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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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).
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm County, Sweden
RECRUITINGNumerical rating scale
Pain rating on a 10-point 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 drawing
Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions)
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).
Fugl-Meyer score for the upper extremity
Assessed Motor and sensory function of the upper extremity after stroke max range 0-126 p
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
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
Overall perceived level of functioning
Time frame: Once, before the start of the first session (within 2 hours of the first treatment session)
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