Clinical trial NCT05408806: Technology Assisted Rehabilitation in CP
Official title: The Effect of Technology Assisted Rehabilitation Interventions on Postural Control, Activity and Participation in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: cerebral palsy
postural control
rehabilitation
virtual reality games
hippotherapy simulator
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children between the ages of 5 and 18 who have been diagnosed with spastic cerebral palsy constitute the population of the study.

Brief summary: The aim of the research is to increase the active participation of children with Cerebral Palsy (CP) in therapy by integrating technological approaches into rehabilitation; To examine the effects of Nintendo Wii virtual reality games or hippotherapy simulator use on postural control, activity and participation in addition to Neurodevelopmental Therapy (NGT), which is frequently used in rehabilitation programs in CP, and to contribute to the relevant literature.

H1/H1-0: In the rehabilitation of children with Cerebral Palsy, Nintendo Wii virtual reality games in addition to NGT has or has no effect on postural control, lower extremity selective motor control, spasticity, activity and participation levels.

H2/H2-0: In the rehabilitation of children with Cerebral Palsy, Hippotherapy simulator in addition to NGT has or has no effect on postural control, lower extremity selective motor control, spasticity, activity and participation levels.

Detailed description: Cerebral Palsy (CP) defines a group of permanent disorders in the development of movement and posture, which occur in the developing fetal and newborn brain, due to non-progressive disorders, leading to activity limitations. The most common clinical type in CP is the spastic type, which is characterized by an increase in muscle tone. The deficiencies in the development of balance and protective reactions seen in children with spastic type CP, combined reactions and stereotypical movement patterns form the basis of postural control dysfunction. Postural control disorder results from primary brain injury that causes deficiencies in postural networks. motor networks; affected by spasticity, contracture, decreased force production, and abnormal timing; Perceptual networks are affected by deficiencies in the visual, tactile, proprioceptive, and vestibular systems. It is known to cause limitations during upper extremity activities, especially in gross motor skills that require balance such as walking.

Neurodevelopmental therapy (NGT); It is the most widely used method in CP rehabilitation all over the world, aiming to optimize function by improving postural control and facilitating the thought of movement. In a recent systematic review, the effects of treatment approaches in children with CP were examined and it was shown that technology-supported exercise training has a high level of evidence in improving gross motor functions. There are studies emphasizing that Nintendo Wii virtual reality games and hippotherapy simulator improve postural control and dynamic balance in children with CP.

Nintendo Wii virtual reality games and hippotherapy simulator are used as technology supported rehabilitation applications in addition to NGT in the research. Using both methods; In CP rehabilitation, the effects on the development of postural control, selective motor movement, spasticity level and, accordingly, activity and participation levels will be examined and contributed to the literature.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with spastic type CP,
* Being between the ages of 5-18,
* In Gross Motor Function Classification System (KMFSS); Taking place at I-II-III level,
* The family and the child agreed to participate in the study after reading the informed consent form.

Exclusion Criteria:

* Botulinum Toxin (BOTOX) injection to the lower extremity in the last 6 months,
* Having a diagnosis of epilepsy
* Having been diagnosed with mental retardation,
* Receiving additional treatment other than neurodevelopmental treatment,
* Having a vision and/or hearing problem that may affect participation in treatment methods.

Primary outcomes:
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: Baseline and after 8 weeks
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: Baseline and after 8 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline and after 8 weeks
measure: BeCure Balance Assessment System
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: Baseline and after 8 weeks
measure: Pediatric Quality of Life Inventory™ (PedsQL) 3.0 CP Module
timeFrame: Baseline and after 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Yonca Zenginler Yazgan, Asst.Prof.
role: STUDY_DIRECTOR
References: