stroke
Conditions
Interventions
Intervention: 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 physi
Sponsors
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)First-ever hemiplegic patients 4 months after the stroke onset 2)Patients whose the lower extremity paralysis is estimated to be stage IV, V or VI according to the Brunnstrom stage 3)Patients whose spasticity of the plantar flexor muscle is estimated at 2 or less according to the Modified Ashworth Scale 4)Patients whose ankle dorsiflexion range of motion is 0 degree or more 5)Patients whose gait performance is estimated to be 5 or 6 according to the FAC 6)Patients who can understand the purpose and instructions of this study and complete the training 7)Patients who agree to participate in this study and provide their written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy 2)Patients who are contraindicated for the WA (e.g., patients with a metallic implant or implantable medical electrical equipment such as a cardiac pacemaker, and patients with a previous or suspected history of seizure) 3)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry 4)Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training 5)Patients who had fallen down within a week prior to the registry and are regarded to be at a high risk of falling down by an attending physician 6)Patients whose impairment severities changed between the prior and initial assessments *:Definition of an alteration (1)Brunnstorm stage for the lower extremity: Confirm whether the stages of the prior and initial assessments are the same value. If these stages are different, this is considered to be an alteration, and the patient with this alteration should be excluded from the study. (2)Lower extremity subscale of the Fugl-Meyer Assessment: Confirm whether the change in the score between the prior and initial assessments is 5 or less. If the change is 6 or more, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study. (3)Functional Ambulation Classification: Confirm whether the categories of the prior and initial assessments are the same value. If these categories are different, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study. 7) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 wearing neither the WA nor ankle-foot orthosis (AFO)before and after each intervention in the WA-asssisted training group (WA group) and usual training group (UT group). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Lower extremity subscale of the Fugl-Meyer Assessment 2)Muscle strength of the ankle dorsiflexor muscle 3)Ankle dorsiflexion range of motion 4)Modified Ashworth Scale for the plantar flexor muscle 5)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 wearing neither the WA nor AFO before and after each intervention in the WA and UT groups 6)Stroke Impact Scale 7)Adverse event assessment | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Ochi
University of Occupational and Environmental Health Department of Rehabilitation Medicine
Outcome results
None listed