Technology Assisted Rehabilitation in CP
The Effect of Technology Assisted Rehabilitation Interventions on Postural Control, Activity and Participation in Children With Cerebral Palsy
1 other identifier
observational
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 7, 2022
June 1, 2022
3 months
May 25, 2022
June 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Trunk Control Measurement Scale (TCMS)
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. The TCMS evaluates of static and dynamic sitting balance. TCMS consists of 15 questions in total. A higher score on this scale represents better performance, with a TCMS total score ranging from 0 to 58. We will use this scale at the beginning and end of our study (after 8 weeks) so that we can see the effectiveness of the treatment methods we will apply.
Baseline and after 8 weeks
Selective Control Assessment of the Lower Extremity (SCALE)
The Selective Control Assessment of the Lower Extremity (SCALE) is a clinical tool developed to quantify selective voluntary motor control (SVMC) in patients with cerebral palsy (CP). Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally. We will use this scale at the beginning and end of our study (after 8 weeks) so that we can see the effectiveness of the treatment methods we will apply.
Baseline and after 8 weeks
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most universally accepted clinical tool used to measure the increase of muscle tone. Hip flexors, hip adductors, knee flexors and ankle plantar flexor muscles in the lower extremities of the cases are evaluated bilaterally. We will use this scale at the beginning and end of our study (after 8 weeks) so that we can see the effectiveness of the treatment methods we will apply.
Baseline and after 8 weeks
BeCure Balance Assessment System
The developed system evaluates the person's static standing balance, body center of gravity, load distributions in each foot, postural sway and proprioception. Evaluations made on the Nintendo Wii balance platform can be made as one foot-two feet, eyes open-closed, with or without images. We will use this scale at the beginning and end of our study (after 8 weeks) so that we can see the effectiveness of the treatment methods we will apply.
Baseline and after 8 weeks
Secondary Outcomes (2)
Pediatric Evaluation of Disability Inventory (PEDI)
Baseline and after 8 weeks
Pediatric Quality of Life Inventory™ (PedsQL) 3.0 CP Module
Baseline and after 8 weeks
Study Arms (2)
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.
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.
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.
Eligibility Criteria
Children between the ages of 5 and 18 who have been diagnosed with spastic cerebral palsy constitute the population of the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa
Istanbul, 34500, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yonca Zenginler Yazgan, Asst.Prof.
Istanbul University - Cerrahpasa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof.
Study Record Dates
First Submitted
May 25, 2022
First Posted
June 7, 2022
Study Start
March 1, 2022
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share