StrokePTSNCT03814889

Passive Tactile Stimulation for Stroke Rehabilitation

A study testing Vibration pattern and No vibration in people with Stroke and Stroke, Ischemic, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?: Vibration pattern and No vibration
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 15 May 2019to 31 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 and older.
diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
able to provide informed consent.

Who cannot join

Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Neuroscience Health Center
Palo Alto, California, 94304

Other trials in United States

About this study

Conditions: Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke
Being tested: Vibration pattern, No vibration
Keywords: spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration
Medical subject headings: Stroke, Ischemic Stroke, Hemorrhagic Stroke, Muscle Spasticity, Hemiplegia, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vibration patternDevice
Vibration patterns applied to the affected limb based on pilot study results.
No vibrationDevice
These patients will wear a glove with a blinking light instead of feeling vibrations.

Study groups in NCT03814889
Study group	Role	What they receive
Acute Stimulation: Vibration pattern 1-3 and sham control	Active comparator	All participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off. Receives: Device: Vibration pattern; Device: No vibration
Longitudinal Stimulation: Vibration pattern 4	Active comparator	1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested. Receives: Device: Vibration pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Modified Ashworth at 12 Weeks
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Change from Baseline Modified Ashworth at 12 weeks
Change in Modified Ashworth at 8 Weeks
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale) Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: Change from Baseline Modified Ashworth at 8 weeks
Change in Range of Motion at 8 Weeks
Finger extension range.
Measured: Change from Baseline Range of Motion at 8 weeks
Change in Range of Motion at 12 Weeks
Finger extension range.
Measured: Change from Baseline Range of Motion at 12 weeks
Change in Modified Ashworth During Stimulation (Pattern 1).
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 20 minutes after stimulation start
Change in Modified Ashworth During Stimulation (Pattern 2).
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 20 minutes after stimulation start
Change in Modified Ashworth During Stimulation (Pattern 3).
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 20 minutes after stimulation start
Change in Modified Ashworth During Stimulation (Sham Control).
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.
Measures spastic hypertonia by manually moving an affected joint at set velocities.
Scores:
0 (0) - No increase in muscle tone
1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: 20 minutes after stimulation start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201931 Dec 2022

First posted24 Jan 2019
Study start15 May 2019
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 Stanford 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: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03814889
Sponsor's protocol ID: 49330
Acronym: PTS
Status last verified: Apr 2024
First submitted: 16 Jan 2019
Last updated: 8 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Seim C, Chen B, Han C, Vacek D, Wu LS, Lansberg M, Okamura A. Relief of post-stroke spasticity with acute vibrotactile stimulation: controlled crossover study of muscle and skin stimulus methods. Front Hum Neurosci. 2023 Aug 29;17:1206027. doi: 10.3389/fnhum.2023.1206027. eCollection 2023.
PubMed 37706171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Passive Tactile Stimulation for Stroke Rehabilitation
ClinicalTrials.gov ID: NCT03814889
Acronym / sponsor ID: PTS / 49330
Conditions: Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke
Keywords: spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 15 May 2019 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 24 Jan 2019 (actual)
Results: Posted 8 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acute Stimulation: Vibration pattern 1-3 and sham control	Active comparator	Device: Vibration pattern, Device: No vibrationAll participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.
Longitudinal Stimulation: Vibration pattern 4	Active comparator	Device: Vibration pattern1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18 and older.
diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
able to provide informed consent.

Key exclusion criteria (1 listed)

Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

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
Vibration patternVibration patterns applied to the affected limb based on pilot study results.	Device	Acute Stimulation: Vibration pattern 1-3 and sham control, Longitudinal Stimulation: Vibration pattern 4
No vibrationThese patients will wear a glove with a blinking light instead of feeling vibrations.	Device	Acute Stimulation: Vibration pattern 1-3 and sham control

Primary outcome

Change in Modified Ashworth at 12 Weeks
Time frame: Change from Baseline Modified Ashworth at 12 weeks
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth at 8 Weeks
Time frame: Change from Baseline Modified Ashworth at 8 weeks
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale) Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Range of Motion at 8 Weeks
Time frame: Change from Baseline Range of Motion at 8 weeks
Finger extension range.
Change in Range of Motion at 12 Weeks
Time frame: Change from Baseline Range of Motion at 12 weeks
Finger extension range.
Change in Modified Ashworth During Stimulation (Pattern 1).
Time frame: 20 minutes after stimulation start
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth During Stimulation (Pattern 2).
Time frame: 20 minutes after stimulation start
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth During Stimulation (Pattern 3).
Time frame: 20 minutes after stimulation start
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth During Stimulation (Sham Control).
Time frame: 20 minutes after stimulation start
Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension

Results and safety

Results posted to the registry on 8 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Stimulation: Vibration Pattern 1-3 and Sham Control	14	14
Longitudinal Stimulation: Vibration Pattern 4	0	0

Primary outcome: Change in Modified Ashworth at 12 Weeks

Time frame: Change from Baseline Modified Ashworth at 12 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control n = 0	Longitudinal Stimulation: Vibration Pattern 4 n = 20
Value	–	1.1 (0.22)

Longitudinal Stimulation: Vibration Pattern 4: p = 0.00025, Wilcoxon Signed-Rank

Population analysed: This measure was conducted on only one group.

Primary outcome: Change in Modified Ashworth at 8 Weeks

Time frame: Change from Baseline Modified Ashworth at 8 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Vibration Patterns 1-3 and Sham Control n = 0	Vibration Pattern 4 n = 20
Value	–	0.9 (0.28)

Vibration Pattern 4: p = 0.0014, Wilcoxon Signed-Rank

Population analysed: This measure was conducted on only one group.

Primary outcome: Change in Range of Motion at 8 Weeks

Time frame: Change from Baseline Range of Motion at 8 weeks. Mean (Standard Error). Unit: degrees of finger extension

Measure	Vibration Patterns 1-3 and Sham Control n = 0	Vibration Pattern 4 n = 20
Value	–	11.6 (5.2)

Vibration Pattern 4: p = 0.02, t-test, 1 sided

Population analysed: This measure was conducted on only one group.

Primary outcome: Change in Range of Motion at 12 Weeks

Time frame: Change from Baseline Range of Motion at 12 weeks. Mean (Standard Error). Unit: degrees of finger extension

Measure	Vibration Patterns 1-3 and Sham Control n = 0	Vibration Pattern 4 n = 20
Value	–	18.4 (4.3)

Vibration Pattern 4: p = 0.001, t-test, 1 sided

Population analysed: This measure was conducted on only one group.

Adverse events

Time frame: Adverse Events monitored/assessed up to one month for Vibration Pattern 1-3 and Sham Control Arms and up to three-six months for Vibration Pattern 4 Arm. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vibration Pattern 1	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Vibration Pattern 2	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Vibration Pattern 3	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Sham Control	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Vibration Pattern 4	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37706171Seim C, Chen B, Han C, Vacek D, Wu LS, Lansberg M, Okamura A. Relief of post-stroke spasticity with acute vibrotactile stimulation: controlled crossover study of muscle and skin stimulus methods. Front Hum Neurosci. 2023 Aug 29;17:1206027. doi: 10.3389/fnhum.2023.1206027. eCollection 2023.
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.

Allison M Okamura, PhD principal investigator

Stanford 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 Vibration pattern and No vibration in people with Stroke and Stroke, Ischemic, run by Stanford University at 1 site in United States.

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 4 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 8 Apr 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Modified Ashworth at 12 Weeks (time frame: Change from Baseline Modified Ashworth at 12 weeks). The study lists 8 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 NCT03814889, 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 8 Apr 2024.