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Cerebellar earthworm iTBS combined with task-oriented robotics for recovery of lower limb motor function in subacute stroke: a randomized, single-blind, controlled study

Study on the application of brain-computer interaction rehabilitation training system with gait robot in gait recovery of hemiplegic patients with stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105631
Enrollment
Unknown
Registered
2025-07-08
Start date
2023-02-15
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Stroke

Interventions

one control group:Routine rehabilitation training
two brain unit group:Combination of brain-computer interaction training with conventional rehabilitation on the basis of conventional training
three robot group:Combining gait robotics training with regular training
four joint group:Combining brain-computer interaction and gait training robots based on conventional training

Sponsors

Shandong Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stroke formulated by the Fourth Academic Conference on Cerebrovascular Disease and confirmed by cranial CT or MRI; 2. First-ever onset of the disease, age 18-75 years old, with a unilateral lesion and a duration of 2 weeks-3 months; 3. No cognitive dysfunction, normal Mini-Mental State Examination (MMSE) (illiterate>=17 points, primary>=20 points, secondary>=24 points); 4. Lower limb muscle tone of the affected side (Modified Ashworth Scale (MAS) = Grade 3; 5.Passive range of motion of the hip and knee joints of the affected side is generally normal (limitation <= 15°), and the ankle joints can be kept in a neutral position; 6. Signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Lower limb dysfunction on the affected side due to other diseases prior to stroke; 2. Vestibular or cerebellar dysfunction; 3. Accompanied by severe speech, visual (e.g., unilateral neglect, hemianopsia, etc.), and sensory deficits; 4. Skin lesions or infections of the lower limbs and the robotic wear contact area, and weighing more than 100 kg; 5. Worsening of the condition or other comorbidities limiting activity; 6. Intracranial metallic implants, wearing a metal pacemaker, or the patient has a defective skull.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Lower Extremity;

Secondary

MeasureTime frame
Berg Balance Scale;Modified Barthel Index;Functional near-infrared spectroscopy;

Countries

China

Contacts

Public ContactHu Chuan

Shandong Third Hospital

hchhujin@163.com+86 133 0541 0825

Outcome results

None listed

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