NIPH Clinical Trials Search

Magnetic Stimulation-Assisted Rehabilitation for Shoulder Dysfunction after Neck Surgery: A Randomized Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Accessory nerve palsy
Date of first enrollment	28/05/2026
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	Intervention Group (Pathleader Group) Peripheral Magnetic Stimulation (Pathleader) add Standard Rehabilitation Duration 16-19 days. Frequency Once daily, 5 days per week (excluding weekends and public holidays). Session Time Approx. 40 minutes (15 min of exercise with magnetic stimulation add 20 min of other rehabilitation add vital signs, safety assessment, etc.). Magnetic Stimulation Parameters Stimulation Frequency 30 Hz. Stimulation Intensity In principle, the maximum intensity that does not cause pain or discomfort (up to 1.0 T). Intensity will be adjusted according to the discomfort of subjects. Specific Exercises 1. Scapular Adduction with Synchronized Magnetic Stimulation Scapular adduction exercises performed in synchronization with Pathleader stimulation of the trapezius muscle. Dosage 10 repetitions 5 sets (30-second rest between sets). 2. Shoulder Abduction with Synchronized Magnetic Stimulation Active (or active-assisted) shoulder abduction exercises performed in synchronization with Pathleader stimulation of the trapezius muscle. Dosage 10 repetitions 5 sets (30-second rest between sets). 3. Other Rehabilitation Standard rehabilitation provided by an occupational therapist. Control Group (Non-Pathleader Group) Standard Rehabilitation (without peripheral magnetic stimulation) Duration Frequency Same as the intervention group. Session Time Approx. 40 minutes (15 min of exercise without magnetic stimulation add 20 min of other rehabilitation add vital signs, safety assessment, etc.). Specific Exercises 1. Scapular Adduction Dosage 10 repetitions 5 sets (30-second rest between sets). Method Performed in the same posture and rhythm as the intervention group. 2. Shoulder Abduction Active (or active-assisted) shoulder abduction exercises performed without magnetic stimulation. Dosage 10 repetitions 5 sets (30-second rest between sets). Method Performed in the same posture and rhythm as the intervention group. 3. Other Rehabilitation Standard rehabilitation provided by an occupational therapist.

Outcome(s)

Primary Outcome

Rate of change in Compound Muscle Action Potential (CMAP) amplitude before and after the rehabilitation intervention during the study period.

Secondary Outcome

1. Functional Outcome Measures a) Rate of change in shoulder abduction Range of Motion (ROM) b) Rate of change in shoulder abduction muscle strength (MMT / HHD) c) Change in the scapula-spine distance d) Barthel Index (BI) 2. Patient-Reported Outcome Measures a) Rate of change in the Visual Analogue Scale (VAS) b) Shoulder Pain and Disability Index (SPADI) 3. Safety Outcome Measures Adverse events, Vital signs, and Fatigue levels

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	At Preoperative Evaluation (1)Diagnosis of head and neck cancer, regardless of the primary site. (2)Adult patients aged 18 years or older at the time of providing informed consent. (3)Patients scheduled to undergo neck dissection (either modified radical neck dissection or selective neck dissection). (4)Patients who have received a thorough explanation of the study, understood its content, and provided written informed consent. At Postoperative Evaluation (1)Patients with abnormal CMAP (less than 50% compared to the contralateral side) as identified by postoperative electrophysiological examination. (2)Patients with stable systemic postoperative status. (3)Patients capable of participating in a 19-day inpatient rehabilitation program.
Exclude criteria	At Preoperative Evaluation (1) Patients scheduled for bilateral neck dissection. (2) Patients scheduled for radical neck dissection. (3) Patients with a Performance Status (PS) score of 3 or higher (those requiring assistance with activities of daily living). (4) Medical history: Patients with pre-existing shoulder disorders (e.g., rotator cuff tear, frozen shoulder, or history of fractures). (5) Patients with pre-operative shoulder contracture. (6) Patients with a history of central nervous system (CNS) diseases. (7) Patients with neuromuscular diseases. (8) Patients requiring continuous systemic steroid administration. (9) Contraindications for magnetic stimulation: Patients with implanted medical devices (e.g., cardiac pacemakers, defibrillators, cochlear implants, or other metallic implants). (10) Patients with a history of epilepsy. (11) Patients who are pregnant or may be pregnant. (12) Patients judged by the investigator to be ineligible for study participation. At Postoperative Evaluation (1) Patients whose accessory nerve function is either well-preserved or completely lost after neck dissection: Mild cases: CMAP amplitude preserved at >= 50% compared to the contralateral side. Complete paralysis: No CMAP amplitude detected. (2) Patients with postoperative complications (e.g., wound infection, hemorrhage, fistula formation, or wound dehiscence). (3) Patients with other comorbidities that interfere with the protocol treatment. (4) Patients requiring additional treatment (e.g., reoperation) based on postoperative pathological diagnosis. (5) Patients judged by the investigator to be ineligible for study participation.