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

Effects of Cerebellar Fastigial Nucleus Electrical Stimulation Combined With Sling Exercise Therapy on Motor Function in Hemiplegic Patients After Stroke

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Device: Sling Exercise Therapy

Detailed Description

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 recovery in patients with post-stroke hemiplegia, addressing a critical gap in current neurorehabilitation strategies where conventional physical therapy often demonstrates limited efficacy due to insufficient central neuromodulation and inadequate activation of deep core musculature, thereby failing to fundamentally repair damaged motor control circuits and optimize sensorimotor integration. Hemiplegia following cerebrovascular accident typically presents with unilateral motor impairment, profound balance dysfunction, decreased proprioceptive acuity, and impaired coordination, which collectively compromise activities of daily living, increase fall risk, and diminish quality of life, while traditional rehabilitation approaches, though fundamental for preventing secondary complications such as joint contractures and muscle atrophy, exhibit inherent limitations including indirect and non-specific modulation of cortical and subcortical motor regions, inefficient recruitment of deep spinal stabilizers like transversus abdominis and multifidus, suboptimal proprioceptive feedback generation, and markedly reduced effectiveness during the chronic phase when neuroplastic potential naturally declines. Fastigial Nucleus Stimulation, as a non-invasive neuromodulation technique, offers distinct mechanistic advantages over broader stimulation modalities such as transcranial magnetic stimulation by precisely targeting the fastigial nucleus within the deep cerebellum, which serves as a critical hub within the cerebello-thalamo-cortical pathway governing postural control, axial motor regulation, balance coordination, and sensorimotor integration, thereby activating this circuit to enhance cortical excitability, promote activity-dependent neuroplasticity, increase regional cerebral blood flow in motor-related areas, and create a neurophysiologically favorable environment for functional reorganization, with clinical studies demonstrating significant improvements in limb motor function following FNS intervention alongside advantages of non-invasiveness, high safety profile, and seamless integration with concurrent physical therapy. Sling Exercise Training represents a paradigm shift from conventional exercise methodologies by utilizing an unstable suspension system to generate high-intensity neuromuscular challenge, which uniquely facilitates selective activation of deep core stabilizers that remain largely inaccessible through traditional mat-based exercises, provides extraordinarily rich proprioceptive afferent input through continuous postural adjustments, promotes closed-chain kinetic patterns essential for functional activities, and drives use-dependent cortical reorganization through enhanced sensorimotor coupling, with research confirming superior efficiency of SET in activating core musculature and improving sensorimotor control compared to conventional peripheral training methods, and established correlations between improved core stability and enhanced activities of daily living, limb function, and quality of life. The pathophysiological basis for combining these interventions stems from understanding post-stroke motor dysfunction as a self-perpetuating vicious cycle wherein central nervous system damage disrupts motor command generation and sensorimotor integration, leading to peripheral maladaptation including muscle atrophy, weakness, and degraded proprioceptive acuity, which in turn provides degraded feedback to the central nervous system, further impairing motor control; therefore, a combined central-peripheral approach targeting both ends of this cycle simultaneously may produce synergistic effects exceeding the sum of individual interventions, with FNS providing targeted central drive by priming the cerebello-thalamo-cortical pathway and enhancing cortical readiness to process sensory information and generate effective motor output, while SET generates high-fidelity proprioceptive feedback from activated musculature that serves as precise afferent input for the primed central nervous system to update internal motor models and strengthen synaptic connections through Hebbian plasticity mechanisms, thus establishing a bidirectional intervention loop potentially capable of producing superior functional outcomes. This study employs a rigorous prospective, single-center, randomized, double-blind, sham-controlled parallel-arm design conducted in the Department of Rehabilitation Medicine, with protocol approved by the Institutional Review Board, registration in a public clinical trials registry, and full adherence to Declaration of Helsinki principles and CONSORT reporting guidelines. A total of 54 participants with post-stroke hemiplegia will be recruited from the inpatient population, meeting specific inclusion criteria including confirmed stroke diagnosis by CT or MRI, age between 18 and 70 years inclusive, time since onset within six months, presence of lower limb hemiplegia with sufficient cognitive capacity to follow instructions, medical stability, and provision of written informed consent, while exclusion criteria encompass severe organ dysfunction, significant musculoskeletal conditions precluding exercise participation, psychiatric history or severe cognitive impairment, pre-existing vestibular dysfunction, medical instability