Lower limb motor dysfunction after stroke
Conditions
Interventions
Study 1 iTBS group:Intermittent Theta Burst Stimulation (iTBS) combined with conventional treatment
Study 1 Sham Stimulation Group:Pseudotranscranial magnetic stimulation combined with conventional therapy
Study 2:Each stroke subject received three different TBS regimens (cTBS+iTBS
sham cTBS+iTBS
The random order of sham cTBS+sham iTBS. There is no interval between cTBS preprocessing and subsequent iTBS, and TBS intervention is performed every week.
Study 3 cTBS + iTBS + Robotics training group:Continuous ? short burst pulse stimulation (cTBS) + intermittent ? short burst pulse stimulation (iTBS)+Robotics training
Study 3 cTBS + iTBS + Robotics training group:Sham Continuous ? short burst pulse stimulation (cTBS) + intermittent ? short burst pulse stimulation (iTBS)+Robotics training
Study 3 Sham cTBS + Sham iTBS + Robotics Training Group:Sham Continuous ? short burst pulse stimulation (cTBS) + Sham intermittent ? short burst pulse stimulation (iTBS)+Robotics training
Sponsors
Jiangsu Medical College/ Yancheng NO.1 People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) and diagnosed with stroke by CT or MRI; (2) Age 40-80 years old; (3) Stable condition, first onset of illness, duration of illness 1-3 months; (4) Able to walk independently or with assistance for more than 10 metres, Brunnstrom stage III-V lower limb; (5) Cognitive clarity, ability to follow simple verbal commands or instructions, Moca score greater than 26; (6) Informed consent signed by the patient or his/her relatives. (7) No history of epilepsy; (8) No contraindications to TMS examination.
Exclusion criteria
Exclusion criteria: (1) Individuals with relevant contraindications to TMS (pacemakers, intracranial implants, implanted drug pumps or pregnancy, etc. (2) Significant speech, attention, auditory, visual (lateral neglect, hemianopsia, etc.), intellectual, psychiatric or cognitive dysfunction; (3) Prior history of organic brain disease, neuropsychiatric history, drug abuse and alcoholism; (4) Severe heart, lung, liver, kidney and other vital organ failure or lower limb motor dysfunction prior to stroke; (5) Individuals with severe cognitive or communication disorders; (6) Those who are currently participating in other clinical trials. (7) Those who cannot co-operate with the functional assessment and have poor compliance. (8) Inability to induce a TMS response in the tibialis anterior muscle prior to formal testing; (9) Pregnancy; (10) Use of drugs that affect cortical excitability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10-meter walking speed(Study 1);Motor Evoked Potential (MEP) Amplitude(Study 2);Fugl-Meyer Assessment of Motor Function (Lower Extremity) (FMA-LE) (Study 3); | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-Dimensional Gait Analysis(Study 1);Fugl-Meyer Assessment of Motor Function (Lower Extremity) (FMA-LE)(Study 1);30-Second Sit-to-Stand Test(Study 1);Functional Near-Infrared Spectroscopy(Study 1);Barthel Index (BI)(Study 1);Berg Balance Scale (BBS)(Study 1);Time Up and Go Test (TUGT)(Study 1);Balance Instrument Analysis(Study 1);Resting Motor Threshold (rMT)(Study 2);MEP Response Classification(Study 2);Active Motor Threshold (aMT)(Study 2);Functional near infrared testing (Study 3);Three-Dimensional Gait Analysis (Study 3);Electroencephalogram (EEG) (Study 3);Modified Barthel Index (MBI) (Study 3);Postural Assessment Scale for Stroke (PASS) (Study 3);Lower Limb Surface Electromyography (sEMG) (Study 3);Motor Evoked Potential (MEP) (Study 3); | — |
Countries
China
Contacts
Public ContactSu Bin; Zhou Ya
Jiangsu Medical College/ Yancheng NO.1 People's Hospital
Outcome results
None listed