StrokeNCT04312581
Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
A study testing Extracorporeal shock wave therapy and Conventional rehabilitation in people with Stroke and Spasticity, run by Tanta University at 1 site in Egypt.
Trial summary
40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Stroke, Spasticity, Shock Wave
- What is being tested?
- Extracorporeal shock wave therapy and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2020to 29 Jul 2020
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.
Who cannot join
- Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist \& hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study
40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program.
Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.
- Conditions
- Stroke, Spasticity, Shock Wave
- Being tested
- Extracorporeal shock wave therapy, Conventional rehabilitation
- Keywords
- shock wave
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyDevice
3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.
Conventional rehabilitationOther
physical \& occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| First group (shock wave) | Experimental | Extracorporeal shock wave therapy Receives: Device: Extracorporeal shock wave therapy |
| Second group (conventional rehabilitation) | Active comparator | conventional rehabilitation Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
is a valid scoring system for spasticity
Measured: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Fugl-Meyer Assessment
reliable assessment tool for sensorimotor function of the upper extremity of stroke patients
Measured: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Motricity Index
used to assess the motor impairment in a patient with stroke, only one item (pinch grip) was tested using a 2.5 cm cube between the thumb and forefinger
- 19 points are given if able to grip cube but not hold it against gravity
- 22 points are given if able to hold cube against gravity but not against a weak pull
- 26 points are given if able to hold the cube against a weak pull but strength is weaker than normal
Measured: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Hmax / Mmax amplitude ratio
H reflex is an electrically triggered spinal reflex with a fairly constant latency and amplitude on repeated testing.Hmax / Mmax amplitude ratio was obtained from patient's spastic upper limb, flexor carpi radials muscle
Measured: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start21 Mar 2020
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samar abd alhamed tabra, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312581
- Sponsor's protocol ID
- 101
- Status last verified
- Aug 2020
- First submitted
- 12 Mar 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
PubMed 27149465
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients :Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04312581
- Acronym / sponsor ID
- 101
- Conditions
- Stroke, Spasticity, Shock Wave
- Keywords
- shock wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 18 Mar 2020 (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.
40 chronic stroke patients with upper limb spasticity will randomly divided into two groups. First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with one week apart without cessation of current physical therapy, while the second group will continue to receive conventional rehabilitative program.
Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group (shock wave) | Experimental | Device: Extracorporeal shock wave therapyExtracorporeal shock wave therapy |
| Second group (conventional rehabilitation) | Active comparator | Other: Conventional rehabilitationconventional rehabilitation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic stroke with disease duration more than one year will be included in the study with stable modified Ashworth scale for upper limb spasticity ranged from 1+ to 4.
Key exclusion criteria (1 listed)
- Patients more than 65 years,Patients with double stroke and patients with fixed contractures of wrist \& hand ,Patients received anti-spastic measures (botulinum toxins, nerve block) within 6 months,Also patients with contraindication to extra-corporeal shock wave therapy i.e. malignancy at treatment area, coagulopathies, active infection (viral or TB), o bleeding wounds, and patients with pacemakers will be excluded
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 shock wave therapy3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency. | Device | First group (shock wave) |
| Conventional rehabilitationphysical \& occupational therapy | Other | Second group (conventional rehabilitation) |
Primary outcome
Modified Ashworth Scale
Time frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
is a valid scoring system for spasticity
Fugl-Meyer Assessment
Time frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
reliable assessment tool for sensorimotor function of the upper extremity of stroke patients
Motricity Index
Time frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
used to assess the motor impairment in a patient with stroke, only one item (pinch grip) was tested using a 2.5 cm cube between the thumb and forefinger * 19 points are given if able to grip cube but not hold it against gravity * 22 points are given if able to hold cube against gravity but not against a weak pull * 26 points are given if able to hold the cube against a weak pull but strength is weaker than normal
Hmax / Mmax amplitude ratio
Time frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)
H reflex is an electrically triggered spinal reflex with a fairly constant latency and amplitude on repeated testing.Hmax / Mmax amplitude ratio was obtained from patient's spastic upper limb, flexor carpi radials muscle
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 1 Sep 2020.
- Results publication: PubMed 27149465Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
- Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic StrokeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 shock wave therapy and Conventional rehabilitation in people with Stroke and Spasticity, run by Tanta University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 1 Sep 2020. 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 Egypt. 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?
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?
Modified Ashworth Scale (time frame: Change from Pre to Post 1 [after 3rd session (after 2 weeks from baseline) ] and Post 2 (3 months follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312581, which also lists 1 linked publication.
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 1 Sep 2020.