Clinical trial NCT06259864: Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy
Official title: Examining the Efficacy of Mollii Suit in Children With Non-Ambule Cerebral Palsy: A Single Blind Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mollii Suit
Cerebral Palsy
Keywords: cerebral palsy
mollii suit
spasticity
salivation
constipation
gross motor function
quality of life
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Gross Motor Function Measure
timeFrame: 15 minutes
measure: Modified Tradiue Scale
timeFrame: 5-10 minutes
measure: Modified Ashworth Scale
timeFrame: 5 minutes
measure: Functional Reach Test
timeFrame: 3 minutes
measure: Trunk Impact Scale
timeFrame: 5 minutes
measure: Quality of Upper Extremity Skills Test
timeFrame: 10 minutes
measure: Constipation Assessment Scale
timeFrame: 2 minutes
measure: Functional Independence Measure for Children
timeFrame: 3 minutes
Secondary outcomes:
measure: Cerebral Palsy Quality of Life Questionnaire
timeFrame: 10 minutes
measure: Selective Control Assessment of the Lower Extremity.
timeFrame: 5 minutes
measure: Test of Arm Selective Control
timeFrame: 5 minutes
measure: Drooling Impact Scale
timeFrame: 3 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Bülent Elbasan
role: STUDY_DIRECTOR
References:
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 2021.
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: 10.1080/10400435.2020.1837288. Epub 2021 Mar 29.
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(6):680. doi: 10.3390/bioengineering10060680.
citation: 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.