Effect of Cerebellar Fastigial Nucleus Stimulation Combined With Sling Exercise on Motor Function in Hemiplegic Stroke Patients

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A vizsgálat 18 és 70 év közötti felnőtteket keres, akiknek az elmúlt 6 hónapban kezdődött agyi érkatasztrófa (sztrók) után a test egyik oldala le van gyengülve.

Életkor

18 és 70 év között

Nem

Férfiak és nők

A betegség stádiuma

Sztrók utáni féloldali bénulás (hemiplégia), a betegség kezdete az elmúlt 6 hónapon belül. Eszméletén van, a létfontosságú jelei és az érzelmi állapota stabil.

A részvétel fő kizáró okai

• Súlyos szív-, tüdő-, máj- vagy vesebetegség
• Súlyos ízületi betegség, nem teljesen összeforrt csonttörés vagy súlyos csontritkulás
• Elmebetegség, vagy súlyos gondolkodási, látási vagy hallási nehézség, ami miatt nem tudja követni az utasításokat
• Egyidejű egyensúlyszervi (vesztibuláris) probléma
• Epilepszia vagy fémtárgy a koponyában

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• 18 és 70 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

This study aims to investigate the rehabilitative effects and synergistic potential of combining Fastigial Nucleus Stimulation (FNS) with Sling Exercise Training (SET) on motor function in patients with post-stroke hemiplegia. Hemiplegia after stroke often results in unilateral motor impairment, balance dysfunction, and decreased proprioception. Although traditional rehabilitation methods can improve certain functions, they are often limited by insufficient central targeting and inadequate activation of deep core muscles, making it difficult to fundamentally repair damaged motor control circuits. FNS, as a non-invasive neuromodulation technique, can precisely target the fastigial nucleus-a critical hub for motor coordination and balance control-thereby modulating neuroplasticity and promoting regional cerebral blood flow to optimize cortical function. SET, on the other hand, utilizes an unstable sling system to efficiently activate deep core muscles (such as the transversus abdominis and multifidus), enhance proprioceptive input, and promote neural reorganization. Based on the concept of "central regulation-peripheral enhancement," this study hypothesizes that the combination of FNS and SET can create a bidirectional intervention pathway, breaking the vicious cycle between central damage and peripheral dysfunction, and achieving a "1+1>2" therapeutic effect. This study employs a randomized, double-blind, sham-controlled design and plans to enroll 54 eligible patients with post-stroke hemiplegia (aged 18-70 years, within 6 months of onset). Participants will be randomly assigned to three groups: Group A (FNS + sham SET), Group B (sham FNS + SET), and Group C (FNS + SET). FNS will be delivered using high-precision electrodes placed over the bilateral mastoid regions, with a stimulation frequency of 180 Hz and an intensity of 2 mA (sham stimulation at 0.1 mA) for 20 minutes per session. SET will include supine and prone bridging exercises for 30 minutes per session, while sham SET involves suspension without active movement. All patients will be assessed before and after the intervention using the Berg Balance Scale, Fugl-Meyer Assessment, three-dimensional gait analysis, trunk control test, and proprioceptive measurement instruments. The sample size was calculated based on previous data for lower extremity Fugl-Meyer scores (effect size f = 0.502), with an estimated 20% dropout rate, resulting in a target of 54 participants. The innovation of this study lies in its first-time combination of FNS-a more targeted neuromodulation approach-with SET-a high-intensity sensorimotor integration training-and the use of sham controls to precisely quantify the individual contributions of each intervention and validate the synergistic effect of central-peripheral co-stimulation. Potential risks will be strictly managed: FNS may cause localized tingling or mild headache, which can be addressed by adjusting or pausing stimulation; SET will be conducted under the supervision of trained therapists with individualized intensity adjustments to prevent muscle soreness or falls. All adverse events will be documented and managed promptly. The findings of this study are expected to provide an effective, non-invasive central-peripheral synergistic rehabilitation strategy for post-stroke hemiplegia and offer evidence-based guidance for clinical practice and future research.

A vizsgálat 3 csoportja

• Group A: FNS + sham SET trainingA vizsgált kezelés

  FNS: High-precision electrodes were used, with the treatment electrodes placed posterior to the mastoid processes on both sides. The stimulation parameters were set at a frequency of 180 Hz and an intensity of 2 mA for 20 minutes. Sham SET training: Patients were only fixed with non-elastic ropes following the SET training method described above, without performing any movements. This was conducted once daily for 30 minutes.

  Kezelés: Cerebellar Fastigial Nucleus Electrical Stimulation

• Group B: sham FNS + SETA vizsgált kezelés

  Sham FNS: Electrodes were placed in the same position (bilaterally posterior to the mastoid processes). The output was set to a subthreshold intensity (0.1 mA, 180 Hz, 20 min) insufficient to alter neuronal excitability but sufficient to maintain a sense of contact. SET: ① Supine bridge: Patient in supine position, ankles fixed with non-elastic ropes. Patient lifts hips to align with trunk. Hold for 10 s, rest for 5 s; 15 repetitions per set, 2 sets. ② Prone bridge: Patient in prone position, ankles suspended with non-elastic ropes to lift feet off the bed. With therapist assistance, patient lifts hips to maintain a horizontal body position. Hold for approximately 10 s, rest for 5 s; 15 repetitions per set, 2 sets. The exercise difficulty was selected and adjusted in a timely manner based on the patient's condition, performance during training, and subjective feedback.

  Kezelés: Sling Exercise Therapy

• Group C: FNS +SETA vizsgált kezelés

  FNS: High-precision electrodes were used, with the treatment electrodes placed posterior to the mastoid processes on both sides. The stimulation parameters were set at a frequency of 180 Hz and an intensity of 2 mA for 20 minutes. SET: ① Supine bridge: Patient in supine position, ankles fixed with non-elastic ropes. Patient lifts hips to align with trunk. Hold for 10 s, rest for 5 s; 15 repetitions per set, 2 sets. ② Prone bridge: Patient in prone position, ankles suspended with non-elastic ropes to lift feet off the bed. With therapist assistance, patient lifts hips to maintain a horizontal body position. Hold for approximately 10 s, rest for 5 s; 15 repetitions per set, 2 sets. The exercise difficulty was selected and adjusted in a timely manner based on the patient's condition, performance during training, and subjective feedback.

  Kezelés: Cerebellar Fastigial Nucleus Electrical Stimulation és Sling Exercise Therapy