Clinical study on the effectiveness and safety of rehabilitation training robots in the middle and late stages of brain injury in the training of lower limb motor function

A clinical study evaluating the effectiveness and safety of single lower limb rehabilitation training robot in patients with single lower limb motor dysfunction in the middle and late stages of brain injury

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068712

Enrollment

Unknown

Registered

2023-02-28

Start date

2023-02-28

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

Stroke

Interventions

Experimental group:Lower limb rehabilitation training robot

control group: routine rehabilitation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Understand the whole process of the trial, voluntarily participate and sign the informed consent form; (2) Age 18~75 years old, male and female; (3) Weight = 100kg, height 1.50m~1.90m; (4) Patients with single lower limb motor dysfunction caused by brain injury caused by various etiologies, including cerebral infarction, cerebral hemorrhage, brain trauma, etc.; (5) The course of the disease is within 3-12 months after the onset; (6) Stable vital signs, stable condition, tolerance of low-intensity sitting and standing training; (7) Patients with independent sitting balance, which can stand with the assistance of medical staff and single-limb robots; (8) The passive range of motion of the hip and knee joints is normal. (9) Have not participated in other clinical studies in the past 3 months; (10) Be willing to cooperate with the research requirements and be able to persist in rehabilitation.

Exclusion criteria

Exclusion criteria: (1) The range of motion of the joints is severely limited, and the walking movement is restricted (2) Skin damage or infection at the site of contact between the lower limb and the robot; (3) Serious internal medicine diseases; (4) Severe cognitive impairment, MMSE < 9 points, unable to cooperate with the completion of training; (5) Other contraindications or complications that may affect walking training; (6) Pregnant women, women planning to become pregnant or breastfeeding; (7) Those who have participated in any clinical trial within 1 month before enrollment; (8) Other circumstances in which the investigator believes that it is impossible to participate in clinical trials.

Design outcomes

Primary

Measure	Time frame
Fugl-Meyer Lower Extremity Function Scale;	—

Secondary

Measure	Time frame
Berg balance scale;Improved Barthel index;	—

Countries

China

Contacts

Public ContactLiu Lingyu

Shanghai Yangzhi Rehabilitation Hospital(Shanghai Sunshine Rehabilitation Hospital)

Happyneurologist@163.com15601865495

Outcome results

None listed

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