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Effects of lower extremity rehabilitation robot on balance and walking ability improvement and brain remodeling mechanism in stroke patients

Effects of lower extremity rehabilitation robot on balance and walking ability improvement and brain remodeling mechanism in stroke patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047114
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Experimental group:Instruments replace part of routine rehabilitation training
Control group:Routine rehabilitation training treatment

Sponsors

Department of Rehabilitation Medicine of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years, male or female; 2.Subjects with stroke diagnosed by CT and/or MRI and clinical diagnosis with one side hemiplegia; 3.First onset, stable vital signs, course of disease: 2 weeks to 3 months; 4.FAC functional walking ability scale >= level 1; 5.Clear mind, cooperate with physical examination, and can accept movement instructions; 6.Subjects or their guardians can understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Brunnstrom stage of the affected lower limb > V; 2.Modified Ashworth Scale (hip, knee, ankle) of the affected side: any joint >= grade 3; 3.Severe heart disease, severe and uncontrollable hypertension, unstable angina attack, cardiac dysfunction grade III or above, acute myocardial infarction; 4.Local skin injury of lower limbs or local pressure ulcers; 5.A history of peripheral neuropathy; 6.A history of epilepsy, spinal cord injury, amputation, or severe lower limb joint disease; 7.Contraindication for the use of related products; 8.Major organ failure or other serious diseases (including malignant tumors; A history of severe mental illness; Active disseminated intravascular coagulation; Systemic metabolic diseases beyond control); 9.Female subjects with positive pregnancy test during pregnancy or lactation or screening; 10.Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment; 11.A history of drug abuse; 12.Known refusal or inability to comply with protocol requirements (including planned clinical visits and examinations) for any reason; 13.In the interest of the subjects, the investigator considers that they should not participate in other aspects of the clinical trial.

Design outcomes

Primary

MeasureTime frame
Cortical somatosensory evoked potentials and motor evoked potentials after treatment;After treatment, Fugl-meyer lower extremity motor function assessment scale score of lower extremity;Berg balance score after treatment;

Secondary

MeasureTime frame
Brunnstrom grading of the lower extremity;Holden walking function grading;Ashworth scale score for lower extremity improvement;Gait analysis test;Functional magnetic resonance imaging;

Countries

China

Contacts

Public ContactXu Jiang

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

xujiang@hust.edu.cn+86 13971083651

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026