Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Examining the Efficacy of Mollii Suit in Children With Non-Ambule Cerebral Palsy: A Single Blind Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259864
• Other study ID #: CerebralPalyMolliiSuit
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Kirikkale University
• Contact: Kübra Ugurlu
• Phone: +905077295353
• Email: kubra.ozdamar06[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).

Description:

Our study includes children diagnosed with spastic type cerebral palsy at GMFCS level 4 or 5 who applied to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into two groups by simple randomization method. Evaluations will be made before and after treatment. In addition to normal neurodevelopmental therapy (NGT) and Mollii Suit method will be applied 2 days a week. The total duration of treatment will take 8 weeks. Groups; The first group will consist of children with CP who will receive neurodevelopmental treatment. The second group will consist of children who will receive the Molli Suit method in addition to neurodevelopmental treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• GMFCS 4 or 5 with spastic cerebral palsy children
• Volunteering to participate in the study

Exclusion Criteria:

• Botulinum toxinA injection in the last 3 months
• Surgical intervention involving the musculoskeletal system in the last 6 months
• Having an invasive medical pump (baclofen, insulin, etc.)

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• EXOPULSE Mollii Suit method
EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Kirikkale University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 — View Citation

Flodstrom C, Viklund Axelsson SA, Nordstrom B. A pilot study of the impact of the electro-suit Mollii(R) on body functions, activity, and participation in children with cerebral palsy. Assist Technol. 2022 Jul 4;34(4):411-417. doi: 10.1080/10400435.2020.1 — View Citation

Pennati GV, Bergling H, Carment L, Borg J, Lindberg PG, Palmcrantz S. Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity. Front Neurol. 2021 Oct 15;12:706610. doi: 10.3389/fneur.2021.706610. eCollection 202 — View Citation

Perpetuini D, Russo EF, Cardone D, Palmieri R, De Giacomo A, Pellegrino R, Merla A, Calabro RS, Filoni S. Use and Effectiveness of Electrosuit in Neurological Disorders: A Systematic Review with Clinical Implications. Bioengineering (Basel). 2023 Jun 2;10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure	GMFM evaluates children's motor activities in 5 different positions called 'lying down and rolling over', 'crawling and kneeling down', 'sitting', 'standing' and 'walking, running, jumping' on a scale of 0-3 (0: unable to initiate movement. 3: independent movement). It is a measurement method that scores.	15 minutes
Primary	Modified Tradiue Scale	Modified Tardiue Scale (MTS) will be used in the evaluation of spasticity. MTS is a method that evaluates the velocity-sensitive nature of spasticity through passive movement. Muscle tone of the ankle plantar flexors will be assessed in both knee flexion and extension. Hamstring spasticity will be tested in the supine position with the pelvic-femoral angle at 90°. After slow and fast stretching of the joint, two values of the angle will be measured according to angle R2 and R1 respectively. R1 is defined as the point in the PEHA at which a catch or clonus is first felt during rapid stretching of the joint, while R2 is defined as the total PEHA of the ankle. R2-R1 represents the dynamic component of spasticity. Spasticity will be measured according to the muscle reaction when stretching as fast as possible and will be graded from 0 to 5.	5-10 minutes
Primary	Modified Ashworth Scale	Modified Ashworth Scale (MAS) will be used to evaluate muscle tone. Hamstring and plantar flexor muscle tone evaluation will begin in the supine position, with the head in the midline and the extremities in the resting position, and MAS scores will be determined between 0-4 according to the resistance level of the antagonist muscles during passive movement.	5 minutes
Primary	Functional Reach Test	Functional Reach Test (FRT) will be used to measure trunk stability during reaching. The amount of lateral stretching will be measured from the tip of the 3rd metacarpal bone in a sitting position and at the edge of the wall.	3 minutes
Primary	Trunk Impact Scale	Trunk Impact Scale (TIS) will be used to functionally evaluate the trunk in the sitting position. It has three subsections: static and dynamic sitting balance and coordination.	5 minutes
Primary	Quality of Upper Extremity Skills Test	The Quality of Upper Extremity Skills Test (QUEST) will be used to evaluate the quality of upper extremity skills. The test is a criterion-referenced observational evaluation test consisting of 34 items. It consists of four subsections: "discrete movement", "grip", "weight transfer" and "protective extension". In the heterogeneous movements section of QUEST; The active joint movements of the child's upper extremity are observed one by one and scored according to the items. In the grip section; Functions such as grasping a cube, holding a pencil, grasping a chickpea are evaluated. In the weight transfer section, the child is asked to transfer weight to the front, side and back with his upper extremities while sitting. In the protective extension section, the protective extension reaction of the child forward, sideways and backward in response to a sudden push in a certain direction while the child is sitting is examined.	10 minutes
Primary	Constipation Assessment Scale	The Constipation Assessment Scale (CAS) will be used to evaluate children's constipation status. This scale evaluates the presence and severity of constipation in children and adults. This scale, consisting of nine questions, is a valid and reliable tool.	2 minutes
Primary	Functional Independence Measure for Children	Children's functional independence assessments The Functional Independence Measure for Children (WeeFIM) will be used. WeeFIM is a modified version of the Functional Independence Measure (FIM), which was developed for adults, for children. It consists of 6 subheadings, including self-care, sphincter control, transfer, movement, communication and social status, and a total of 18 questions. Scoring is made between 1-7, with a high score defining a good level of functional independence.	3 minutes
Secondary	Cerebral Palsy Quality of Life Questionnaire	The Cerebral Palsy Quality of Life Questionnaire will be used for health-related quality of life assessment. This questionnaire is a scale consisting of child and parent items in 7 areas such as "feelings about function", "participation and physical health".	10 minutes
Secondary	Selective Control Assessment of the Lower Extremity.	Selective Control Assessment of the Lower Extremity (SCALE) will be used to evaluate individuals' lower extremity selective motor control. It is a valid and reliable method in which selective control of lower extremity joint movements is scored between 0-2 points.	5 minutes
Secondary	Test of Arm Selective Control	Test of Arm Selective Control (TASC), developed by Sukal-Moulton et al. in 2017, was used to evaluate children's upper extremity selective motor control. Each movement was scored as 0 (absent), 1 (affected) or 2 (normal) according to descriptive subparameters.	5 minutes
Secondary	Drooling Impact Scale	he Drooling Impact Scale was completed by the same rater on two occasions, 1 month apart, to assess the impact of drooling in children who were expected to be stable. The scale has been shown to behave as expected in validity studies, to have good test-retest reliability in stable children, and to be responsive to change in children who have undergone saliva-control interventions	3 minutes
Secondary	Pittsburgh Sleep Quality Index	It is an index consisting of a total of 24 items that evaluate subsections such as sleep quality and duration.	5 minutes