Clinical trial NCT06073743: Video Based Games Exercise Training in Individuals With Cerebral Palsy
Official title: The Effect of Video Based Games Exercise Training on Selective Motor Control, Fear of Falling and Functional Capacity in Individuals With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Spastic cerebral palsy
Virtual reality
Selective motor control
Fear of falling
Functional capacity
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a non-progressive neurological disorder characterized by a persistent decline in sensory, cognitive or especially gross and fine motor functions during infancy or early childhood. In children with spastic CP, spasticity, muscle weakness, delay in motor development, inadequacy of gross and fine motor skills, selective motor control and functional capacity may be affected. Selective motor control (SMC) is the ability to isolate a muscle or muscle group to perform a specific movement. In children with CP, spasticity directly causes impairment of SMC, as movement patterns governed by flexor or extensor synergies are affected, which inhibits functional movements. Motor dysfunction in CP causes activity limitations and can negatively affect functional capacity. In addition, falls may increase in individuals with CP due to poor balance control, resulting in pain, injury and disability, and may cause individuals to lose confidence in their ability to perform routine activities. Increased fear of falling in individuals with CP may also lead to restriction of activities.It was discussed that the interactive computer game has possible evidence of efficacy allowing to improve gross motor function in individuals with CP. It also appears to have the potential to produce gross motor improvements in terms of strength, balance, coordination and gait for individuals with CP.As a result of our literature review, studies investigating the effect of virtual reality games on gait, balance and coordination in children with CP were observed. However, the effect of virtual reality games on selective motor control has not been sufficiently investigated. The aim of our study, which is planned to eliminate this deficiency in the literature, is to investigate the effect of video game-based exercise training, which provides higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity in individuals with CP.

Detailed description: The effect of Virtual Reality Kinect video games, which provide higher motivation than conventional physical therapy methods, on selective motor control, fear of falling and functional capacity will be examined.

The study will include children with spastic CP between the ages of 6-18 years who are attending a Special Education and Rehabilitation Center and who agree to participate in the study. According to the power analysis based on the reference article, it is planned to include 26 people in the study, 13 in the convention physiotherapy group and 13 in the video game-based exercise group.

The families of the children included in the study will be asked to sign an Informed Consent Form and the children will be asked to sign a Child Consent Form for Research Purposes. Demographic data such as gender, age, type of extremity involvement, age at diagnosis will be recorded before the training. The cognitive level of the individuals will be evaluated with the Mini Mental State test, gross motor levels will be classified according to the Gross Motor Function Classification System and hand skills will be classified according to the Hand Skills Classification System. Selective motor control of the upper extremity will be evaluated with the Selective Control of Upper Extremity Evaluation Scale (SCUES) and selective motor control of the lower extremity will be evaluated with the Selective Control of Lower Extremity Evaluation Scale (SCALE). Individuals' balance skills in daily living activities will be evaluated with the Pediatric Balance Scale, fear of falling will be evaluated with the Pediatric Fear of Falling Scale, and functional capacity will be evaluated with the 6-minute walk test.

Eligibility criteria: Inclusion Criteria

* Being diagnosed with spastic CP
* Being between the ages of 6-18
* Being at level I, II, III according to MACS
* Being at level I, II, III according to GMFCS
* Scoring 24 points and above on the Mini Mental State Examination
* To have adequate communication skills
* The family agrees to the inclusion of their child in the study
* Child's willingness to participate in the study
* Regular attendance to exercise training within the specified time periods

Exclusion Criteria:

* Any botulinum toxin application and surgical intervention to the lower and upper extremities in the last 6 months
* Serious vision and hearing problems
* Children who have difficulty understanding and following the rules of the game,
* Receiving surgery or botox application to the lower or upper extremity
* Individuals with joint contracture
* Those with pacemakers because they emit radio waves

Primary outcomes:
measure: Selective Voluntary Motor Control of the Upper Extremities (SCUES)
timeFrame: 10 weeks
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 10 weeks
measure: Six Minute Walk Test (6MWT)
timeFrame: 10 weeks
measure: Pediatric Fear of Falling Questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Pediatric Balance Scale (PBS)
timeFrame: 10 weeks
measure: Gross Motor Classification System (GMFCS)
timeFrame: Baseline
measure: Manual Ability Classification System (MACS)
timeFrame: Baseline
measure: Modified Mini Mental Test (MMMT)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Bolu Abant Izzet Baysal University, Faculty of Health Sciences
name: Sezen Tezcan
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant Izzet Baysal University
name: Süveybe Yavaş
role: PRINCIPAL_INVESTIGATOR
References: