Robot-aided Proprioceptive Rehabilitation Training With Additional Vibro-tactile Feedback
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Joint position sense acuity of the wrist (just-noticeable-difference threshold)
研究概览
简要总结
This study investigates the effect of a robot-aided 2-day proprioceptive training of the wrist on the proprioceptive and motor function of the wrist/hand complex in patients with proprioceptive impairment. The wrist proprioceptive training consists of active movement training with augmented haptic and vibro-tactile feedback provided by a patented wrist robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of clinical and non-clinical populations. The purpose of this study is to obtain preliminary data on the effectiveness of the proprioceptive training in subjects with cortical stroke or peripheral sensory neuropathy.
详细描述
This protocol seeks to improve proprioceptive-motor function. Proprioception refers to the perception of limb position or motion and the orientation of one's body in space. Numerous medical conditions with motor symptoms are also associated with proprioceptive loss, such as osteoarthritis, Parkinson's disease, peripheral sensory neuropathy, stroke, and developmental coordination disorder.
However, therapies to improve proprioceptive function in these populations are either non-existent or very limited in scope although it is established that proprioceptive impairments severely degrade motor function. The proposed protocol focuses on proprioception for fine motor function of the hand/wrist joint complex, because hand/wrist motor control is highly important for activities of daily living.
The specific aims are to determine if a 2-day wrist proprioceptive training:
- improves limb position sense acuity,
- improves the spatial precision of wrist/hand motor tasks,
- increases the efficiency of performing such motor tasks,
- is associated with neural changes in cortical processing as measured by short-latency somatosensory evoke potentials (SEP) and motor evoked potentials (MEP) using transcranial magnetic stimulation.
The study follows a crossover design with two arms and two groups. Time frame for the completion of the study is up to 7 days depending on the start day of the week (Monday through Friday). No testing will occur on the weekend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants (both healthy and patient populations)
- •Inclusion Criteria:
- •wrist passive range of motion (ROM) more than 22.5° in flexion/extension
- •sense the vibro-tactile cues on either forearms in order to effectively receive the movement-related feedback
- •resist minimal resistance in gravity-eliminated position (score at least 2+/5 with the physical examination of manual muscle testing (Hislop, Avers, & Brown, 2013)) ) in all wrist movement directions.
排除标准
- •Regular intake of benzodiazepines.
- •Cognitive impairment: score ≥ 23 on Mini-mental state examination (Folstein, Robins & Helzer, 1983)
- •Depressive symptoms: score ≤ 19 on Beck depression inventory (Beck, Steer, & Carbin,1988).
- •Inclusion Criteria for Stroke Subjects
- •at least 3 months after stroke
- •whose age are between 30 to 75 years old.
- •Exclusion Criteria for Subjects undergoing the TMS procedure (Rossi, Hallett, Rossini, & Pascual-Leone, 2009)
- •Has implanted metal in the body.
- •Diagnosed with multiple sclerosis, major psychiatric conditions, epilepsy, history of seizures in the past 2 years, sleep deprivation, pregnancy, uncontrolled migraine, major traumatic head injury, severe heart disease, increased intracranial pressure, high consumption of alcohol, any conditions that predispose one to seizures
- •Is currently taking any pro-epileptic medication (e.g. epileptogenic drugs such as tricyclic antidepressants)
- •When no electromyography response can be elicited within the range of the TMS stimulator
- •Pregnant at the time of data collection .
研究组 & 干预措施
Proprioceptive training
This arm will receive specialized robot-aided proprioceptive training of the wrist next to usual care.
干预措施: Proprioceptive training (Behavioral)
Usual care
This arm will receive what participants have been receiving from their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy at home, day rehabilitation, or outpatient visits.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Joint position sense acuity of the wrist (just-noticeable-difference threshold)
时间窗: For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.
Using the wrist robot, the just-noticeable-difference threshold (JND) of wrist position will measured by a 2-alternative forced choice psychophysical paradigm. Participant's wrist will be passively flexed to two positions (the standard stimulus and the comparison stimuli) in random order. The standard stimulus is always 15° wrist flexion from neutral wrist position and the comparison stimulus is always larger than the standard. Participants indicate verbally which stimulus was perceived as having a larger amplitude. Unit is degrees.
次要结局
- Root-mean-square tracing error as a measure of movement accuracy(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Movement time(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Jerk cost as a measure of movement smoothness(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Fugl-Meyer Assessment score(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Nottingham Sensory Assessment score(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Peak-to-peak amplitude of motor-evoked potential (MEP)(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Canadian Occupational Performance Measure (COPM)(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)
- Mean somatosensory-evoked potential (SEP) latencies for N20 and N30(For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.)