Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke

Erenköy Physical Therapy and Rehabilitation Hospital

Status: Completed

Conditions: Stroke

Treatments: Other: robot-assisted gait training; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03565185

ErenkoyPTRH

Details and patient eligibility

About

Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

Full description

There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rehabilitation need for stroke
• Patients under FAC stage 4
• No contraindications for robotic rehabilitation
• Subacute stroke

Exclusion criteria

• The robot-orthosis does not fit the patient's body
• Inadequate body weight (obesity)
• Severe contractures
• Bone instability (nonstable spinal cord fracture and severe osteoporosis)
• Circulation problems
• Cardiac problems
• Open wounds on the lower extremities or in the body where they will come into contact with the orthosis
• Uncoordinated, psychotic or aggressive patients
• Serious cognitive disorders
• Patients with long-term infusion therapy
• Hip, knee, ankle arthrodesis
• Epilepsy
• Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia
• Those with severe vascular problems of the lower extremity
• Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases
• Severe respiratory diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 3 patient groups, including a placebo group

End-effector

Active Comparator group

Description:

For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training(end-effector type-Lokohelp) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Treatment:

Other: robot-assisted gait training

Exoskeleton

Active Comparator group

Description:

For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training (exoskeleton type-Robogait) will be taken with 45 minutes a day for 3 days a week for 4 weeks. Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Treatment:

Other: robot-assisted gait training

conventional treatment

Placebo Comparator group

Description:

conventional treatment methods for stroke rehabilitation 5 days a week Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Treatment:

Other: placebo