Video Based Games Exercise Training in Individuals With Cerebral Palsy

NCT06073743 | Completed

• 1 other identifier: AIBU-FTR-ST-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy

Keywords

Spastic cerebral palsy; Virtual reality; Selective motor control; Fear of falling; Functional capacity

Outcome Measures

Primary Outcomes (4)

• Selective Voluntary Motor Control of the Upper Extremities (SCUES)

  SCUES is a test that evaluates selective motor control of the upper extremity with a score between 0-3. SCUES assesses the shoulder, elbow, forearm, wrist and fingers bilaterally. Motion at each of the five joint levels is graded on a four-point scale: Normal Selective Motor Control (3 points) M3, Mildly Diminished Selective Motor Control (2 points) M2, Moderately, Diminished Selective Motor Control (1 point) M1, No Selective Motor Control (0 points) M0. Higher scores mean a better outcomes.

  10 weeks

• Selective Control Assessment of the Lower Extremity (SCALE)

  It is a test that evaluates the selective motor control of the lower extremity with a score between 0 and 2. It evaluates the hip, knee, ankle and toe joints bilaterally.Scoring is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).Higher scores mean a better outcomes.

  10 weeks

• Six Minute Walk Test (6MWT)

  The 6MWT is a simple, submaximal, clinical exercise test that measures the distance walked in 6 minutes under controlled conditions. The 6MWT has been used in children with cerebral palsy (CP) in recent years. In these populations, the 6MWT is considered a measure of overall 'functional status' as 6MWT performance involves the integrated response of multiple body systems.

  10 weeks

• Pediatric Fear of Falling Questionnaire

  It is a scale that assesses the fear of falling in activities of daily living in the pediatric population. There are 6 main topics. There are a total of 34 items in which children's fear of falling is questioned during different activities. Participants receive a score between 0 and 68, with higher scores indicating higher fear of falling.

  10 weeks

Secondary Outcomes (4)

• Pediatric Balance Scale (PBS)

  10 weeks

• Gross Motor Classification System (GMFCS)

  Baseline

• Manual Ability Classification System (MACS)

  Baseline

• Modified Mini Mental Test (MMMT)

  Baseline

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of weight transfer exercises to the upper and lower extremities, exercises to improve elective motor control (including isolated joint movements). exercises), balance and coordination exercises (weight transfer to the right-left, front-back on the balance board, cross-arm-leg exercises, exercises for balance and protective reactions), walking training will be applied.

Other: Conventional Physiotherapy

Video Game Based Exercise Training Group

EXPERIMENTAL

30 minutes of upper and lower extremity strengthening exercises, upper and lower extremity stretching exercises, functional exercises to increase joint range of motion, tone regulation exercises, 30 minutes of XBox Video Games (10 minutes of Reflex Ridge, 10 minutes of Rallyball, 10 minutes of River rush games) will be applied.

Other: Conventional Physiotherapy; Other: Video Game Based Exercise Training

Interventions

Conventional Physiotherapy OTHER

The conventional physiotherapy program will be applied 2 days a week, 60 minutes a day for 10 weeks and consist of weight bearing on the upper and lower extremities, strengthening, functional stretching exercises, walking training and balance exercises.

Conventional Physiotherapy Group; Video Game Based Exercise Training Group

Video Game Based Exercise Training OTHER

In the Video Game Based Exercise Training program, in addition to the same conventional physiotherapy application for 30 minutes a day, 2 days a week for 10 weeks, 30 minutes of Microsoft Xbox Kinect video games such as reflex ridge and rallyball are used.

Video Game Based Exercise Training Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Child's willingness to participate in the study
• Regular attendance to exercise training within the specified time periods

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sezen Tezcan

  Bolu Abant Izzet Baysal University, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Süveybe Yavaş

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: December 25, 2023
• Primary Completion: January 7, 2025
• Study Completion: February 15, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)