Does the alternating timing of rTMS combined with soft-hand rehabilitation robot affect the recovery of hand function in patients after stroke? A study protocol for a multicentre randomised controlled trial.

Abstract

Combining repetitive transcranial magnetic stimulation (rTMS) with robotic training could result in more significant improvements in motor function than either treatment alone. The efficacy of this combination may depend on the sequencing of the interventions. However, few studies have explored the possibility of interleaving or alternating between the two treatment modalities within a single session or over a shorter time frame. The objective of this study is to evaluate the efficacy of alternating rTMS and soft-hand rehabilitation robot therapy to enhance upper limb and hand function in patients with ischaemic stroke. This multicentre study will be conducted as a single-blind, controlled, randomised trial, enrolling 132 post-stroke patients with a disease duration ranging from 1 week to 3 months. The study participants will be randomly assigned to group A (n=44), group B (n=44) and group C (n=44). All participants will undergo a 4-week neurological rehabilitation programme, which includes standardised physical and occupational therapy administered by experienced therapists. Group A will receive 10 Hz high-frequency rTMS (HF-rTMS) over the ipsilesional primary motor cortex (iM1) for 20 min, followed by 20 min of soft-hand rehabilitation robot training. Group B will receive 5 min of 10 Hz HF-rTMS over the iM1 followed by 5 min of soft-hand rehabilitation robot training, repeated four times. Group C will receive sham rTMS with other parameters identical to those of group A. The above treatments will be administered once daily, 5 days a week, for 4 weeks. The primary outcome measurement is the Fugl-Meyer assessment of upper extremity (FMA-UE). The secondary outcome measurements include the Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK), the Modified Ashworth Scale (MAS), and the International Classification of Functioning, Disability and Health upper extremity entries (ICF-Upper Extremity Entries). Assessments will be conducted at baseline and after 4 weeks of treatment. This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2024-SR-515). The findings of this study will be spread through networks of scientists, professionals and the general public, as well as peer-reviewed scientific papers and presentations at pertinent conferences. ChiCTR2400089583.