Effectiveness of outpatient rehabilitation treatment using the WelWalk for chronic stroke hemiplegia

JRCT ID: jRCTs042220066

Registered date:20/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 20/09/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Rehabilitation treatment combining gait training using WelWalk and exercise therapy for 60 minutes a day, twice a week for 10 weeks.

Outcome(s)

• Primary Outcome: Change in comfortable walking speed before and after intervention

Secondary Outcome

Changes in the following indexes before and after intervention, and from before intervention to 4 weeks after intervention
Comfortable gait speed, maximum gait speed
Six-minute walking distance
Spatio-temporal parameters for walking
Parameters of gait calculated by three dimentional motion analysis system
Timed up and go test
Change in comfortable walking speed before and after each intervention
Subjective assessment (Global rating of chance scales) after intervention and after 4 weeks of intervention.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who gave written consent to participate in this study from themselves or their proxy consents
2. Patients aged > 18 yo
3. Hemiplegic stroke patients eligible for outpatient treatment at the rehabilitation department of Fujita Health University Hospital
4. Patients more than 6 months after stroke onset
5. Patients who can walk independently or with supervision (regardless of the use of a walking aid)
6. Patients whose walking speed is 1.44 km/h or less
7. Patients weighing > 35 kg and < 100 kg
8. Patients > 140 cm and < 190 cm

Exclude criteria

1. Patients with a history of epileptic seizures within 3 months
2. Patients with symptomatic arrhythmias
3.Patients with pacemakers
4.Patients with uncontrolled hypertension (resting systolic BP > 180 mm Hg or diastolic BP > 120 mm Hg)
5.Patients with uncontrolled tachycardia (resting heart rate > 120 beats/min)
6.Patients with susceptible fractures of the legs or spine (such as severe osteoporosis)
7.Patients with ectopic ossification of the lower extremities leading to limited range of motion
8.Pregnant and possibly pregnant patients
9.Patients who have an infection and require isolation
10.When practicing wearing robot legs, patients who have difficulty wearing robot legs due to excessive or deformed lower limbs or pressure sores
11.Patients participating in intervention studies affecting other lower extremity/trunk movements and gait
12.Patients scheduled for antispasticity therapy with botulinum toxin preparations to the lower extremities during the study period
13.Patients with a change in walking speed greater than the minimum variable change (0.10 m/s) during the observation period before the start of the intervention
14.Other patients judged inappropriate by the attending physician, investigator, subinvestigator, or subinvestigator

Related Information

• Primary Sponsor: Otaka Yohei
• Source(s) of Monetary Support: TOYOTA MOTOR CORPORATION