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

NCT06259864 | Recruiting

• 1 other identifier: CerebralPalyMolliiSuit
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mollii Suit; Cerebral Palsy

Keywords

cerebral palsy; mollii suit; spasticity; salivation; constipation; gross motor function; quality of life

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Cerebral Palsy Quality of Life Questionnaire

  10 minutes

• Selective Control Assessment of the Lower Extremity.

  5 minutes

• Test of Arm Selective Control

  5 minutes

• Drooling Impact Scale

  3 minutes

• Pittsburgh Sleep Quality Index

  5 minutes

Study Arms (2)

Neurodevelopmental treatment program group

ACTIVE COMPARATOR

NDT aims to bring the child to the maximum level of independence possible within the limits of age and ability. Treatment sessions are planned for a certain functional result, and the patient's active participation as much as possible is requested. As the child fulfills postural and motor requirements, the physical therapist provides less assistance and less guidance. Positionings supported by auxiliary materials, appropriate hand contacts, correct ways to hold the child, tonus regulation, family education, environmental regulations and goal-oriented quality movement approaches; These are some of the methods used by the NDT approach, which is based on facilitation, stimulation and communication. Neurodevelopmental treatment physiotherapy session for 2 days in a week, over 8 week.

Other: EXOPULSE Mollii Suit method

Mollii Suit method group

EXPERIMENTAL

The Exopulse Mollii Suit is designed to restore normality and healthy balance of muscle groups in the body. The suite uses one of several different forms of neuromodulation, based on gently stimulating the affected muscle groups with electrical signals. This approach has been shown to help resynchronize muscle signals that have been disrupted due to spasticity and muscle groups that may have stopped working together. 58 electrodes embedded in the suit send mild and imperceptible impulses to both tense and spastic muscles and the weakened muscles that balance them. These stimulations not only relax tense muscles and reactivate weak ones, but also restore the natural balance of the group and help the body move as it should. Children will wear the outfit twice a week for 8 weeks and each session will last 60 minutes. During this practice, children will also receive NDT twice a week.

Other: EXOPULSE Mollii Suit method

Interventions

EXOPULSE Mollii Suit method OTHER

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.

Mollii Suit method group; Neurodevelopmental treatment program group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Kırıkkale University: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 2021.

  PMID: 34721255 RESULT

• 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: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.

  PMID: 33151822 RESULT

• 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(6):680. doi: 10.3390/bioengineering10060680.

  PMID: 37370612 RESULT

• 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 Jul 20.

  PMID: 30061001 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Sialorrhea; Constipation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive

Study Officials

• Bülent Elbasan

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Kübra Uğurlu

CONTACT

+905077295353; kubra.ozdamar06@gmail.com

Bülent Elbasan

CONTACT

bulentelbasan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 14, 2024
• Study Start: January 20, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)