A Randomized Crossover Study to Investigate the Immediate Effects of FES Combined with Step Exercise Using ErigoPro in Patients with Chronic Post-stroke Hemiplegia

JRCT ID: jRCTs052210113

Registered date:27/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with hemiplegia of the lower limbs due to stroke who have been ill for at least 6 months.
• Date of first enrollment: 08/11/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

New treatment: Orthostatic loading with Erigo Pro and lower extremity step exercises combined with lower extremity electrical stimulation.
Standard treatment: Erigo Pro standing load and lower extremity step exercises.
Patients with chronic post-stroke hemiplegia whose symptoms are stable for more than 6 months after the onset of the disease will be enrolled and randomly assigned to Group A or Group B after obtaining written consent from the patient and determining eligibility during the screening period.
Group A: New treatment, washout period, standard treatment group
Group B: Standard treatment, washout period, new treatment

Outcome(s)

• Primary Outcome: Improvement of 10m walking speed

Secondary Outcome

Improvement of MAS (spasticity) of the paralyzed side of the lower limb.
Knee joint: extension and flexion, ankle joint: dorsiflexion and plantar flexion.
Increase in cadence (number of steps).
Improvement in Fugl-Meyer Assessment (FMA) lower extremity items (34-point scale).
Changes in Range of Motion (ROM)
Knee joint: flexion and extension; ankle joint: dorsiflexion (extension) and plantar flexion (flexion); foot: inward and outward bending.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible:
(1) Patients aged 20 years or older.
(2) Patients that had a stroke more than 6 months previously.
(3) Patients who are able to walk independently with or without the use of braces.
(4) Patients with at least one lower limb muscle with an MAS of at least 1 on the paralyzed side.
(5) Patients who can verbally express any complaints about adverse events.
(6) Patients who weigh 135 kg or less, are 210 cm or less in height, and have a leg length (plantar to greater trochanter; the projection at the top of the femur) of between 75 and 100 cm.
(7) Patients who do not have any unhealed fractures.
(8) Patients who have provided signed consent to participation.

Exclude criteria

Patients who meet any of the following criteria are ineligible.
1. Patients with a history of subarachnoid hemorrhage.
2. Patients with sub-tentorial lesions on head CT or head MRI at the time of stroke.
3. Patients who are unable to use the ErigoPro due to short stature or spinal problems caused by bone or cartilage dysplasia.
4. Patients with concomitant skin diseases (including allergic reactions) that may affect the harness, band fixation, or electrode placement.
5. Patients with a cardiac pacemaker, electrical stimulator, or implantable medical pump.
6. Patients who are pregnant.
7. Patients with uncontrollable pain.
8. Patients with a history of epilepsy.
9. Patients with bilateral extremities with MAS 1 or more.
10. Patients who have undergone stepping exercise with a robotic tilt table or FES for lower limbs within 1 week prior to enrollment.
11. Patients who received botulinum therapy for the lower limbs within 4 months prior to enrollment.
12. Patients with uncontrolled bradycardia or tachyarrhythmia.
13. Patients with uncontrolled hypotension or hypertension.
14. Patients with palpitations, shortness of breath, or chest pain at rest.
15. Patients with dizziness, cold sweat, or nausea in a sitting position.
16. Patients with a fever of 38 degrees or higher.
17. Patients with a resting oxygen saturation (SpO2) of 90% or less.
18. Patients with a respiratory rate of 30 breaths per minute or more.
19. Other patients who are considered ineligible by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Nishioka Yasuko