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Research on the Rehabilitation Efficacy and Safety of Acupuncture Treatment Combined with Intermittent Theta Burst Stimulation (iTBS) for Upper Limb Motor Dysfunction in Stroke Patients: A Multicenter Randomized Controlled Trial.

Research on the Rehabilitation Efficacy and Safety of Acupuncture Treatment Combined with Intermittent Theta Burst Stimulation (iTBS) for Upper Limb Motor Dysfunction in Stroke Patients: A Multicenter Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000280
Enrollment
Unknown
Registered
2025-02-16
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Upper limb dysfunction after stroke.

Interventions

Group A (iTBS Group):Routine rehabilitation therapy (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), iTBS
Group B (acupuncture group):Routine rehabilitation treatment (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), acupuncture treatment
Group C (iTBS and acupuncture combined group):Routine rehabilitation treatment (including comprehensive training of hemiplegic limbs, electronic biofeedback, occupational therapy), acupuncture treatme

Sponsors

Shangluo Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Having the first onset of stroke and conforming to the WHO Stroke Diagnosis and Treatment Guidelines as well as the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014" released in 2015 which have been confirmed by cranial CT or MRI imaging scans. 2) The course of the disease being more than 2 weeks and less than 12 months. 3) Having a stable condition after brain injury. 4) Being aged between 18 and 85 years old. 5) Having upper limb motor dysfunction. 6) Having a clear consciousness good cardiopulmonary function stable vital signs and being able to cooperate well with the training. 7) Promising to abide by the research procedures and cooperate with the implementation of the whole research process. 8) Promising to comply with the precautions regarding lifestyle during the research period. 9) Having the Brunnstrom assessment of the affected upper limb and hand at or above grade II. 10) Being willing to sign the informed consent form for this research.

Exclusion criteria

Exclusion criteria: 1) Those accompanied by disorders of consciousness or cognitive dysfunction mixed aphasia etc. that may affect assessment and treatment. 2) Those with excessive muscle tone at Ashworth grade III and upper limb muscle strength less than grade 2. 3) Those with major diseases such as combined dysfunction of important organs like the liver kidneys and heart. 4) Those with a past history of severe upper limb joint diseases (such as tumors fractures etc.). 5) Those with an implanted cardiac pacemaker or other metal medical devices implanted intracranially. 6) Those with severe stroke attacks. 7) Pregnant or lactating women. 8) Those with cranial bone defects. 9) Any condition that in the opinion of the researcher may harm the subjects or cause them to be unable to meet or execute the research requirements.

Design outcomes

Primary

MeasureTime frame
Wolf Motor Function Test WMFT;

Secondary

MeasureTime frame
Modified Barthel Index, MBI;The Upper Extremity Section of the Modified Ashworth Scale, MASUE;Stroke-specific Quality of Life scale,SS-QOL;Fugl-Meyer Assessment Upper Extremity Scale,FMA-UE;Action Research Arm Test,ARAT;

Countries

China

Contacts

Public ContactJia Yao

Shangluo Central Hospital

501925133@qq.com+86 151 2949 9218

Outcome results

None listed

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