NCT04290169: CPSpast

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

Status unknown NA Last updated 28 February 2020

What this trial tests

NA trial testing IncobotulinumtoxinA in Cerebral Palsy, Spastic in 25 participants. Status unknown.

Timeline

17 February 2020

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	Sunnaas Rehabilitation Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	17 February 2020
Primary completion	1 March 2022
Estimated completion	1 March 2022

Drugs / interventions tested

• IncobotulinumtoxinA (INCOBOTULINUMTOXINA) — full drug profile →
• Video game

Conditions studied

• Cerebral Palsy, Spastic — all drugs for Cerebral Palsy, Spastic →

Sponsor

Sunnaas Rehabilitation Hospital

Who can join

Adults 18 to 80, any sex, with Cerebral Palsy, Spastic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.