StrokeNCT04632186
Development of an Electronic Suit to Reduce Hemiplegic Shoulder Pain
A study testing EXOPULSE Mollii suit in people with Stroke and Pain, Shoulder, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a Swedish Med-tech company. Based on theoretical background and clinical experience, this study will explore the potential value of the EXOPULSE Mollii suit-method in the management of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Pain, Shoulder, Technology
- What is being tested?
- EXOPULSE Mollii suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 9 Aug 2020to 30 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will have suffered a stroke > 6 months earlier and are living with hemiplegia affecting the right or the left side of the body including the upper extremity. They will have developed hemiplegic shoulder pain within the first 6 months after stroke onset. Moreover, eligible study participants will be able to understand instructions as well as written and oral study information and can express informed consent. Furthermore, study participants need to pass the AbilityQ test (Turner-Stokes 2003) that assesses the cognitive ability to fill in a rating scale for pain.
Who cannot join
- Exclusion criteria comprise any other disorder with an impact on sensorimotor function, any other severe concomitant disease (such as cancer, cardiovascular, inflammatory or psychiatric disease), uncontrolled epilepsy or blood pressure, major surgery during the last year, any implanted medical devices, pregnancy, BMI>35.
- Patients with ongoing pharmacological treatment for spasticity or pain may be included only if the medication is stable since at least 3 months. Patients, who have been subject to intramuscular treatment for spasticity may participate only if the time since last treatment is 3 months or more and if it is anticipated that next treatment will not be given during the study period.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, SE18288
Susanne Palmcrantz, PhD, +46 (0)70-9567653, susanne.palmcrantz@ki.se
Jorgen Borg, Prof, +46 (0)70-1684213, jorgen.borg@ki.se
About this study
In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a Swedish Med-tech company. Based on theoretical background and clinical experience, this study will explore the potential value of the EXOPULSE Mollii suit-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
Read the detailed description
One challenging complication to stroke is the development of hemiplegic shoulder pain, which is reported in approximately 30% of the stroke population. Treatment strategies recommended in the Swedish National Guidelines for Stroke Care (NBHW) include use of assistive devices for arm support and treatment with transcutaneous electric nerve stimulation (TENS), which may impact on both pain and muscle tone. In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a small Swedish med-tech company. The suit ( EXOPULSE Mollii suit) is currently used for treatment of disabling spasticity and to improve motor function in persons living with effects of central nervous system disease or injury. The theoretical background of the EXOPULSE Mollii-method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of EXOPULSE Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition. Studies on the effects on spasticity and perceived usability of the suit in a stroke population have recently been completed by our study group at the Department of Rehabilitation Medicine Stockholm at Danderyd Hospital (dnr 2017/935-31) and preliminary analyses indicate that spasticity may be reduced by use of the suit.
Based on the theoretical and practical background outlined above, this study will explore the potential value of the Mollii-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
- Conditions
- Stroke, Pain, Shoulder, Technology, Therapeutics
- Being tested
- EXOPULSE Mollii suit
- Medical subject headings
- Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii suitDevice
All sessions start with rated perceived pain with the NRS and the ShoulderQ questionnaire and assessed body function with the Fugl-Meyer UE scale, Ashworth scale and the Neuroflexor, before the start of the intervention.
Session 1. Stimulation with TENS according to best clinical practice. Session 2. Stimulation with the Mollii suit according to current best experienced practice with selective stimulation directed to the shoulder region Session 3. Stimulation using the full body Mollii suit according to current best experienced practice.
Outcome of each session is assessed with a pain drawing, the NRS (during and after treatment) and the Fugl-Meyer UE, Ashworth scale and the Neuroflexor (after treatment).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3 sessions with 3 different interventions 1) Transcutaneous electric nerve stimulation (TENS)- at the shoulder according to current best evidence and practice 2) EXOPULSE Mollii suits- local stimulation at the shoulder, 3) EXOPULSE Mollii suit- according to current best experienced practice
The order in which the participants´ receive the different treatments will be randomized.
Each session lasts for approximately 2.5 hours (approximately 60 min for assessment, 30 min for settings and adjustments and 60 min for treatment) Receives: Device: EXOPULSE Mollii suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Pain rating on a 10-point scale
Measured: 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour).
Pain drawing
Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions)
Measured: 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour).
Secondary outcomes (6)
Fugl-Meyer score for the upper extremity
Assessed Motor and sensory function of the upper extremity after stroke max range 0-126 p
Measured: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
Ashworth scale
Clinical assessment of spasticity on a 5 point scale
Measured: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
Neuroflexor
Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton)
Measured: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
ShoulderQ questionnaire
Perceived pain and discomfort in activities of daily living rated as standardized statements and on a numeric rating scale
Measured: Before each treatment session (within 2 hours before the start of the treatment session)
Pain diary
The pain diary will include ratings of shoulder pain at night, at rest and during movement according to the ShoulderQ questionnaire (rated on a numeric rating scale)
Measured: The Pain diary is filled in daily, during the week before the first treatment session and daily during the week between treatment sessions.
