Ankle joint motion training using a lower limb exoskeleton robot

JRCT ID: jRCT1032210357

Registered date:01/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 01/10/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Rehabilitation using a lower limb exoskeleton robot for 40 minutes per day for 10 days.

Outcome(s)

• Primary Outcome: Ankle spasticity, motor function (motor paralysis severity and muscle strength)
• Secondary Outcome: Motion analysis (ankle joint angle during walking), active Range Of Motion (ROM), surface electromyogram, floor reaction force meter

Key inclusion & exclusion criteria

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

Include criteria

Stroke patients
Hemiplegia due to unilateral cerebral hemisphere lesion
Age: 18 years and older
Lower limb motor impairment, SIAS(foot pat) 1 or greater
Ankle dorsiflexion range of motion is 0 degrees or greater.
Patients who do not have severe aphasia or cognitive impairment and can understand the purpose of the study.
Patients with no contraindication to exercise therapy.

Exclude criteria

Examples of contraindications to exercise therapy (details are given below)
1) Serious cardiac disease: unstable angina, myocardial infarction of short duration, non-compensated congestive heart failure, acute pulmonary heart, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis, endocarditis, etc.
2) Poorly controlled hypertension
(iii) Acute systemic illness or fever
(iv) Recent pulmonary embolism, acute pulmonary heart, severe pulmonary hypertension
5) Complication of severe hepatic or renal dysfunction
(6) Complication of severe orthopedic disease that interferes with lower limb movement
7) Severe cognitive impairment, severe psychiatric disease
(viii) Other metabolic disorders (e.g., acute thyroiditis)
(9) Patients with spontaneous pain or inflammation of the ankle joint
Patients with a history of ankle fracture or traumatic tendon injury.
Patients with contractures of the ankle joint
Patients with impaired consciousness
(9) Patients for whom written consent could not be obtained

Related Information

• Primary Sponsor: Michiyuki Kawakami
• Source(s) of Monetary Support: CYBERDYNE