Cerebral Palsy, SpasticCPSpastNCT04290169
Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients
A study testing IncobotulinumtoxinA and Video game in people with Cerebral Palsy, Spastic, run by Sunnaas Rehabilitation Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- IncobotulinumtoxinA and Video game
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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
- Being tested
- IncobotulinumtoxinA, Video game
- Keywords
- Cerebral palsy, Cognition, Spasticity, BoNT-A, Botulinum Toxin A, video game, balance, Upper extremity function
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
Also called Botulinum Toxin A, Xeomin, BoNT-A
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
Video gameDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IncobotulinumtoxinA; Device: Video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 9 months after baseline
Secondary outcomes (15)
Change from baseline Patient Specific Functional Scale score at project defined points of assesment
Patient Specific Functional Scale helps participants to define and assess individual goals, motivation and pain related to activities. Scale range 0-10, higher score means a better outcome.
Measured: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Gross Motor Function Classification System
The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities. Classification levels 1-5, lower score means a better outcome
Measured: Baseline
Manual Ability Classification System (MACS)
The Manual Ability Classification System (MACS) describes how patients with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the patient's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. Classification levels 1-5, lower score means a better outcome.
Measured: Baseline
Change from baseline Hand Grip Dynamometer score at project defined points of assesment
Simultaneous bilateral dynamic grip strength testing With Hand Grip Dynamometer. Score in percentage. The higher the better.
Measured: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Zancolli Classification Hand Function
This scale explains the grasping and release patterns between the wrist and fingers and hand appearance of the spastic patients. It explains the hand appearance in degrees and that, degrees of extension can be measured using goniometer. The responses of the scale is scored as 1, 1a, 2a, 2b and 3. The best score is 1
Measured: Baseline
House Functional Classification System
Classifies thumb position from 0 to 5. The higher the better.
Measured: Baseline
Change from baseline Modified Ashworth Scales score at project defined points of assesment
The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scale range from 0 to 4, 0 is most favourable outcome.
Measured: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Range of Motion score at project defined points of assesment
Measuring active and passive range of arm joints motion using goniometer
Measured: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months
Self-perceived pain related to spasticity. Score 0 means no pain.
Measured: Baseline, 9 months after baseline
WAIS-IV Coding (Wechsler Adult Intelligence Scale )
Coding measures visual processing speed, short-term visual memory, and the ability to shift the eyes efficiently back and forth between the "key" and the responses. This task requires fine motor skills but does not require expressive Language. The higher score is better.
Measured: Baseline
Change from baseline Hopkins Symptoms Checklist 25 score at 9 months
The HSCL-25 is a symptom inventory which measures symptoms of anxiety and depression. It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms.
Measured: Baseline, 9 months after baseline
Change from baseline Action Research Arm Test (ARAT) score at project defined points of assesment
Assessment for a person's ability to handle objects differing in size, weight and shape. Score range is from 0 to 3, 3 being the best score.
Measured: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Mini-Balance Evaluation Systems Test score at project defined points of assesment
Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Score range 0 to 28. The higher score the better.
Measured: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Fatigue Severity Scale (FSS) at 9 months
The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. FSS consists of answering a short questionaire that requires the subject to rate his or her own level of fatigue.
Measured: Baseline, 9 months after baseline
Change from baseline EQ-5D-5L (EuroQol 5 Dimensions 5 Level) Health related quality of life score at 9 months
Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses.
Measured: Baseline, 9 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start17 Feb 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Göteborg University, CP-foreningen
- Responsible party
- Sponsor
- Investigators
- Per Ola Rike, Phd, Study director, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290169
- Sponsor's protocol ID
- CPSpast
- Acronym
- CPSpast
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04290169
- Acronym / sponsor ID
- CPSpast / CPSpast
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy, Cognition, Spasticity, BoNT-A, Botulinum Toxin A, video game, balance, Upper extremity function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Göteborg University, CP-foreningen
- Study start
- 17 Feb 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adults with hemiplegic spastic cerebral palsy | Other | Drug: IncobotulinumtoxinA, Device: Video gameAdults (> 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinAAlso: Botulinum Toxin A, Xeomin, BoNT-AIncobotulinumtoxinA 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 | Drug | Adults with hemiplegic spastic cerebral palsy |
| Video gameThe 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 | Device | Adults with hemiplegic spastic cerebral palsy |
Primary outcome
Goal Attainment Scale score at baseline
Time frame: 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)
Goal Attainment Scale score after video games therapy
Time frame: 3 months after 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)
Goal Attainment Scale score 6 weeks after injection therapy with BoNT-A
Time frame: 4.5 months after 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)
Goal Attainment Scale score 3 months after injection therapy with BoNT-A
Time frame: 6 months after 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)
Goal Attainment Scale score at the end of follow up period
Time frame: 9 months after 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)
15 secondary outcomes
Change from baseline Patient Specific Functional Scale score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Gross Motor Function Classification System
Time frame: Baseline
Manual Ability Classification System (MACS)
Time frame: Baseline
Change from baseline Hand Grip Dynamometer score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Zancolli Classification Hand Function
Time frame: Baseline
House Functional Classification System
Time frame: Baseline
Change from baseline Modified Ashworth Scales score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Range of Motion score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months
Time frame: Baseline, 9 months after baseline
WAIS-IV Coding (Wechsler Adult Intelligence Scale )
Time frame: Baseline
Change from baseline Hopkins Symptoms Checklist 25 score at 9 months
Time frame: Baseline, 9 months after baseline
Change from baseline Action Research Arm Test (ARAT) score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Mini-Balance Evaluation Systems Test score at project defined points of assesment
Time frame: Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline
Change from baseline Fatigue Severity Scale (FSS) at 9 months
Time frame: Baseline, 9 months after baseline
Change from baseline EQ-5D-5L (EuroQol 5 Dimensions 5 Level) Health related quality of life score at 9 months
Time frame: Baseline, 9 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ola Rike, Phd study director
Sunnaas Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
A study testing IncobotulinumtoxinA and Video game in people with Cerebral Palsy, Spastic, run by Sunnaas Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jelena Simic, MD (0047 92839209, jelena.simic@sunnaas.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale score at baseline (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.