Clinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke

liuyong

Status: Enrolling

Conditions: Stroke

Treatments: Other: routine rehabilitation; Device: Lower limb robot assisted walking training

Study type: Interventional

Funder types: Other

Identifiers

NCT05883059

PJ-KS-KY-2023-63(X)

Details and patient eligibility

About

The goal of this clinical trial is to learn about effect of lower robot in stroke population. The main question[s] it aims to answer are: the efficacy of lower limb robot assisted training in improving walking ability, lower limb function, cognition, and quality of life in stroke patients.The robot group of patients received lower limb robot assisted training combined with routine rehabilitation treatment. The control group only received routine rehabilitation treatment.Compare two groups to explore the therapeutic effect of lower limb robots on lower limb dysfunction after stroke.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• In line with the diagnostic criteria for stroke in the Diagnostic Criteria for Various Cerebrovascular Diseases issued by the Chinese Medical Association in 2019.
• First stroke or no residual dysfunction after previous stroke.
• Participants have stable vital signs, clear consciousness, and no aphasia.
• The onset time of stroke is between 2 weeks and 6 months after onset.
• Age>18 years old.
• Presence of hemiplegic motor dysfunction.
• Ability to walk with the help of a single person.
• sign an informed consent form with the Participants or family member before treatment.

Exclusion criteria

• Participants have serious musculoskeletal or other mental nervous system disease.
• Participants have contraindications to cardiovascular exercise.
• Moderate to severe contracture of the patient's lower limbs (modified Ashworth scale, MAS>2 for ankle, knee, or hip joints).
• Presence of progressive or secondary brain injury leading to unstable condition.
• Unilateral neglect or diseases that affect vision.
• Participants have lower limb vein thrombosis.
• Participants present with lower limb non healing ulcers and osteoporosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

robot group

Experimental group

Description:

The participants in the robot group received lower limb robot assisted walking training combined with routine rehabilitation therapy. Routine rehabilitation therapy includes lower limb muscle strength training, stretching training, joint range of motion training, balance training, walking training, and functional electrical stimulation.

Treatment:

Device: Lower limb robot assisted walking training

control group

Active Comparator group

Description:

Routine rehabilitation therapy includes lower limb muscle strength training, stretching training, joint range of motion training, balance training, walking training, and functional electrical stimulation.

Treatment:

Other: routine rehabilitation