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

Phase 3

• Conditions: Patients with hemiplegia of the lower limbs due to stroke who have been ill for at least 6 months.; Stroke, Hemiplegia; Tree Number(s): C10.597.622.295, C23.888.592.636.312 MeSH Unique ID: D006429

• Registration Number: JPRN-jRCTs052210113
• Lead Sponsor: ishioka Yasuko

Brief Summary

The FES group of post-stroke hemiplegic patients in the chronic phase who underwent a combination of step exercise and lower limb muscle electrical stimulation using ErigoPro significantly increased their 10 m walking speed compared to the standard treatment group who underwent only step exercise.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-27
• Study Completion: 2022-02-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified