patient. Treatment typically lasts between 5 and 15 minutes. While this treatment can be uncomfortable for some, most do not experience any pain. Once treatment is completed, patients should do their best to physical activity… higher levels of energy Shockwaves into deeper tissue locations… ESWT therapies can help treat neurological disorders like multiple sclerosis and the effects of stroke. | Diagnostic test | Extracorporeal Shockwave Therapy |
Primary outcome
Modified Ashworth Scale MAS
Time frame: 12 Months
The Ashworth Scale method of grading spasticity, working with Cerebral Palsy and Stroke patients. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. In 1987, while performing a study to exam interrater reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the Ashworth scale by adding 1+ to the scale to increase sensitivity. Since its modification, the modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Stroke, Cerebral, run by Superior University at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
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?
Modified Ashworth Scale MAS (time frame: 12 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 12 Aug 2024.