Technology Assisted Rehabilitation in CP

NCT ID: NCT05408806

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-31

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.

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Virtual Reality Games Group with Nintendo Wii Balance Platform

In addition to neurodevelopmental treatment, the cases are treated with virtual reality (VR) games on nintendo wii balance board for 8 weeks, 2 sessions a week. The VR games are performed twice in the first four weeks at the beginner level. During the following four weeks, advanced levels of the same games are selected and virtual reality therapy is performed with 2 repetitions.

Exercise Interventions

Intervention Type: OTHER

Rehabilitation methods and exercise practices to improve postural control in children with cerebral palsy. In addition to neurodevelopmental treatment, one group is treated with virtual reality games and the other group is treated with a hippotherapy simulator.

Hippotherapy Simulator Group

In addition to neurodevelopmental treatment, the cases are treated on a hippotherapy simulator for 8 weeks, 2 sessions a week. In the first 4 weeks, the warm-up and 1 speed intensities of the hippotherapy simulator are applied. During the next 4 weeks, cases are treated warm-up, 1, 2, 3, speed intensities, respectively.

Exercise Interventions

Intervention Type: OTHER

Rehabilitation methods and exercise practices to improve postural control in children with cerebral palsy. In addition to neurodevelopmental treatment, one group is treated with virtual reality games and the other group is treated with a hippotherapy simulator.

Interventions

Exercise Interventions

Rehabilitation methods and exercise practices to improve postural control in children with cerebral palsy. In addition to neurodevelopmental treatment, one group is treated with virtual reality games and the other group is treated with a hippotherapy simulator.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Yonca Zenginler Yazgan

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yonca Zenginler Yazgan, Asst.Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Irem N Sener, BsC

Role: CONTACT

iremn.sener@hotmail.com

+905393446762

Facility Contacts

Yonca Zenginler Yazgan, Asst.Prof.

Role: primary

y.zenginleryazgan@iuc.edu.tr

+90212 866 38 37 ext. 28321

Other Identifiers

E-74555795-050.01.04-346301

Identifier Type: -

Identifier Source: org_study_id