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NCT Number: NCT07037849

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders Gait Training Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eight affiliated hospital, Sun Yat-Sen University

Shenzhen, Guangzhou, 518033, China

Location status: Recruiting

Location contact

Chuyao Jian

PRINCIPAL_INVESTIGATOR

Shaofeng Zhao

CONTACT

[email protected]

86 18898773680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Failure to meet other specific inclusion criteria outlined in the study protocol.

Treatment and study plan

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).

Primary outcomes

  1. Change in 10 Meter Walk Test from baseline gait speed

    Time frame: Baseline, immediately after intervention

    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.

Secondary outcomes

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

    Time frame: Baseline, immediately after intervention

    The Lower Extremity Fugl-Meyer Assessment (FMA-LE) is a validated, performance-based scale used to evaluate motor function, reflexes, coordination, and movement synergy of the lower limb in stroke patients. The FMA-LE consists of 17 items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a total possible score ranging from 0 to 34. Higher scores indicate better lower limb motor function. Assessments will be performed by trained evaluators according to standardized procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Shaofeng Zhao

CONTACT

[email protected]

86 18898773680

Sponsors and collaborators

Lead sponsor

Eighth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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