Electroacupuncture of Scalp Motor Area to Improve Post-Stroke Wrist Dyskinesia

NCT06208059 | Completed

• 1 other identifier: V1.1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the clinical efficacy of electroacupuncture and manual acupuncture in stimulating the scalp motor area for treating post-stroke wrist dyskinesia and its influence on the function of wrist movement-related active muscles. The main question it aims to answer is: which method of stimulating the scalp motor area is more effective in the recovery of wrist motor function after stroke? Participants will be given routine Western medicine treatment and acupuncture treatment on the hemiplegic side. In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side. The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. The score of Chinese Stroke Scale (CSS), the score of the upper limb of the Barthel Index (BI), the active range of motion (AROM) of wrist joint, and the surface electromyography (sEMG) was used to measure the root mean square (RMS) of extensor carpi radialis longus, extensor digitorum, flexor carpi radialis and flexor carpi ulnaris on the hemiplegic side of the patients before and after the 3-week treatment period, respectively compare the clinical efficacy of the two groups.

Conditions

Stroke Sequelae; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• Chinese Stroke Scale

  CSS comprehensively evaluated the neurological impairment of stroke patients from eight dimensions: level of consciousness, horizontal gaze, facial paralysis, speech, shoulder, hand, lower extremities and walking ability. the score ranged from 0 to 45. The higher the score, the more serious the neurological impairment.

  1 day before treatment and at the end of 3 weeks of treatment

Secondary Outcomes (3)

• the Barthel Index of ADL

  1 day before treatment and at the end of 3 weeks of treatment

• Active Range of Motion

  1 day before treatment and at the end of 3 weeks of treatment

• Root Mean Square

  1 day before treatment and at the end of 3 weeks of treatment

Other Outcomes (1)

• Clinical efficacy evaluation

  the end of 3 weeks of treatment

Study Arms (2)

manual acupuncture group

ACTIVE COMPARATOR

In the manual acupuncture group, participants will be needled in the scalp motor area on the lesion side and left in place for 30 minutes after obtaining qi. During needle retention, the needles will be intermittently twisted for 2min twice, with a frequency of about 200 r/min. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks.

Other: manual acupuncture

electroacupuncture group

EXPERIMENTAL

The same acupoint was selected as the manual acupuncture group in the electroacupuncture group. After obtaining qi, electroacupuncture stimulation will be applied using a continuous wave at a frequency of 2 Hz. The stimulation intensity will be adjusted based on the patient's tolerance, and each treatment will be lasted for 30 minutes. Participants will receive treatment once daily, with six consecutive days of treatment followed by one day of rest each week, for three weeks.

Other: electroacupuncture

Interventions

manual acupuncture OTHER

In manual acupuncture, the scalp motor area on the lesion side will be needled and left in place for 30 minutes after obtaining qi. During the needle retention, the needles will be twisted intermittently for 2 minutes twice, at a frequency of approximately 200 r/min.

manual acupuncture group

electroacupuncture OTHER

In electroacupuncture, the scalp motor area will be needled, and after obtaining qi, the treatment will involve applying electroacupuncture stimulation using a continuous wave with a frequency of 2 Hz. The intensity of the stimulation will be adjusted based on the patient's tolerance, and each treatment session will last for 30 minutes.

electroacupuncture group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with upper limb movement disorders who meet the diagnostic criteria for stroke;
• years old ≤ age ≤ 75 years old, gender is not limited;
• head MRI or CT scanning found responsible lesions;
• first onset of the disease, disease duration of 2 weeks to 6 months, stable condition, stable vital signs, conscious without unconsciousness;
• upper limb muscle strength on the affected side ≥ grade 3, wrist dorsiflexion muscle strength ≥ grade 2, wrist flexion muscle strength ≥ grade 2;
• no serious cardiac, pulmonary, or renal impairment;
• voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• a previous history of stroke or other brain disease;
• with severe mental retardation and/or severe aphasia that interferes with communication;
• with severe cardiac, pulmonary, and renal impairment in an unstable condition;
• inability to autonomously perform wrist flexion and extension movements on the hemiplegic side;
• neurological or musculoskeletal diseases affecting the recovery of limb function before the onset of the disease, with pre-existing abnormalities in bilateral wrist movements;
• allergy to adhesive tape, solid gel, etc.; bleeding tendency, acute suppurative inflammation, combined ulcers, infections, scars and tumors at acupuncture points and nearby areas; installation of pacemakers;
• transient ischemic attack, rebleeding after infarction, bilateral cerebral infarction, brain stem infarction, excessive cerebral hemorrhage or cranial defect;
• history of needle fainting or fear of needling.

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

MeSH Terms

Conditions

Movement Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Dongyan Wang, PhD

  The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: July 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: January 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)