Evaluating the Use of Transcranial Direct Current Stimulation as an Adjunct to Physiotherapy in Children and Youth With Acquired Brain Injury: Does Physiotherapy Plus Brain Stimulation Equal Better Motor Recovery?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Eligibility Rate
研究概览
简要总结
The current study will evaluate the feasibility of transcranial direct current stimulation (tDCS) combined with an existing intensive physiotherapy program for children with ABI within the in/day-patient brain injury program at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. This feasibility randomized control trial will allocate 30 participants with ABI (age 5 to 18 years) to one of two treatment groups. One group will receive active tDCS prior to four of their existing physiotherapy sessions each week for a total of 16 sessions while the other group will receive sham/placebo tDCS prior to their physiotherapy sessions. Recovery of gross motor function will be compared between groups after the four weeks of tDCS treatment and again after three months to evaluate the short and longer-term impact of tDCS on an existing intensive physiotherapy program. Feasibility will be evaluated by tracking process, resource, and treatment indicators such as eligibility, enrollment, adherence, and tolerance rates.
详细描述
Objectives
The purpose of this study is to test the feasibility of using tDCS as a pre-treatment adjunct to intensive physiotherapy (the 'physio+tDCS' protocol) for children with ABI in the inpatient brain injury program at Holland Bloorview. The primary objectives of our study are to answer the following questions:
- Is it feasible to implement a 'physio+tDCS' protocol within an existing inpatient ABI rehabilitation program based on participant eligibility, recruitment, tolerance, retention, and adherence to treatment protocol (e.g. session frequency and completion timelines)?
- What is the effect of using tDCS as an adjunct to intensive physiotherapy on the recovery of gross motor function in children with moderate to severe ABI, as measured by individualized goal achievement and standardized gross motor outcome measures? METHODS Trial design Using a feasibility randomized control trial (RCT) study design, 30 children with moderate to severe ABI, enrolled in intensive brain injury rehabilitation at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, will be randomized to the active or sham (control) tDCS intervention, which will be paired with individualized intensive physiotherapy (i.e., 'physio+tDCS' and 'physio+sham').
Randomization and Blinding Once enrolled in the study, an independent research assistant (RA) will randomly assign each child to the "sham" or "active" tDCS treatment group using a computer randomization web-based program and approach described below. Only the RAs involved in the study will be aware of each participant's treatment group assignment. The participants and the assessing/treating PTs will be blinded to the participant's treatment group.
Intervention tDCS Treatment- Depending on treatment group allocation, participants will receive 20 minutes of active tDCS or sham tDCS (provided by a trained RA) immediately prior to four of their physiotherapy sessions each week over 4 weeks for a total of 16 sessions. Children and PTs will be blinded to their tDCS/sham allocation. Two electrodes (5x7cm) in size will be used such that the anodal electrode will be attached to the Cz position on the scalp, to target the lower extremity region of bilateral primary motor cortices, and the cathodal electrode will be attached to the central supraorbital (Fpz) area of the forehead (20). Each tDCS treatment will consist of up to 2.0 mA of stimulation, adjusting for the child's age, head size, and tolerance as required. Participants will be told which treatment group they were allocated to after completing their final assessment (3 months after completing the treatment protocol). Participant symptoms and safety will be tracked before, during, and after each tDCS session. Adverse events reported via a REB-approved standard process to an independent in-house safety monitoring committee (SMC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Physiotherapists providing treatment, physiotherapists conducting assessment, research coordinator, principal investigators, participants are all blinded to treatment allocation. Research assistants administered the transcranial direct current stimulation are not blinded.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sustained a cerebral stroke (ischaemic or haemorrhage) or TBI within the last three months;
- •admitted to Holland Bloorview for intensive brain injury rehabilitation in the in/day patient programs;
- •medically stable, as determined by their primary physician at Holland Bloorview;
- •receiving active motor learning-based physiotherapy intervention four to five times per week, as prescribed by their treating PT;
- •tolerate approximately 45 minutes of physiotherapy intervention;
- •able to sit at the edge of the bed independently for 5s
- •capable of participating in standardized physiotherapy assessment, from a cognitive and behavioural perspective, and;
- •able to communicate discomfort (verbally or non-verbally).
排除标准
- •primary injury of the cerebellum
- •pre-existing seizure disorder (i.e., prior to ABI);
- •anti-seizure medication not optimized at the time of study enrollment (i.e., physician is actively adjusting type or dose of anti-seizure medication)
- •brain tumour;
- •metal implants in the head;
- •cranial bone flap removed;
- •stitches/staples or open wound on the head;
- •experience with tDCS in the last two years (as knowledge of the sensation of active tDCS will affect blinding of treatment groups);
- •diagnosed with another neurological disorder(s) affecting gross motor function (e.g., cerebral palsy, spinal cord injury, guillain-barre syndrome, etc...);
- •requires more than 15 minutes per physiotherapy treatment session of non-motor learning content (e.g., behavioural redirection, craniosacral therapy, vestibular therapy, passive range of motion)
- •lower extremity weight bearing activity restrictions secondary to injuries (e.g., fracture, ligamentous injury)(at the time of study enrollment)
- •non-orthopaedic physical activity restrictions secondary to other injuries (e.g., splenic laceration)
- •balances on most affected leg for greater than 5s
- •enrolment in another treatment-based research study
结局指标
主要结局
Eligibility Rate
时间窗: Through study completion, an average of two years
The proportion of eligible participants compared to the number of children admitted for inpatient brain injury rehabilitation. Reported as a percentage.
Enrollment Rate
时间窗: Through study completion, an average of two years
The proportion of eligible participants who enrollment in the study. Reported as a percentage
Adherence Rate
时间窗: Through study completion, an average of two years
The proportion of enrolled participants who complete at least 12 of the 16 transcranial direct current stimulation (followed by physiotherapy) sessions.
Transcranial Direct Current Stimulation Tolerance
时间窗: Through study completion, an average of two years
The mean dose (measured in milliamperes) of transcranial direct current stimulation each participant receives.
Transcranial Direct Current Stimulation Tolerability Questionnaire
时间窗: 1st reassessment (after 4-week treatment protocol)
At baseline the participant indicate the most enjoyable and least enjoyable activity they have experienced in the last month. They order these two activities in relation to 7 familiar childhood experiences (e.g., watching TV, going to the dentist, going for a long car ride). At followup, the child is presented with the baseline ordering of these 9 activities and asked to indicate where transcranial direct current stimulation fits in the order (e.g. more enjoyable than going to the dentist but less enjoyable than watching TV).
Canadian Occupational Performance Measure
时间窗: Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)
The Canadian Occupational Performance Measure is a standardized outcome measure that allows children and families to set goals and evaluate their performance and satisfaction with each goal on a scale of 1 to 10, where higher ratings mean increased performance and satisfaction. In this study, the goals will be participation-based goals related to gross motor activities.
Gross Motor Function Measure
时间窗: Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months)
A standardized physiotherapy assessment (validated for children with ABI) that assesses gross motor function in five dimensions (A- lying \& rolling, B- sitting, C- crawling \& kneeling, D- standing, walking, E-running \& jumping). Each of the 88 items is scored from 0-3.
次要结局
- Goal Attainment Scaling(Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months))
- Acquired Brain Injury Challenge Assessment(Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months))
- Pediatric Evaluation of Disability Inventory (Mobility and Self-Care domains)(Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months))
- 10 metre fastest walk test(Change from baseline to 1st reassessment (4 weeks) to 2nd reassessment (3 months))