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

NCT04290169 | Unknown

• 1 other identifier: CPSpast
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Cerebral palsy; Cognition; Spasticity; BoNT-A; Botulinum Toxin A; video game; balance; Upper extremity function

Outcome Measures

Primary Outcomes (5)

• Goal Attainment Scale score at baseline

  Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)

  Baseline

• Goal Attainment Scale score after video games therapy

  Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)

  3 months after baseline

• Goal Attainment Scale score 6 weeks after injection therapy with BoNT-A

  Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)

  4.5 months after baseline

• Goal Attainment Scale score 3 months after injection therapy with BoNT-A

  Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)

  6 months after baseline

• Goal Attainment Scale score at the end of follow up period

  Goal Attainment Scale (GAS), where the participant defines specific problem, e.g., activity limitations and participation restrictions caused by upper limb function difficulties, and evaluates to what extent the goal is achieved after treatment and/or training. GAS have previously been utilized to quantify the treatment effects of BoNT-A. Each participant in collaboration with clinicians formulates specific short-term and long-term goals that correspond to the International Classification of Functioning, Disability and Health (ICF) Activity and Participation levels. Minimum scale value -2 (least favorable outcome), Maximum scale value +2 (most favorable outcome)

  9 months after baseline

Secondary Outcomes (15)

• Change from baseline Patient Specific Functional Scale score at project defined points of assesment

  Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline

• Gross Motor Function Classification System

  Baseline

• Manual Ability Classification System (MACS)

  Baseline

• Change from baseline Hand Grip Dynamometer score at project defined points of assesment

  Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline

• Zancolli Classification Hand Function

  Baseline

Study Arms (1)

Adults with hemiplegic spastic cerebral palsy

OTHER

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.

Drug: IncobotulinumtoxinA; Device: Video game

Interventions

IncobotulinumtoxinA DRUG

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

Also known as: Botulinum Toxin A, Xeomin, BoNT-A

Adults with hemiplegic spastic cerebral palsy

Video game DEVICE

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

Adults with hemiplegic spastic cerebral palsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Göteborg University: collaborator
• CP-foreningen: collaborator

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Per Ola Rike, Phd

  Sunnaas Rehabilitation Hospital

  STUDY DIRECTOR

Central Study Contacts

Jelena Simic, MD

CONTACT

0047 92839209; jelena.simic@sunnaas.no

Grethe Maanum, Phd

CONTACT

0047 91776982; grethe.manum@sunnaas.no

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 28, 2020
• Study Start: February 17, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share