Cerebral Palsy, Spastic Clinical Trial
— CPSpastOfficial 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.
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.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunnaas Rehabilitation Hospital | CP-foreningen, Göteborg University, Rigshospitalet, Denmark |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | 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 | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | 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 | Baseline | |
Secondary | House Functional Classification System | Classifies thumb position from 0 to 5. The higher the better. | Baseline | |
Secondary | 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. | Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | Change from baseline Range of Motion score at project defined points of assesment | Measuring active and passive range of arm joints motion using goniometer | Baseline, 3 months after baseline, 4,5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | 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. | Baseline, 9 months after baseline | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline, 9 months after baseline | |
Secondary | 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. | Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | 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. | Baseline, 3 months after baseline, 4.5 months after baseline, 6 months after baseline, 9 months after baseline | |
Secondary | 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. | Baseline, 9 months after baseline | |
Secondary | 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. | Baseline, 9 months after baseline |
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