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

NCT07037849 | Recruiting

• 2 other identifiers: 202421602U21A20136
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Gait Training; Gait Disorders

Keywords

Robots; Assistive robots; Trajectory; Torque; Force; Robot kinematics; Knee; Limb; Muscles; Hip

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test from baseline gait speed

  Gait speed will be assessed by instructing participants to walk at their maximum safe speed. Each participant will start 1 meter before the designated start line and continue walking until 1 meter past the finish line. The time taken to traverse the measured distance will be recorded using a stopwatch to the nearest one hundredth of a second.

  Baseline, immediately after intervention

Secondary Outcomes (1)

• Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE)

  Baseline, immediately after intervention

Study Arms (1)

Robot gait training group

EXPERIMENTAL

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

Device: Robot-assisted overground gait training

Interventions

Robot-assisted overground gait training 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).

Robot gait training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Eight affiliated hospital, Sun Yat-Sen University

Shenzhen, Guangzhou, 518033, China

RECRUITING

MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaofeng Zhao

CONTACT

86 18898773680; zhaosf1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 26, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): April 22, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-05

Locations

CN (1)