Unique ID issued by UMIN | UMIN000034191 |
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Receipt number | R000038971 |
Scientific Title | Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke |
Date of disclosure of the study information | 2018/09/18 |
Last modified on | 2019/09/22 17:09:21 |
Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke
Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke
Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke
Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke
Japan |
stroke
Rehabilitation medicine |
Others
NO
This study investigated the efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy using ReoGo-J for subacute patients with upper limb paralysis after stroke
Safety,Efficacy
Exploratory
Fugl-Meyer Assessment(FMA)Upper extremity section
Each outcome is evaluated at baseline(before any rehabilitation), after 3-week, after 6-week(after any rehabilitation)
Upper-limb/Finger Brunnstrom stage
Simple test for evaluation hand function(STEF)
pain:100mm Visual analogue scale(VAS)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
We provide Modified Constraint-Induced Movement Therapy(Modified CIMT) and self-training using ReoGo-J during six weeks for patients with upper limb paralysis after stroke. Each treatment is provided for 40 minutes a day and 5 days per week. Modified CIMT is composed of task-oriented therapy and transfer package.
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1)Clinically incipient stroke patients with upper-limb hemiplegia
(2)Patients who experienced a stroke in the previous 4 to 8 weeks 4.
(3)Upper-limb(shoulder/elbow)Brunnstrom stage III or IV at the time of providing informed consent
(4) Age between 20 and 80 years at the time of providing informed consent
(5) Patients who can do self-care themselves at a sitting position
(1)Brainstem stroke
(2)Vision disorders
(3)Subarachnoid hemorrhage
(4)Severe aphasia
(5)Mini-mental state examination less than 24 points
(6) Inability to remain seated during training
(7) Intense pain in response to external pressure on affected upper limb
(8) Incapable of voluntary consent
(9) Previous experience with robotic rehabilitation of upper-limb hemiplegia
(10) Previous experience with constraint-induced movement therapy of upper-limb hemiplegia
(11) Previous experience with functional electrical stimulation(FES)therapy of upper limb hemiplegia
(12) Cardiac or respiratory disorders that may interfere with rehabilitation
(13) Other neuromuscular diseases
(14) Body weight of 110 kg or more
(15) Other reasons deemed by the investigators or subinvestigators to render the subject unsuitable for treatment with the investigational device
15
1st name | Naoya |
Middle name | |
Last name | Anmoto |
Nagoya city rehabilitation agency
Division of occupational therapy
4678622
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
052-835-3811
ot-dep@nagoya-rehab.or.jp
1st name | Naoya |
Middle name | |
Last name | Anmoto |
Nagoya city rehabilitation agency
Division of occupational therapy
4678622
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
052-835-3811
ot-dep@nagoya-rehab.or.jp
Nagoya city rehabilitation agency
Nagoya city rehabilitation agency
Other
Japan
Nagoya city rehabilitation agency
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
052-835-3811
soumubu@nagoya-rehab.or.jp
NO
名古屋市総合リハビリテーショ事業団(愛知県)
2018 | Year | 09 | Month | 18 | Day |
Unpublished
11
Completed
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 05 | Month | 26 | Day |
2017 | Year | 06 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 18 | Day |
2019 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038971
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