Efficiency of Rehabilitation Robot with Functional Electrical Stimulation for Paraplegia

JRCT ID: jRCTs022220018

Registered date:02/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Paraplegic patients due to Spinal Disorder
• Date of first enrollment: 02/08/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Gait training rehabilitation using a robot with functional electrical stimulation

Outcome(s)

• Primary Outcome: AIS Lower Extremity motor score
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Kimura Ryota
• Source(s) of Monetary Support: Akita University Hospital