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

NCT05883059 | Unknown

• 1 other identifier: PJ-KS-KY-2023-63(X)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Robotics

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline and 4 weeks

• 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.

  baseline and 4 weeks

• 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

  baseline and 4 weeks

Secondary Outcomes (3)

• Change from Baseline modified barthel index at 4 weeks

  baseline and 4 weeks

• Change from Baseline Gait parameters at 4 weeks

  baseline and 4 weeks

• Change from Baseline Minimum Mental State Examination at 4 weeks

  baseline and 4 weeks

Study Arms (2)

robot group

EXPERIMENTAL

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.

Device: Lower limb robot assisted walking training

control group

ACTIVE COMPARATOR

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

Other: routine rehabilitation

Interventions

Lower limb robot assisted walking training DEVICE

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.

robot group

routine rehabilitation OTHER

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

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• liuyong: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

yong liu

CONTACT

18098876656; fuwa52008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use of the tests.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physcician

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 31, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (1)