Clinical trial NCT05883059: Clinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke
Official title: Clinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
Robotics
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Berg Balance Scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline functional ambulation category scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline fugl-meyer assessment-lower extremity at 4 weeks
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change from Baseline modified barthel index at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Gait parameters at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Minimum Mental State Examination at 4 weeks
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
References: