Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
ID06109129

Investigation Of The Effectiveness Of The Mollii Suit In Children With Ambulatory Cerebral Palsy: A Double-Blind Randomized Controlled Study

Led by Kastamonu University · Updated on 2025-07-11

32

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kastamonu University

Lead Sponsor

G

Gazi University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cerebral Palsy (CP) is a common developmental disorder in childhood that affects movement and posture due to brain damage. It often restricts independence in daily activities, education, social participation, and may involve challenges like pain, spasticity, and sleep issues. This research explores the EXOPULSE Mollii Suit, a new rehabilitation technology designed to improve motor function by reducing spasticity and pain through electrical stimulation of muscles in children with ambulatory spastic CP. The study compares two groups: one using the Mollii Suit for 60 minutes, three days a week, which is a full-body garment that sends low-frequency electrical signals to reduce muscle spasticity; and a control group continuing routine pediatric physiotherapy three days a week, including exercises like stair climbing, walking, balance, strengthening, and flexibility. The intervention sessions involve the child wearing the suit while sitting or lying down to ensure effectiveness. Participants will be assessed through various measures including the Edinburgh Visual Gait Score to evaluate walking, and other tests assessing motor function, spasticity, balance, postural control, daily activities, quality of life, pain, and sleep quality. The study uses questionnaires, physical tests, and scales over several visits. Researchers will monitor these outcomes to understand how the Mollii Suit impacts children with CP over the course of the study, which runs until November 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being a voluntary participant in the study
  • Having a diagnosis of spastic cerebral palsy
  • Being classified between levels 1 and 3 on the Gross Motor Classification System (GMFCS)
  • Being between 4 and 18 years old
  • Being able to express pain and discomfort
Not Eligible

You will not qualify if you...

  • Being classified between levels 4 and 5 on the Gross Motor Classification System (GMFCS)
  • Having had Botulinum Toxin A treatment within the past 3 months
  • Having had surgical intervention within the past 6 months
  • Having a shunt or an invasive medical pump (e.g., baclofen, insulin)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Not specified

Participants in the intervention group will wear the Mollii Suit for 60 minutes, 3 days a week, during which they will sit or lie down. Participants in the control group will continue their routine pediatric physiotherapy program 3 days a week.

3 visits per week

Trial Site Locations

Total: 1 location

1

Gazi University

Ankara, Turkey (Türkiye)

Actively Recruiting

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Research Team

H

Hidayet Cuha, PHD Candidate

M

Merve Ozturk, PHD Student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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