Stroke
Conditions
Interventions
Double-sham control group:Conventional rehabilitation (TAU) + sham contralesional plantar sensory electrical stimulation (PES) + sham contralesional PPC-TMS
Active PES + sham PPC-TMS group:TAU + active contralesional plantar PES + sham PPC-TMS
Active PPC-TMS + sham PES group:TAU + sham contralesional plantar PES + active contralesional PPC-TMS (iTBS)
Combined active PES + active PPC-TMS group:TAU + active contralesional plantar PES + active contralesional PPC-TMS (iTBS)
Sponsors
Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, any gender; 2. Imaging-confirmed stroke (ischemic/hemorrhagic) with unilateral hemiplegia; 3. Time since onset between 2 weeks and 6 months; 4. Stable vital signs, able to understand and cooperate with the assessment and training; 5. Voluntary participation and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications to TMS: history of epilepsy or high risk of seizures, intracranial metal foreign bodies/implanted electronic devices, cardiac pacemaker or other implanted stimulators, etc.; 2. Unstable vital signs or severe medical complications that may preclude completion of the treatment course; 3. Skin damage, infection, severe pain, or significant sensory abnormalities on the plantar surface of the non-paretic foot, making electrical stimulation intolerable or unsuitable; 4. Severe cognitive impairment, mental disorders, or significant aphasia that prevents cooperation with assessment and training; 5. Planned or ongoing receipt of other intensive neuromodulation therapies during the study period, where the dosage/frequency cannot be controlled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fugl–Meyer Assessment–Lower Extremity (FMA-LE) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Postural Assessment Scale for Stroke (PASS) score;Change in Berg Balance Scale (BBS) score;Change in Modified Barthel Index (MBI; lower-limb related) score;3D gait analysis: Change in peak knee flexion angle on the affected side; | — |
Countries
China
Contacts
Public ContactRong Bian
Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine
Outcome results
None listed