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

Eighth Affiliated Hospital, Sun Yat-sen University

Status: Enrolling

Conditions: Stroke; Gait Training; Gait Disorders

Treatments: Device: Robot-assisted overground gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT07037849

U21A20136 (Other Grant/Funding Number)

202421602

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Robot gait training group

Experimental group

Description:

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

Treatment:

Device: Robot-assisted overground gait training