Back to resultsClinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lower limb robot assisted walking training
routine rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, Robotics
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.
Sites / Locations
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
robot group
control group
Arm 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.
Routine rehabilitation therapy includes lower limb muscle strength training, stretching training, joint range of motion training, balance training, walking training, and functional electrical stimulation.
Outcomes
Primary Outcome Measures
Change from Baseline Berg Balance Scale at 4 weeks
The Berg Balance Scale is a commonly used scale for evaluating balance ability in stroke Participants.Participants cooperate to complete the corresponding projects, and specialized assessors with professional knowledge in rehabilitation assessment will score based on the patient's completion status. The scale has a total of 14 items, including standing up from a sitting position, standing to sitting, standing independently, sitting independently, bed to wheelchair transfer, standing with eyes closed, standing with feet together, standing with upper limbs extended forward, standing with objects picked up from the ground, turning back to look, turning around for a week, alternating steps with both feet, standing with both feet in front of and behind, and standing with one leg. Each project has a maximum score of 4 and a ，minimum score of 0. The higher the score, the better the balance ability.
Change from Baseline functional ambulation category scale at 4 weeks
The functional ambulation category scale is a commonly used scale for evaluating walking ability, with ratings ranging from 0 to 5. The higher the level, the better the walking ability.
Change from Baseline fugl-meyer assessment-lower extremity at 4 weeks
The scale assesses the presence or absence of reflexes in the participants' lower limbs, as well as the presence of hyperreflexia, flexor coordination, extensor coordination, activities accompanied by coordination, activities without coordination, and speed.The higher the score, the better the lower limb motor ability
Secondary Outcome Measures
Change from Baseline modified barthel index at 4 weeks
The evaluators rated participants on items such as grooming, bathing, eating, toileting, dressing, bowel control, urination control, going up and down stairs, bed and chair transfer, and walking on level ground. The higher the score, the better the daily living ability.
Change from Baseline Gait parameters at 4 weeks
Use a gait analysis device to measure the patient's walking speed, stride frequency, stride length, and stride length. The linear distance traveled in the direction of travel per unit time during walking at a pace. Step frequency refers to the number of steps taken per minute during walking. Step length refers to the distance traveled by one foot following the ground during walking to the next foot following the ground. When walking, the distance traveled from one foot following the ground to another heel landing on that side.
Change from Baseline Minimum Mental State Examination at 4 weeks
This scale is a commonly used scale for evaluating participants' cognitive status. Participants are required to answer the corresponding questions or complete the corresponding actions according to the instructions. If the answer is correct or the corresponding actions are completed, 1 point will be awarded, otherwise no point will be awarded. The total score is 30 points, and the higher the score, the better the cognitive ability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05883059
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
liuyong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use of the tests.
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robot group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Lower limb robot assisted walking training
Intervention Description
The participants in the robot group received lower limb robot assisted walking training combined with routine rehabilitation therapy. Lower limb robot assisted walking training for 30 minutes each time, once a day, 5 times a week, for 4 consecutive weeks; Routine rehabilitation treatment includes lower limb muscle strength training, stretching training, joint range of motion training, balance training, walking training, functional electrical stimulation, etc. Routine rehabilitation treatment once a day, five times a week, for four consecutive weeks.
Intervention Type
Other
Intervention Name(s)
routine rehabilitation
Intervention Description
The control group participants received routine rehabilitation, including lower limb muscle strength training, stretching training, joint range of motion training, balance training, walking training, functional electrical stimulation, etc. Routine rehabil
Primary Outcome Measure Information:
Title
Change from Baseline Berg Balance Scale at 4 weeks
Description
The Berg Balance Scale is a commonly used scale for evaluating balance ability in stroke Participants.Participants cooperate to complete the corresponding projects, and specialized assessors with professional knowledge in rehabilitation assessment will score based on the patient's completion status. The scale has a total of 14 items, including standing up from a sitting position, standing to sitting, standing independently, sitting independently, bed to wheelchair transfer, standing with eyes closed, standing with feet together, standing with upper limbs extended forward, standing with objects picked up from the ground, turning back to look, turning around for a week, alternating steps with both feet, standing with both feet in front of and behind, and standing with one leg. Each project has a maximum score of 4 and a ，minimum score of 0. The higher the score, the better the balance ability.
Time Frame
baseline and 4 weeks
Title
Change from Baseline functional ambulation category scale at 4 weeks
Description
The functional ambulation category scale is a commonly used scale for evaluating walking ability, with ratings ranging from 0 to 5. The higher the level, the better the walking ability.
Time Frame
baseline and 4 weeks
Title
Change from Baseline fugl-meyer assessment-lower extremity at 4 weeks
Description
The scale assesses the presence or absence of reflexes in the participants' lower limbs, as well as the presence of hyperreflexia, flexor coordination, extensor coordination, activities accompanied by coordination, activities without coordination, and speed.The higher the score, the better the lower limb motor ability
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline modified barthel index at 4 weeks
Description
The evaluators rated participants on items such as grooming, bathing, eating, toileting, dressing, bowel control, urination control, going up and down stairs, bed and chair transfer, and walking on level ground. The higher the score, the better the daily living ability.
Time Frame
baseline and 4 weeks
Title
Change from Baseline Gait parameters at 4 weeks
Description
Use a gait analysis device to measure the patient's walking speed, stride frequency, stride length, and stride length. The linear distance traveled in the direction of travel per unit time during walking at a pace. Step frequency refers to the number of steps taken per minute during walking. Step length refers to the distance traveled by one foot following the ground during walking to the next foot following the ground. When walking, the distance traveled from one foot following the ground to another heel landing on that side.
Time Frame
baseline and 4 weeks
Title
Change from Baseline Minimum Mental State Examination at 4 weeks
Description
This scale is a commonly used scale for evaluating participants' cognitive status. Participants are required to answer the corresponding questions or complete the corresponding actions according to the instructions. If the answer is correct or the corresponding actions are completed, 1 point will be awarded, otherwise no point will be awarded. The total score is 30 points, and the higher the score, the better the cognitive ability.
Time Frame
baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yong liu
Phone
18098876656
Email
fuwa52008@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liu yong
Phone
18098876656
Email
fuwa52008@126.com
12. IPD Sharing Statement
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Clinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke
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