RATIONALE: The previous study resulted that the gait training using Functional Electrical Stimulation (FES) improved the ankle joint function and the walking ability for the chronic stroke patients with foot drop. In addition, the further exploratory study in multicenter obtained the result that the training with WA were especially good adaptation to the patients who have slight paralysis and can walk independently. PURPOSE: This multicenter prospective trial is studying to reveal whether the gait training with the WalkAide\[R\](WA) for chronic stroke patients who can walk independently is superior to gait training with a physical therapist.
OBJECTIVE: To reveal whether gait training with the WA for chronic stroke patients who can walk independently (Functional Ambulation Classification \[FAC\] 5 or 6) is superior to gait training with a physical therapist. OUTLINE: This is a multicenter study. Patients continue gait training with WA or without WA for 4 weeks. The effect of rehabilitation is evaluated by 6 Minute Walk Test without device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Thirty seven units (1 unit=20 minutes) of gait training with WA by a physical therapist for the WA group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
Thirty seven units of usual gait training by a physical therapist for the UT group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
Nagao Hospital
Fukuoka, Fukuoka, Japan
Hakujuji Hospital
Fukuoka, Fukuoka, Japan
Kitakyushu Abeyamakouen Hospital
Kitakyushu, Fukuoka, Japan
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Kitakyushu, Fukuoka, Japan
Tobata Rehabilitation Hospital
Kitakyushu, Fukuoka, Japan
Kitakyushu Yahata Higashi Hospital
Kitakyushu, Fukuoka, Japan
Shin-Oji Hospital
Kitakyushu, Fukuoka, Japan
Tochiku Hospital
Kitakyushu, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan
...and 14 more locations
6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
An evaluation of the effectiveness of WA-assisted gait training using the 6MWT without any device before and after each intervention in the WA-assisted training group (WA group) and usual training group (UT group).
Time frame: 4weeks
Lower extremity subscale of the Fugl-Meyer Assessment
An evaluation of the severity of lower extremity using the total score of lower extremity subscale of the Fugl-Meyer Assessment (perfect score: 34 points).
Time frame: 4weeks
Muscle strength of the ankle dorsiflexor muscle
An evaluation of the value(Newton/kg) using the ankle back flexor force of three times measured on average, divided by the weight value.
Time frame: 4weeks
Ankle dorsiflexion range of motion
An evaluation of range of motion (ROM) as the angle of the ankle succumbed back from the knee joint flexed position in the chair seat position (5 ° increments).
Time frame: 4weeks
Modified Ashworth Scale for the plantar flexor muscle
An evaluation of Modified Ashworth Scale (MAS) as the degree of muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) . The extent of MAS number indicating the muscle tone degree.
Time frame: 4weeks
10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).
An evaluation of the effectiveness of WA-assisted gait training using the 10MWT without any device before and after each intervention in the WA and UT groups.
Time frame: 4weeks
Stroke Impact Scale
An evaluation of summation score of the total score and physical domain (sixth domain) score.
Time frame: 4weeks
Adverse event assessment
A frequency counting of the adverse events. LLT code will be assigned to the reported adverse event using the MedDRA dictionary. The origin date of the term until adverse events define the start date of the protocol treatment.
Time frame: 4weeks
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