Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients

Summary

Cerebral palsy (CP) is a non-progressive condition of the central nervous system caused by immature brain damage before, during or after birth. Persons affected by CP experience disability of various types. In individuals with CP, one of the most frequent symptoms is limited hand function. Other issues that often occur are muscle weakness, spasticity and problems with balance.

Injection with Botulinum Toxin A (BoNT-A) is common treatment for spasticity in patients with injury in central nervous system, e.g. traumatic brain injury, stroke, spinal cord injuries and CP.The main goal of the project is to explore if motion controlled video game treatment alone or in combination with injection treatment with BoNT-A lead to improvement of hand function, activity and participation in adults with CP.

In the project, the investigators will evaluate if these two interventions improve balance in adults with CP.

Participants will be psychologically tested in the beginning and the end of the project to evaluate if interventions can have positive effect on psychological symptoms such as depression and anxiety, The project is multidisciplinary. It involves a doctor, a nurse, an occupational therapist, a physiotherapist and a psychologist. The team will in ordinary clinical practice examine participants. Individual goals will be set up in agreement with each participant. The goals will be measurable, achievable and time bound. By reviewing scope of agreed goals, the investigators will be able to summarize most frequent problems that CP patients experience in their daily life.

There will be 25 participants in the study and they will be followed for 9 months. During every visit the team will examine participants, perform relevant tests and obtain objective and subjective outcomes. It will be assessed to what degree the goals have been achieved.

The investigators also want to evaluate long term effects of the two intervention applied in the study. Therefore, the participants will be finally assessed 3 months after last intervention period.

Based on study results, implications for future treatment volume and organization of the rehabilitation for persons with spasticity will be discussed with the participating units, hospitals, municipalities and policy makers. Professionals included in this project are also clinicians and will have an important role in ensuring that the findings are included in clinical guidelines and educational activities.

Conditions

• Cerebral Palsy, Spastic

Interventions

DRUG

IncobotulinumtoxinA

IncobotulinumtoxinA will be injected in upper extremities according to recommended guidelines. Two methods will be used in the study: auditive electromyography (EMG) and ultrasound guided injection technique. The decision process of which muscles to inject will be based on information obtained through examination of hand function, the presence of increased muscle tone during the clinical examination as well as a positive response from auditive EMG

DEVICE

Video game

The study will include the Nintendo Switch or similar consoles that include games that require the players to move their bodies while holding motion controllers in order to progress. The games included in this project has been chosen by staff at our hospitals Virtual Gaming Lab. The participants are recommended to train 30 minutes each day, 4 days a week, during the training periods. It is expected that the amount of training will vary among the participants. Thus, each participant will be instructed to keep a training-diary and weekly report number of hours played/trained through an online reporting system created with "online form", an electronic data collection system available through the University of Oslo

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• CP-foreningen

  collaborator UNKNOWN

• Sunnaas Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Per Ola Rike, Phd · Sunnaas Rehabilitation Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-17

Primary Completion

2022-03-01

Completion

2022-03-01