Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Upper extremity functional ability measured with Modified Rankin Scale
研究概览
简要总结
The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.
详细描述
This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to follow study instructions
- •Ability to likely complete all required visits
- •Ability to comply with the therapy protocol as assessed by the investigator
- •Must be English speaking
- •Subjects must have had a unilateral stroke
排除标准
- •Severe upper extremity spasticity suggested by an Ashworth score of ≥3 at any joint, or restriction of full passive range of motion.
- •Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
- •Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- •History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- •Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- •Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- •Patients who are cognitively impaired.
- •Patients who lack capacity to consent.
结局指标
主要结局
Upper extremity functional ability measured with Modified Rankin Scale
时间窗: 12 Weeks
Range of motion will be measured using video
时间窗: 12 Weeks
Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.
Performance tasks of the Fugl-Meyer Scale (FMS)
时间窗: 12 Weeks
This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Stroke-related quality of life measured with the Stroke Impact Scale
时间窗: 12 Weeks
Spasticity measured using the Modified Ashworth Scale
时间窗: 12 Weeks
Upper extremity functional ability measured using the Wolf Motor Function Test
时间窗: 12 Weeks
次要结局
未报告次要终点