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

NCT ID: NCT05883059

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stroke Robotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use of the tests.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

robot group

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.

Group Type EXPERIMENTAL

Lower limb robot assisted walking training

Intervention Type 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.

control group

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

Group Type ACTIVE_COMPARATOR

routine rehabilitation

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lower limb robot assisted walking training

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 DEVICE

routine rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

liuyong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

liuyong

chief physcician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

yong liu

Role: CONTACT

Phone: 18098876656

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

liu yong

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

Identifier Type: -

Identifier Source: org_study_id