requiring mechanical ventilation, contraindications to FNS including epilepsy history or intracranial metal implants, and pregnancy. Randomization will be performed by an independent research assistant using computer-generated random number tables with 1:1:1 allocation to three groups, allocation concealment maintained through sequentially numbered opaque sealed envelopes opened only after baseline assessment confirmation of eligibility, and rigorous double-blinding implemented wherein participants remain unaware of group assignment through perceptually indistinguishable sham interventions including sham FNS delivered at 0.1 mA intensity producing sub-threshold but perceptible sensation and sham SET involving passive suspension without active exercise, assessors remain blinded to group allocation throughout all pre-intervention and post-intervention evaluations, and data analysts receive coded datasets without group identifiers for blinded statistical analysis. Group allocation assigns participants to Group A receiving active FNS combined with sham SET, Group B receiving sham FNS combined with active SET, and Group C receiving both active FNS and active SET, with all participants continuing standard medical care and basic physical therapy as prescribed by their primary physicians to maintain ethical equipoise, and study interventions administered once daily consecutively to maximize synergistic interaction potential over a four-week intervention period. FNS intervention utilizes high-precision programmable stimulation device with self-adhesive high-conductivity electrodes placed bilaterally over mastoid process regions, active stimulation parameters set at 180 Hz frequency, 2 mA constant current intensity with appropriate pulse width, delivered for 20 minutes per session, while sham FNS maintains identical frequency and pulse width but reduces intensity to 0.1 mA below neuronal excitation threshold yet sufficient to produce comparable skin sensation, with the same device used for both active and sham conditions ensuring identical appearance and start-up sounds to maintain blinding integrity. SET intervention employs commercial sling exercise training system with ceiling-mounted frame, non-elastic slings, ropes, and hooks, all sessions supervised by qualified physical therapists with specialized SET training, active SET protocol comprising supine bridging exercise with slings placed under both ankles requiring participants to lift hips forming straight line from shoulders to knees held for 10 seconds followed by 5 seconds rest performed for 15 repetitions per set across two sets, and prone bridging exercise with slings under both ankles lifting feet off plinth requiring participants with therapist assistance as needed to lift hips and trunk supporting body weight on forearms and slings maintaining straight body position held for 10 seconds followed by 5 seconds rest for 15 repetitions across two sets, with exercise progression implemented through suspension point addition, elastic cord oscillation, or base of support reduction based on therapist assessment of performance and fatigue, total session duration 30 minutes including rest periods, while sham SET involves identical positioning in slings but participants instructed to relax and remain passive without performing voluntary muscle contractions throughout the 30-minute session duration. Outcome assessments are conducted at baseline within one week before intervention initiation and post-intervention within one week following four-week intervention completion by the same blinded assessor to ensure measurement consistency, with primary outcome measure being Fugl-Meyer Assessment Lower Extremity, a stroke-specific performance-based impairment index with excellent reliability and validity for assessing lower limb motor function, coordination, and sensation with maximum score of 34 and higher scores indicating better function. Secondary outcome measures include Berg Balance Scale, a 14-item gold-standard clinical balance assessment tool with scores ranging from 0 to 56 and higher scores indicating better balance; three-dimensional gait analysis using motion capture systems and force platforms to extract spatiotemporal parameters including gait speed, stride length, cadence, step width, and symmetry, as well as kinematic parameters including hip, knee, and ankle joint angles throughout gait cycle; Trunk Control Test assessing selective motor control of trunk through four items including rolling to weak side, rolling to strong side, sitting up from lying down, and maintaining sitting balance, with total score ranging from 0 to 100 and higher scores indicating better trunk control; and proprioception measurement using isokinetic dynamometer or electrogoniometer through passive or active joint repositioning tasks typically at knee or ankle joints of affected limb, recording absolute angular error between target angle and reproduced angle as measure of proprioceptive acuity with smaller errors indicating better proprioception. Sample size calculation was performed using G*Power 3.1 software based on preliminary analysis of data from stroke patients treated in the rehabilitation center over the past year, yielding an effect size of 0.502 for change in Fugl-Meyer Assessment Lower Extremity scores between groups, which according to Cohen's conventions represents a medium-to-large effect size, and with parameters set at α err probability of 0.05, power of 0.80, and three groups, the software calculated a required sample size of 42 participants, which after adjustment for anticipated 20% dropout rate due to potential medical instability, non-compliance, or