Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy

NCT06109129 | Recruiting DMC

• 1 other identifier: 2023 - 1137
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. 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. Therefore, the aim of our study is to examine the effectiveness of the Mollii Suit application on gross and fine motor function, spasticity severity, balance, walking, selective motor control, postural control, daily living activities, quality of life, pain and sleep quality in individuals with ambulatory spastic CP.

Conditions

Cerebral Palsy; Spasticity, Muscle

Keywords

Cerebral Palsy; Rehabilitation Technology; Spasticity; Electrotherapy

Outcome Measures

Primary Outcomes (1)

• The Edinburgh Visual Gait Score (EVGS)

  Set up one of the cameras at the end of the 8m walkway track line to capture a coronal view. Place the second camera facing the center of the walkway to capture the sagittal view. The second camera should be set far enough away so as to capture the middle four meters of each trial. A patient should be able to complete two full strides in this distance. Adjust the cameras to be level with the height of the patient's greater trochanter. Record the patient walking back and forth along the walkway. The patient should be barefoot. Open the video recordings in any video player software and take screenshots of each gait cycle event from both coronal and sagittal views. There are 17 observational parameters that should be measured. Each parameter is scored based on either observed condition or measured joint angles. A three-point scale is used for each parameter. After scores have been assigned for each parameter, all scores should be summed.

  10-15 minutes

Secondary Outcomes (10)

• The Gross Motor Function Measure (GMFM)

  45-60 minutes

• Tardieu Scale

  10-15 minutes

• Trunk Control Measurement Scale (TCMS)

  15-20 minutes

• Modified Timed Up and Go Test

  3-5 minutes

• Modified Functional Reach Test

  3-5 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

First group will participate in the Mollii Suit application for 60 minutes 3 days a week. Mollii Suit consists of a pair of trousers and a jacket. It is a neuromodulation garment consisting of a non-invasive removable control unit that sends electrical signals to the user through electrodes inside. The child will wear the Molli Suit when he/she comes to each session, and the child will be asked to sit or lie down throughout the application in order to avoid any interference with the effectiveness of the suit.

Device: EXOPULSE Mollii Suit

Control Group

NO INTERVENTION

The control group will continue the routine pediatric physiotherapy program 3 days a week. This program, which includes exercises appropriate to the child's motor function level, includes stair climbing, walking exercises, balance, strengthening and flexibility exercises.

Interventions

EXOPULSE Mollii Suit DEVICE

EXOPULSE Mollii Suit is a personal assistive medical device which is used for low energy whole body transcutaneous electrical stimulation - 20 Volt and 20 Hz. It is composed of a control unit, a jacket and pants with 58 embedded electrodes in direct contact with the skin. EXOPULSE Mollii Suit is used for activation of muscles or relaxation of spastic muscles mediated by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical signal to an antagonistic muscle, the spastic muscle may subsequently relax.

Intervention Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being a voluntary participant in the study,
• Having a diagnosis of spastic CP,
• Being between 1-3 on the Gross Motor Classification System (GMFCS),
• Being between the ages of 4 and 18,
• Being able to express pain and discomfort

You may not qualify if:

• Being between 4-5 on Gross Motor Classification System (GMFCS)
• Having Botolunim Toxin A application before 3 months
• Having a surgical intervention before 6 months
• Having a shunt or an invasive medical pump (baclofen, insulin, etc.)

Sponsors & Collaborators

• Kastamonu University: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

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

Central Study Contacts

Hidayet Cuha, PHD Candidate

CONTACT

+90 534 646 01 06; hcuha@kastamonu.edu.tr

Merve Ozturk, PHD Student

CONTACT

+90 543 426 40 93; oozturkmerve@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All assessments will be performed by an experienced pediatric physiotherapist blinded to the study hypothesis and design. Statistical analysis of the study will be performed by a biostatistician blinded to the study hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (PHd student)

Model Details: A Double-Blınd Randomızed Controlled Study

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: November 5, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

TU (1)