Reversing Physiological Dysfunction With Non-invasive Brain Stimulation: Physiological Changes From Hand Movement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Box and Block Test (BBT)- Change is being assessed
研究概览
简要总结
11 participants with upper-limb impairment will be recruited from community sources. They will be invited to participate in a 15-day trial involving the IRegained device. The study will involve 2 assessment visits to Baycrest, before and after the treatment, and 15 treatment visits. The data from the pilot study will be analyzed both quantitatively and qualitatively, as outcomes and explicit feedback from participants will be used to further optimize the device for future studies.
详细描述
This pilot study will investigate the potential changes in the brain area controlling hand movement following 15 days of exercises to improve hand function in participants with upper limb impairments resulting from stroke. A device developed by Dr. Vineet Johnson (IRegained Inc.) will be used to administer standardized exercises to improve hand function. To assess brain changes, transcranial magnetic stimulation pulses will be delivered to the motor cortex. The motor evoked potential (MEP), a muscle response evoked from the TMS, will be measured using electrodes on the hand. This study will test the feasibility of conducting motor therapy using this device while assessing potential changes in motor cortex function. Findings from this study will contribute to developing treatment trials aimed at improving impaired limb function in stroke patients and quality of life in these individuals
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a single stroke >6months prior to start of study
排除标准
- •Severe spasticity or contractures (2 or less in the CMSA)
- •any other musculoskeletal or neuromuscular disorders that compromise sensation
- •Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 24 or less).
- •Botox Injections less than 2 months prior to starting the study
结局指标
主要结局
Box and Block Test (BBT)- Change is being assessed
时间窗: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
The BBT requires participants to move cubical wooden blocks over a partition from one box to another. Grip and pinch dynamometry will be used to assess a participant's hand strength.
Action Research Arm Test (ARAT)- Change is being assessed
时间窗: Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days
ARAT is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).
ABILHAND- Change is being assessed
时间窗: Baseline- before beginning the treatment, and Post- after the completion of 15 treatment sessions, within 5 days
a subjective functional assessment tool will be used. The tool is a 23-item survey, and participants are provided with a list of various everyday functional tasks and are scored based on patient response. For example, participant will be asked whether it is 'easy', 'difficult' or 'impossible' for each of the 23 tasks.
次要结局
- Finger Goniometry- Change is being assessed(Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days)
- Grip Dynamometry- Change is being assessed(Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days)
- Pinch Dynamometry- Change is being assessed(Baseline- before beginning the treatment and Post treatment- after the conclusion of 15 treatment sessions, within 5 days)