JPRN-jRCTs032180227已完成4 期
Efficacy Assessment of Combination Therapy Including Robotic Therapy for Upper-Limb Hemiplegia after Stroke
Domen Kazuhisa0 个研究点目标入组 129 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
The change score of FMA upper limb items score as the primary outcome was not significantly different between three groups. In those,etc who completed over 80% of overall training time (PPS), when robotic therapy is used for self-training, patient's upper limb (shoulder, elbow, and forearm) functions are significantly improved compared to those who only received usual care for self-training.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •Patients must meet all of the following criteria to be enrolled in the study:
- •1) Patients who have given written, informed consent to participate in the study
- •2) Age 20 years or older, but younger than 80 years (at consent)
- •3) Patients with upper-limb hemiplegia from a clinically incipient supratentorial stroke
- •4) Six months have passed since the onset of stroke (at consent)
- •5) Undergoing outpatient or ambulatory rehabilitation
- •6) score of less than 44 points on the Fugl-Meyer Assessment (FMA) upper-limb scale
- •7) An upper-limb distal function of 1b or above on the Stroke Impairment Assessment Set (SIAS)
- •8) A score of not more than 2 on the Modified Ashworth Scale (MAS)
排除标准
- •Patients for whom any of the following is applicable are excluded from study participation.
- •1) Patients with clinically multiple strokes or a cerebellar/brain stem stroke
- •2) Patients whose upper-limb function is deemed to be recovering
- •3) Patients who have received intensive training with an upper-limb training robot
- •4) Patients who have undergone a constraint-induced (CI) therapy for upper-limb hemiplegia
- •5) Patients with other neuromuscular diseases
- •6) Patients with marked balance or gait disturbance
- •7) Patients with a serious cardiac, hepatic, or renal disease
- •8) Patients with serious aphasia or higher cortical dysfunction that can be confirmed at screening
- •9) Patients who have received a botulinum toxin injection within the last 16 weeks
- •10) Patients with extreme upper-limb pain
- •11) Patients whose cognitive function is no more than 24 points on the mini-mental state examination
- •12) Patients with a malignant tumor
- •13) Patients who lack lucid decision-making ability
- •14) Patients who are seriously terminally ill or have an uncontrolled concomitant serious disease
- •15) Other patients deemed not eligible for the study by the investigator
研究者
相似试验
已完成
不适用
The efficacy of upper extremity robotic therapy combined with constraint-induced movement therapy in chronic post-stroke hemiplegia.JPRN-UMIN000022509Hyogo College of Medicine129
招募中
3 期
Investigating the effect of platelet-rich plasma in androgenetic alopeciaAndrogenetic alopecia.Androgenic alopeciaIRCT20221230056991N1Esfahan University of Medical Sciences60
尚未招募
3 期
Comparison of the effectiveness of combined treatment of topical L-carnitine lotion 1% with clotrimazole lotion 2% and clotrimazole lotion 2% alone in the treatment of seborrheic dermatitis of the head (scalp)IRCT20150706023081N4Esfahan University of Medical Sciences64
已完成
不适用
Comparison of the therapeutic benefit to combination therapy of botulinum neurotoxin and cast as well as single dose of botulinum neurotoxin on the wrist spasticity in different time intervalsG81.1I63.9Spastic hemiplegiaCerebral infarction, unspecifiedDRKS00010413eurologisches Rehabilitationszentrum Leipzig60
已完成
2 期
Phase 2a Clinical Study to evaluate efficacy and safety of JTE-451 ointment in patients with plaque psoriasis.Plaque PsoriasisJPRN-jRCT2031210232Miwa Yasushi67