Stroke Impact Scale
Overall perceived level of functioning
Measured: Once, before the start of the first session (within 2 hours of the first treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start9 Aug 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Explorative study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Palmcrantz, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632186
- Sponsor's protocol ID
- Mollii Pain Study
- Status last verified
- Aug 2021
- First submitted
- 10 Nov 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
PubMed 21430513Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.
PubMed 17185637Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
PubMed 32778118DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.
PubMed 19007541
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Electronic Suit to Reduce Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT04632186
- Acronym / sponsor ID
- Mollii Pain Study
- Conditions
- Stroke, Pain, Shoulder, Technology, Therapeutics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 9 Aug 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 17 Nov 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.
In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a Swedish Med-tech company. Based on theoretical background and clinical experience, this study will explore the potential value of the EXOPULSE Mollii suit-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
Detailed description
One challenging complication to stroke is the development of hemiplegic shoulder pain, which is reported in approximately 30% of the stroke population. Treatment strategies recommended in the Swedish National Guidelines for Stroke Care (NBHW) include use of assistive devices for arm support and treatment with transcutaneous electric nerve stimulation (TENS), which may impact on both pain and muscle tone. In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a small Swedish med-tech company. The suit ( EXOPULSE Mollii suit) is currently used for treatment of disabling spasticity and to improve motor function in persons living with effects of central nervous system disease or injury. The theoretical background of the EXOPULSE Mollii-method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of EXOPULSE Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition. Studies on the effects on spasticity and perceived usability of the suit in a stroke population have recently been completed by our study group at the Department of Rehabilitation Medicine Stockholm at Danderyd Hospital (dnr 2017/935-31) and preliminary analyses indicate that spasticity may be reduced by use of the suit.
Based on the theoretical and practical background outlined above, this study will explore the potential value of the Mollii-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explorative study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: EXOPULSE Mollii suit3 sessions with 3 different interventions 1) Transcutaneous electric nerve stimulation (TENS)- at the shoulder according to current best evidence and practice 2) EXOPULSE Mollii suits- local stimulation at the shoulder, 3) EXOPULSE Mollii suit- according to current best experienced practice The order in which the participants´ receive the different treatments will be randomized. Each session lasts for approximately 2.5 hours (approximately 60 min for assessment, 30 min for settings and adjustments and 60 min for treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will have suffered a stroke > 6 months earlier and are living with hemiplegia affecting the right or the left side of the body including the upper extremity. They will have developed hemiplegic shoulder pain within the first 6 months after stroke onset. Moreover, eligible study participants will be able to understand instructions as well as written and oral study information and can express informed consent. Furthermore, study participants need to pass the AbilityQ test (Turner-Stokes 2003) that assesses the cognitive ability to fill in a rating scale for pain.
Key exclusion criteria (2 listed)
- Exclusion criteria comprise any other disorder with an impact on sensorimotor function, any other severe concomitant disease (such as cancer, cardiovascular, inflammatory or psychiatric disease), uncontrolled epilepsy or blood pressure, major surgery during the last year, any implanted medical devices, pregnancy, BMI>35.
- Patients with ongoing pharmacological treatment for spasticity or pain may be included only if the medication is stable since at least 3 months. Patients, who have been subject to intramuscular treatment for spasticity may participate only if the time since last treatment is 3 months or more and if it is anticipated that next treatment will not be given during the study period.
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 |
|---|---|---|
| EXOPULSE Mollii suitAll sessions start with rated perceived pain with the NRS and the ShoulderQ questionnaire and assessed body function with the Fugl-Meyer UE scale, Ashworth scale and the Neuroflexor, before the start of the intervention. Session 1. Stimulation with TENS according to best clinical practice. Session 2. Stimulation with the Mollii suit according to current best experienced practice with selective stimulation directed to the shoulder region Session 3. Stimulation using the full body Mollii suit according to current best experienced practice. Outcome of each session is assessed with a pain drawing, the NRS (during and after treatment) and the Fugl-Meyer UE, Ashworth scale and the Neuroflexor (after treatment). | Device | Intervention |
Primary outcome
Numerical rating scale
Time frame: 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour).
Pain rating on a 10-point scale
Pain drawing
Time frame: 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour).
Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions)
6 secondary outcomes
Fugl-Meyer score for the upper extremity
Time frame: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
Ashworth scale
Time frame: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
Neuroflexor
Time frame: 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).
ShoulderQ questionnaire
Time frame: Before each treatment session (within 2 hours before the start of the treatment session)
Pain diary
Time frame: The Pain diary is filled in daily, during the week before the first treatment session and daily during the week between treatment sessions.
Stroke Impact Scale
Time frame: Once, before the start of the first session (within 2 hours of the first treatment session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 21430513Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.
- Background: PubMed 17185637Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.
- Background: PubMed 32778118Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.
- Background: PubMed 19007541DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.
- 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.
Susanne Palmcrantz, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii suit in people with Stroke and Pain, Shoulder, run by Danderyd Hospital at 1 site in Sweden.
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 2 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 31 Aug 2021. 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 Sweden. 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?
Contact Susanne Palmcrantz, PhD (+46709567653, susanne.palmcrantz@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour).). The study lists 2 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 NCT04632186, which also lists 4 linked publications.
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 31 Aug 2021.