Efficacy Assessment of Combination Therapy Including Robotic Therapy for Upper-Limb Hemiplegia after Stroke
- Conditions
- Chronic post-stroke upper-limb hemiplegic patients
- Registration Number
- JPRN-jRCTs032180227
- Lead Sponsor
- Domen Kazuhisa
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 129
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the FMA upper-limb scor
- Secondary Outcome Measures
Name Time Method 1) Changes in AOU and QOM of the MAL-14<br>2) Changes in components of the FMA upper-limb scale<br>3) Change in the ARAT score<br>4) Change in the MI<br>5) Change in the MAS score<br>6) Changes in the AROMs of the shoulder, elbow, forearm, wrist, and fingers<br>7) Change in the SIS score