The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes

Stroke Clinical Trial

Official title: The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes

Status Not yet recruiting

Clinical Trial Summary

The objective is to explore the potential short and long-term impact of the Exopulse Mollii Suit on subjects with CP, MS, stroke, SCI or other neurological disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvement on the Berg/Pediatric Balance Scale (BBS) as a measurement of balance and risk of falls.

Clinical Trial Description

The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement and relaxation of muscles, muscle activation, local blood circulation and chronic pain relief.

The subjects will serve as their own control and the data will be collected before, during and after the treatment period. As the electrical stimulation from the suit usually is above the level of sensation, the study participant cannot be blinded to the treatment.

To prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. All investigators will be trained on the measurements prior to the registry start.

Additionally, all investigators are trained and certified in the Exopulse method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment.

Re-assessments during scheduled visits are part of normal routine and use. The decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Multiple Sclerosis
• Nervous System Diseases
• Neurologic Disorder
• Spinal Cord Injuries
• Stroke

• NCT number: NCT05901259
• Study type: Observational [Patient Registry]
• Source: Exoneural Network AB
• Contact: Mimi Westerlund, Phd
• Phone: +46-(0)707 62 99 41
• Email: Mimi.Westerlund@exopulse.com
• Status: Not yet recruiting
• Start date: August 1, 2024
• Completion date: December 31, 2027