NCT04632186

Development of an Electronic Suit to Reduce Hemiplegic Shoulder Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Stroke
• Pain, Shoulder
• Technology
• Therapeutics

Interventions

Type	Name	Description
DEVICE	EXOPULSE Mollii suit	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).

Timeline

• Start date: 2020-08-09
• Primary completion: 2022-08-31
• Completion: 2022-12-30
• First posted: 2020-11-17
• Last updated: 2021-08-31

Locations

1 site across 1 country: Sweden