The Effects of the Control Strategies of Wearable Lower Limb Rehabilitation Robots

NCT ID: NCT07037849

Last Updated: 2025-06-26

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

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2027-04-22

Brief Summary

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

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.

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 Gait Training Gait Disorders

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Robot gait training group

During this study, we will explore which control strategy: Aware Hip Knee Coupling Control (AHKC), Passive control (PC), or fixed compliance control (FCC) may be optimal for post-stroke subjects

Group Type EXPERIMENTAL

Robot-assisted overground gait training

Intervention Type DEVICE

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers).

Interventions

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

Robot-assisted overground gait training

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers).

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

Stroke patients aged between 18 and 75 years. Patients who are medically stable and able to stand and walk independently for at least 10 meters during rehabilitation.

Stroke event occurred at least 3 months ago Patients with impaired lower limb motor function but with some degree of muscle activity in the lower extremities.

Patients without severe cognitive impairment and capable of understanding and following the treatment protocol.

Patients without severe balance or coordination disorders, able to maintain balance and perform gait training with assistive devices.

Patients without lower limb fractures or other serious skeletal issues affecting the lower limbs.

Patients without severe cardiovascular or other serious illnesses and able to tolerate the intensity and duration of rehabilitation therapy.

Patients willing to participate in the study and able to provide written informed consent.

Exclusion Criteria

Severe cognitive impairment that prevents the patient from understanding or complying with the treatment protocol.

Severe balance or coordination disorders that prevent the patient from maintaining balance and participating in gait training, even with assistive devices.

Other serious motor disorders, such as abnormal muscle tone or ataxia, which may interfere with the effectiveness of rehabilitation therapy.

Active cardiovascular disease or other serious systemic illnesses that may affect the patient's safety or treatment outcomes.

Lower limb fractures or other serious skeletal issues that may impact the suitability and safety of robot-assisted rehabilitation therapy.

Patients currently receiving other rehabilitation or experimental treatments. Patients with skin ulcers, infections, or other severe skin conditions that may interfere with the use and application of robotic devices.

Unexplained discomfort or pain symptoms that may limit the patient's ability to participate in rehabilitation therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Eighth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

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

Eight affiliated hospital, Sun Yat-Sen University

Shenzhen, Guangzhou, 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.

Shaofeng Zhao

Role: CONTACT

86 18898773680

Facility Contacts

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

Shaofeng Zhao

Role: primary

86 18898773680

Other Identifiers

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

202421602

Identifier Type: -

Identifier Source: org_study_id

U21A20136

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Robot Assisted Neuro-Rehabilitation
NCT01253018 COMPLETED PHASE1/PHASE2