Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— EXOCEP2GER  

Official title:

The Effects of EXOPULSE Mollii Suit on Motor Functions in Children With Cerebral Palsy (EXOCEP 2 GER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885139
• Other study ID #: PS00011278C-001
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Exoneural Network AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

Description:

Cerebral Palsy is a heterogenous group of disorders that was first introduced in the literature in 1843 by Little who described musculoskeletal deformities and spastic limbs in the context of neonatal hypoxia. The clinical classification of CP could be based on several system. For instance, the classification by Balf and Ingram takes into account the type, lesion location and severity of the clinical symptoms, and entails the following CP types that could be further considered as mild, moderate or severe: diplegia, hemiplegia or tetraplegia with the presence of spastic syndromes, dyskinetic syndromes and ataxia. In the context of CP, spasticity is a frequent and debilitating symptom that could occur in 70-89% of individuals. Spasticity could subsequently alter the development of motricity, quality of life, patients' self-es-teem and seems to be associated with several health consequences, namely pain, infections, joint deformities, thrombosis and bedsores. Managing spasticity in CP include the combination of pharmacotherapy, motor rehabilitation, and surgical interventions. It is now widely accepted that spasticity impacts balance and mobility, halts the patients quality of life (e.g., urinary symptoms, sexual dysfunction, mood symptoms, low self-esteem) and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. The available interventions targeting spasticity are faced with some limitations. For instance, botulinum toxin injection does not seem to improve motor functions and quality of life as well as available oral agents are challenged by their potential side effects. Therefore, developing novel therapies would help to overcome the actual limitations. Transcutaneous Electrical Nerve Stimulation (TENS) has proven some efficacy in spasticity management. However, one should note that practical difficulties could arise when using TENS at home or in clinical practice (i.e., correctly attaching electrodes). To overcome these limitations, the Exopulse Mollii Suit has been developed by Exoneural Network AB (initially Inerventions AB), a Swedish medtech company. It represents an innovative approach for non-invasive electrostimulation to reduce spasticity and improve motor function. Based on the theoretical and practical background outlined above, this study will explore the potential clinical benefits of the Mollii-method in children with cerebral palsy. The overall aim of this study is to evaluate the short-term impact of Exopulse Mollii Suit on balance in pediatric patients with cerebral palsy who are suffering from spasticity as well as assessing the effects of Exopulse Mollii Suit on spasticity, mobility, pain, and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

Patients will be included if they

• are between 5 and 12 years of age.
• have a clinical diagnosis of unilateraal or bilateral spastic CP by birth [15].
• have a PBS score between a minimum of 15 and a maxmimum of 44 points.
• are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score =3) [49].
• are German speakers, able to understand verbal instructions.
• have spasticity with a score of at least 1+ on the MAS Exclusion Criteria: Patients will not be included if they
• are included in another research protocol during the study period.
• are unable to undergo clinical procedures for the study purposes due to geographical or social reasons.
• have a cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump.
• have a change in their pharmacological therapy over the last three months or are planning to do so during the study.
• suffer from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
• have a body mass index above 35 kg/m2,
• have contraindications to wearing Exopulse Mollii Suit, receive a medical device other than Exopulse Mollii during the study period.
• have received botulinum toxin (botox) therapy in the last 3 months before the start of the study

Related Conditions & MeSH terms

• Balance
• Cerebral Palsy
• Diplegia
• Hemiplegia
• Muscle
• Muscle Spasticity
• Pain Syndrome
• Quadriplegia
• Spasticity
• Tetraplegia

Intervention

Device:
• Exopulse Mollii Suit
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
• Sham Exopulse Mollii Suit
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover (MHH)	Hanover
Germany	Pohlig GmbH	Traunstein	Bavaria

Sponsors (4)

Lead Sponsor	Collaborator
Exoneural Network AB	Hannover Medical School, Ottobock SE & Co. KGaA, Pohlig GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Diary	4. Patient Diary A patient diary is provided to patiets to record information during the 14-day homeuse phase. If the child is not able to do this him/herself, the parent or cargicer can support this process. The use of the Exopulse Mollii Suit should be recorded, whether the stimulation duration of 1 hour is adhered every day. In addition, comfort/satisfaction, pain/discomfort and possible incidents such as mild adverse events should be documented.	Visit 1; Visit 2 = 2 weeks after visit 1; Visit 3 = 4 weeks after visit 1. Visit 4 = 6 weeks after visit 1
Other	Blinding Questionnaire	Evaluation of patient's blinding to the type of stimulation will be performed by asking for their perception which treatment they received: "(a) Treatment/ (b) Placebo/ (c) I don' know" and "if (c) I don't know" which they would by chance choose "(a) Treatment/ (b) Placebo.	Visit 2 = 2 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Other	Changes in Functional Gait Assessment (FGA)	(optional)	Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1. ; Visit 4 = 6 weeks after visit 1
Primary	Changes in Pediatric Balance Scale (PBS)	Pediatric patients with CP, the PBS has a minimum detectable change (MDC) of 1.59 for the total score and 0.79 (static) and 0.96 (dynamic) for the subscores. Furthermore, the PBS has a minimally clinically important difference (MCID) for the cohort mentioned of 5.83 for the otal score and 2.92 (static) and 2.92 (dynamic) for the subscores.	Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Secondary	Changes in Modified Ashworth Scale (MAS)	The modified Ashworth Scale measures spasticity in patients with lesions of the Central Nervous System. It tests resistance to passive movement in a joint with varying degrees of velocity. Scores range from 0-4 with 5 choices. A score of 1 indicates no resistance, and a 5 indicates rigidity.	Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1
Secondary	Changes in Timed Up and Go (TUG)	In the chair with his/her back against the chair back. On the command "go", the patient rises from the chair, walks 3Visit 1 = Immediately before and after first 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = 4 weeks after visit 1. Immediately before and after first 1h stimulation; Visit 4 = 6 weeks after visit 1 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated.	Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1