臨床研究等提出・公開システム

Clinical Efficiency of "Akita Trainer", a Gait Rehabilitation Robot with Functional Electrical Stimulation for Paraplegic patients due to Spinal Disorder

Efficiency of Rehabilitation Robot with Functional Electrical Stimulation for Paraplegia

Kimura Ryota

Akita University Graduate School of Medicine

1-1-1, hondo, Akita city, Akita

rkimura@med.akita-u.ac.jp

Kimura Ryota

Akita University Graduate School of Medicine

1-1-1, hondo, Akita city, Akita

+81-18-884-6148

rkimura@med.akita-u.ac.jp

Recruiting

Aug. 02, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Paraparesis patient due to spinal disorder
Patients inability to walk unaided (including supportive gait) due to spinal cord injury caused by acute or chronic central nervous system disorder (traumatic spinal cord injury, myelopathy, metastatic spinal tumor, etc.). Patients with spasticity of the lower limbs. If the patient requires surgery, it should be performed after the drain is removed and the attending physician judges that rehabilitation can be started. If orthostatic hypotension is observed in the acute phase, it should be performed at least when the patient can sit up in a stretcher-type wheelchair.
2) Recognize the significance of this research and participate in the research of their own free will.
3) Persons who have given written consent after explanations in the consent explanatory document.
The basis for setting the number of subjects was the number of possible subjects within the study period.

1) Patients who may not be able to follow the instructions of the therapist
Persons with severe sensory aphasia, Persons with severe higher brain dysfunction
2) Persons for whom exercise load may lead to deterioration of physical condition
Poorly-controlled hypertension (systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 100 mmHg or higher), Poorly-controlled hypertension (systolic blood pressure of 180 mmHg or more or diastolic blood pressure of 100 mmHg or more), Resting heart rate of 100/min or more, Restricted exercise due to impairment of cardiac or respiratory function
3) Patients with impaired blood circulation in the lower limbs or diabetic peripheral neuropathy
4) Patients with severe joint contracture or deformity
5) Patients who have other limitations of movement for some reason.
6) Patients who may have incontinence that may contaminate the robot.
7) Contraindication for electrical stimulation by FES
Poorly-controlled cardiovascular disease, Patients with cardiac pacemakers, Arterio-venous thrombosis, thrombophlebitis, Easy bleeding at the site of irritation, Skin damage and skin lesions at the stimulation site, Local disorders such as fracture, dislocation, etc

Both

Paraplegic patients due to Spinal Disorder

Gait training rehabilitation using a robot with functional electrical stimulation

Paraplegia, Spinal disorder, Spinal cord injury

Robot rehabilitation, Functional electrical stimulation

D000066530

AIS Lower Extremity motor score

SCIM(Spinal Cord Independence Measure: SCIM), Short Form-36, Muscle thickness(Femur, calf, upper arm, diaphragm), Ratio of Thickness of quadriceps femoris and Girth of femur, Modified Ashwarth Scale, Questionnaire for implementation of gait training rehabilitation robot (evaluation of satisfaction, fatigue, motivation, etc.), Earlobe blood flow, Torque values applied to hip and knee joint

+81-18-884-6461

June. 30, 2022

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