Rehabilitation Specific Gaming in CP

NCT03403010 | Completed

• 1 other identifier: s59104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to evaluate the effectiveness of using rehabilitation-specific gaming in physical therapy of children with cerebral palsy. The primary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on the achievement of individual goals of children with bilateral spastic cerebral palsy with GMFCS level III-IV. The secondary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on trunk control and gross motor function of children with bilateral spastic cerebral palsy with GMFCS level III-IV.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scale (GAS)

  Evaluates the achievement of the individual goals per child and allows comparison of a heterogeneous group of children. GAS is essentially conducted on a 5-point measure, with the degree of attainment captured for each goal area. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (Somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (Somewhat worse) or -2 (much worse). Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it. Overall Goal Attainment Scores are then calculated by applying a formula. The composite GAS (the sum of the attainment levels x the relative weights for each goal) is transformed into a standardised measure or T score with a mean of 50 and standard deviation of 10.

  3 months

Secondary Outcomes (3)

• Trunk Control Measurement Scale (TCMS)

  3 months

• Pediatric Balance Scale (PBS)

  3 months

• Gross Motor Function Measure-88 (GMFM)

  3 months

Study Arms (3)

Control period

NO INTERVENTION

In this group conventional physiotherapy of the child will be continued and the therapist will be asked not to use any gaming activities. Also during the control period, the frequency and duration of the therapy sessions will not be influenced by the researchers.

Intervention period

ACTIVE COMPARATOR

In this group the usual individual physiotherapy program of the child will be continued as performed before the study and will be executed by the child's usual, familiar physiotherapist. The therapist will be asked to use the rehabilitation-specific gaming software every therapy session, for at least 15 to 20 minutes. The therapist will receive an extensive introduction and demonstration of the software and the researchers will participate in at least one therapy session.

Other: Rehabilitation-specific gaming platform

Wash-out period

NO INTERVENTION

The wash-out period is considered after each intervention period. As during the control period, therapy will be continued as usual during the washout-period but no gaming is allowed during therapy.

Interventions

Rehabilitation-specific gaming platform OTHER

The rehabilitation specific gaming software was developed as part of the ICT4rehab project with partners from the Vrije Universiteit Brussel and the University Libre de Bruxelles. The ICT4Rehab puts several ICT tools supporting 2/3D user interaction into place. The games can be controlled using a Kinect camera system (Microsoft(®) (Redmond, WA) Kinect™) or a Wii balance board (® NintendoTM, Japan), depending on the choice of the therapist and the needs of the child.

Intervention period

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Bilateral Spastic CP
• Gross Motor Function Classification (GMFCS) level III-IV,
• Aged between 6 and 15y
• Standardly receive physiotherapy at an intensity of minimally 2 times per week, 45 minutes per session.

You may not qualify if:

• received multilevel surgery in the previous year
• IQ \<70
• visual acuity \<3/10

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vrije Universiteit Brussel: collaborator
• Fondation Motrice: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Children are randomized into the intervention group (conventional, usual therapy including the use of rehabilitation-specific gaming) or the control group (PT, usual physiotherapy not including gaming), followed by a cross-over. After the intervention period of 3 months, wash-out period will be organized to evaluate follow-up effects.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: December 5, 2016
• Primary Completion: July 31, 2018
• Study Completion: September 30, 2018
• Last Updated: August 8, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)