Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity - Motor
研究概览
简要总结
The goal of this study is to:
- Assess the usability of the SynPhNe device in a home environment.
- Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.
详细描述
The goal of this study is to explore if the SynPhNe system can be used easily at home for people who suffered a stroke. With this study, we are also investigating if the SynPhNe system used could improve your hand function in comparison to conventional therapy.
SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly via Bluetooth with the computer to provide subject with feedback while performing motor tasks with their hand. The head cap records your brain activity and gives feedback to help relaxing while exercising.
The SynPhNe system has not been approved by the U.S. Food and Drug Administration.
Study participants will be randomized by chance (like a coin toss) to one of the two groups: lab-based upper extremity research therapy or the SynPhNe system for home-based exercises.
- The lab-based upper-extremity research therapy in its content is similar to regular occupational therapy and will focus exercise movements of arm and hand.
- The group testing the SynPhNe system at home will have the system lent at no cost.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;
- •Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;
- •Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.
排除标准
- •Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;
- •Current participation in upper-extremity therapy program;
- •Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;
- •Aphasia sufficient to limit comprehension and completion of the treatment protocol;
- •No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;
- •Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
- •Previous diagnosis of dementia;
- •Previous diagnosis of neurological diseases other than Stroke;
- •History of seizures disorder and/or a seizure occuring within the last 6 months;
- •Other conditions affecting function of the stroke affected upper limb;
- •Severe pain in the stroke affected upper limb;
- •Terminal diseases with expected survival <1 year;
研究组 & 干预措施
SynPhNe therapy
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize wrist and fingers movements, including functional activities.
During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system.
Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.
干预措施: SynPhNe platform (Device)
Conventional therapy
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize wrist and fingers movements, including functional activities.
During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.
干预措施: Conventional therapy (Other)
结局指标
主要结局
Fugl-Meyer Upper Extremity - Motor
时间窗: Week 0, Week 7, Week 11
This is a motor function assessment for stroke survivors who have hemiplegia. Items are scored on a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. Higher scores are indicative of higher function. Maximum score=66.
Box and Block Test
时间窗: Week 0, Week 7, Week 11
The test is an assessment of unilateral gross manual dexterity. It is performed with each hand separately, the stroke-affected hand and the non-affected hand. The scored is calculated by counting the number of blocks that were carried over the partition from one side of the box to the other side of the box in 1 minute. Higher scores are indicative of better gross manual dexterity.
Wolf Motor Function Test - Functional Ablility
时间窗: Week 0, Week 7, Week 11
This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Functional ability scores are assigned using a 6-point ordinal scale, and the maximum score is 75. A score of 0=does not attempt with the involved arm and a score of 5=arm does participate; movement appears to be normal. Higher scores are indicative of higher function.
Wolf Motor Function Test - Performance Time
时间窗: Week 0, Week 7, Week 11
This assessment evaluates motor ability of the upper extremity during timed and functional tasks. Performance time is measured in seconds, with up to 120 seconds allowed.
次要结局
- Grip Strength(Week 0, Week 7, Week 11)
- Visual Analogue Scale for Pain(Week 0, Week 7, Week 11)
- Spasticity -- Modified Ashworth Scale(Week 0, Week 7, Week 11)
- Motor Activity Log - Amount of Use(Week 0, Week 7, Week 11)
- EQ5D Questionnaire(Week 0, Week 7, Week 11)
- Motor Activity Log - Quality of Movement(Week 0, Week 7, Week 11)
研究者
Paolo Bonato
PhD
Spaulding Rehabilitation Hospital