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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 主要终点
- Goal Attainment Scale score after video games therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Adults with hemiplegic spastic cerebral palsy
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.
干预措施: IncobotulinumtoxinA (Drug)
Adults with hemiplegic spastic cerebral palsy
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.
干预措施: Video game (Device)
结局指标
主要结局
Goal Attainment Scale score after video games therapy
时间窗: 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
时间窗: 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
时间窗: 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 baseline
时间窗: 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
时间窗: 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)
次要结局
- 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)
- House Functional Classification System(Baseline)
- Change from baseline Modified Ashworth Scales 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)
- Change from baseline Range of Motion 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)
- Change from baseline Numeric rating scale (0-10) of symptoms related to pain at 9 months(Baseline, 9 months after baseline)
- WAIS-IV Coding (Wechsler Adult Intelligence Scale )(Baseline)
- Change from baseline Hopkins Symptoms Checklist 25 score at 9 months(Baseline, 9 months after baseline)
- Change from baseline Action Research Arm Test (ARAT) 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)
- Change from baseline Mini-Balance Evaluation Systems Test 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)
- Change from baseline Fatigue Severity Scale (FSS) at 9 months(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(Baseline, 9 months after baseline)