The Effects of the Control Strategies of Wearable Lower Limb Rehabilitation Robots
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted overground gait training.
- Who it may be relevant to
- Registry conditions: Stroke, Gait Training, Gait Disorders. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Control Strategies in Wearable Lower Limb Rehabilitation Robots
Overview
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.
Interventions
- Device 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).
Primary outcome measures
- Change in 10 Meter Walk Test from baseline gait speed [Time frame: Baseline, immediately after intervention]
Secondary outcome measures (1)
- Change scores of Lower Extremity Fugl-Meyer Assessment (FMA-LE) [Time frame: Baseline, immediately after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Eight affiliated hospital, Sun Yat-Sen University — Shenzhen
Identifiers
NCT: NCT07037849 · 202421602 · U21A20136