Efficacy Assessment of Combination Therapy Including Robotic Therapy for Upper-Limb Hemiplegia after Stroke

JRCT ID: jRCTs032180227

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic post-stroke upper-limb hemiplegic patients
• Date of first enrollment: 29/11/2016
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Randomly allocate eligible patients to one of the following three groups to receive training 3 times weekly for 10 weeks.
1)Self-training with robotic therapy: 40 minutes (2 units)/day
Usual care (stretch, joint range-of-motion exercise, correct-movement exercise, ADL exercise): 20 minutes (1 unit)/day
2)Self-training with robotic therapy: 40 minutes (2 units)/day
Strategies for linking functional improvements achieved in task-oriented training and individual exercises for upper limbs to daily life: 20 minutes (1 unit)/day
3)Self-training that follows the concept of usual care: 40 minutes (2 units)/day
Usual care: 20 minutes (1 unit)/day

Outcome(s)

• Primary Outcome: Changes in the FMA upper-limb scor

Secondary Outcome

1) Changes in AOU and QOM of the MAL-14
2) Changes in components of the FMA upper-limb scale
3) Change in the ARAT score
4) Change in the MI
5) Change in the MAS score
6) Changes in the AROMs of the shoulder, elbow, forearm, wrist, and fingers
7) Change in the SIS score

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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)

Exclude criteria

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

Related Information

• Primary Sponsor: Domen Kazuhisa
• Secondary Sponsor: Hachisuka Kenji
• Source(s) of Monetary Support: Teijin Pharma Limited
• Secondary ID(s): UMIN000022509