Clinical trial NCT04290169: Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients
Official title: Utilizing Motion Controlled Video Games and Botulinum Toxin A Treatment to Improve Motor Function, Activity and Participation in Persons With Spastic Cerebral Palsy - a Single-subject Design Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral palsy
Cognition
Spasticity
BoNT-A
Botulinum Toxin A
video game
balance
Upper extremity function
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Göteborg University
name: CP-foreningen
First posted: 2020-02-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The single subject design was chosen due to its sensitivity to individual differences which is a relevant feature when studying heterogenous population as adults with spastic CP. The study is a multiple-treatment design with two intervention phases, an ABACAA design. The study include a baseline assessment phase (A1), a three-month intervention phase with motion controlled video game training (B), post-intervention assessment (A2), a second three-month intervention phase with Motion Controlled Video Game (MCVG) treatment and BoNT-A treatment (C) including an assessment in the middle when BoNT-A usually have its peak (6 weeks after application) (A3), post-intervention assessment three months after application of BoNT-A (A4) and a follow-up assessment 9 months after beginning of first intervention (A5). All participants will be medically examined and assessed with functional measures in all assessment phases. The timeframe from baseline to follow-up is approximately 9 months.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Goal Attainment Scale score at baseline
timeFrame: Baseline
measure: Goal Attainment Scale score after video games therapy
timeFrame: 3 months after baseline
measure: Goal Attainment Scale score 6 weeks after injection therapy with BoNT-A
timeFrame: 4.5 months after baseline
measure: Goal Attainment Scale score 3 months after injection therapy with BoNT-A
timeFrame: 6 months after baseline
measure: Goal Attainment Scale score at the end of follow up period
timeFrame: 9 months after baseline
Secondary outcomes:
measure: Change from baseline Patient Specific Functional Scale score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Gross Motor Function Classification System
timeFrame: Baseline
measure: Manual Ability Classification System (MACS)
timeFrame: Baseline
measure: Change from baseline Hand Grip Dynamometer score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Zancolli Classification Hand Function
timeFrame: Baseline
measure: House Functional Classification System
timeFrame: Baseline
measure: Change from baseline Modified Ashworth Scales score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Change from baseline Range of Motion score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months
timeFrame: Baseline, 9 months after baseline
measure: WAIS-IV Coding (Wechsler Adult Intelligence Scale )
timeFrame: Baseline
measure: Change from baseline Hopkins Symptoms Checklist 25 score at 9 months
timeFrame: Baseline, 9 months after baseline
measure: Change from baseline Action Research Arm Test (ARAT) score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Change from baseline Mini-Balance Evaluation Systems Test score at project defined points of assesment
timeFrame: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
measure: Change from baseline Fatigue Severity Scale (FSS) at 9 months
timeFrame: Baseline, 9 months after baseline
measure: Change from baseline EQ-5D-5L (EuroQol 5 Dimensions 5 Level) Health related quality of life score at 9 months
timeFrame: Baseline, 9 months after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Sunnaas Rehabilitation Hospital
name: Per Ola Rike, Phd
role: STUDY_DIRECTOR
References: