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

Sunnaas Rehabilitation Hospital

Status: Unknown

Conditions: Cerebral Palsy, Spastic

Treatments: Device: Video game; Drug: IncobotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT04290169

CPSpast

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with CP (>= 18 years)
• Spastic CP with one upper extremity affected
• Grasp function and ability to open and close the hand actively
• "Spastic hand and arm" as a prevalent finding verified by clinical examination
• Ability to walk

Exclusion criteria

• Musculoskeletal illnesses that affect limbs (e.g., arthrosis, rheumatoid arthritis and amputations).
• BoNT-A treatment of upper limbs in the previous 6 months.
• Orthopedic or neurosurgery procedures performed on the upper limbs in the last 12 months.
• Wrist contracture that prevents patient to play video games
• Severe cognitive deficits
• Other neurological disorders and severe psychiatric illnesses
• Active user of MCVG console at home

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Adults with hemiplegic spastic cerebral palsy

Other group

Description:

Adults (\> 18 years old) with hemiplegic spastic cerebral palsy, with reduced hand function and spasticity as prevalent finding under clinical examination. Also these patients can walk but have problems with balance. Participants' cognitive function does not limit them to perform video game training.

Treatment:

Drug: IncobotulinumtoxinA

Device: Video game