Stroke Clinical Trial
Official title:
Development of an Electronic Suit to Reduce Hemiplegic Shoulder Pain
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 30, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Rehabilitation Medicine, Danderyd Hospital | Danderyd | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Danderyd Hospital |
Sweden,
DeSantana 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. Review. — View Citation
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. Review. — View Citation
Lindgren I, Jönsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. Epub 2006 Dec 21. — View Citation
Palmcrantz 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical rating scale | Pain rating on a 10-point scale | 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). | |
Primary | Pain drawing | Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions) | 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 | Fugl-Meyer score for the upper extremity | Assessed Motor and sensory function of the upper extremity after stroke max range 0-126 p | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | |
Secondary | Ashworth scale | Clinical assessment of spasticity on a 5 point scale | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | |
Secondary | Neuroflexor | Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton) | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | |
Secondary | ShoulderQ questionnaire | Perceived pain and discomfort in activities of daily living rated as standardized statements and on a numeric rating scale | Before each treatment session (within 2 hours before the start of the treatment session) | |
Secondary | 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) | The Pain diary is filled in daily, during the week before the first treatment session and daily during the week between treatment sessions. | |
Secondary | Stroke Impact Scale | Overall perceived level of functioning | Once, before the start of the first session (within 2 hours of the first treatment session) |
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