loss to follow-up, and rounding up to allow equal group allocation, resulted in final target sample size of 54 participants with 18 participants per group. Statistical analysis will be performed using SPSS software with two-tailed p-value less than 0.05 considered statistically significant, conducted on intention-to-treat basis meaning all participants analyzed in originally randomized groups regardless of protocol adherence, with descriptive statistics summarizing baseline demographic and clinical characteristics, continuous data tested for normality using Shapiro-Wilk test and presented as mean plus standard deviation if normally distributed or median with interquartile range if non-normally distributed, categorical data presented as frequencies and percentages, baseline comparability assessed using one-way ANOVA or Kruskal-Wallis test for continuous variables and chi-square tests for categorical variables, within-group comparisons analyzed using paired-sample t-test for normally distributed data or Wilcoxon signed-rank test for non-normally distributed data, and primary between-group comparisons analyzing post-intervention outcome measures among three groups while controlling for baseline scores using one-way Analysis of Covariance for normally distributed data with baseline score as covariate followed by post-hoc pairwise comparisons with Bonferroni correction if significant main effect found, or using Kruskal-Wallis test comparing change scores across groups followed by post-hoc Mann-Whitney U tests with Bonferroni-adjusted alpha level for non-normally distributed data that cannot be transformed. The innovation of this study lies in its first-time rigorous investigation of combining FNS as a precisely targeted neuromodulation technique with SET as a high-intensity sensorimotor integration training modality, utilizing sham-controlled design to precisely quantify the independent contributions of each intervention and statistically validate the synergistic effect of central-peripheral co-stimulation, with the primary test of synergy being pairwise comparison demonstrating that improvement in the combined group significantly exceeds improvement in both the FNS-alone group and SET-alone groups, thereby providing robust evidence for true synergistic interaction rather than merely additive effects. Risk management protocols prioritize participant safety through comprehensive pre-screening excluding individuals with contraindications, FNS-related risks including local skin sensation, mild headache, or dizziness managed through strict intensity limitation to 2 mA, continuous monitoring during sessions, and adverse event protocols involving stimulation pausing for mild discomfort with possible resumption at reduced intensity after symptom resolution, and permanent discontinuation with appropriate medical follow-up for persistent or severe symptoms, while SET-related risks including muscle soreness, fatigue, muscle strain, or rare fall or injury managed through continuous qualified therapist supervision, daily equipment safety inspections, strictly individualized exercise progression based on patient status and feedback, and adverse event protocols involving exercise modification or session termination for significant soreness or fatigue, and immediate first aid with physician assessment and study withdrawal for falls or injuries. All study personnel are trained in basic life support, first-aid kits are readily available in treatment areas, and participants are informed of their right to withdraw from the study at any time without affecting future medical care. The findings of this comprehensive investigation are expected to provide high-quality evidence establishing an effective, non-invasive central-peripheral synergistic rehabilitation strategy for post-stroke hemiplegia, potentially establishing new evidence-based treatment protocols for improving motor recovery, with results interpreted in context of study hypotheses and existing literature, discussing potential neurophysiological mechanisms if synergy is found including how FNS may prime the central nervous system to better utilize enhanced proprioceptive input from SET, or exploring potential reasons if synergy is not found including suboptimal stimulation parameters, insufficient treatment duration, or patient selection factors, while acknowledging methodological strengths including randomized double-blind sham-controlled design and validated outcome measures, and limitations including single-center design, relatively short intervention period, and lack of long-term follow-up, with recommendations for future research including multi-center trials with larger sample sizes, longer intervention and follow-up periods, investigations into optimal dosing parameters, and use of neuroimaging or neurophysiological techniques such as transcranial magnetic stimulation or functional magnetic resonance imaging to directly probe underlying mechanisms of action, thereby contributing significantly to the development of more effective mechanism-based rehabilitation strategies and providing a robust evidence base for clinical decision-making in post-stroke care.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xue Jiang; Phone Number: +8618940254064; Email: jiangxueruby@163.com
• Study Contact Backup: Name: Mengyuan Yu; Phone Number: +8619537240701; Email: Decads0110@qq.com

Study Locations

• China
  • Shenyang, China
    • Rehabilitation Center of Shengjing Hospital, China Medical University, shenyang, Liaoning 110000
    • Contact: Xue Jiang; Phone Number: +86 189 4025 4064; Email: jiangxueruby@163.com
    • Contact: Mengyuan Yu; Phone Number: +8619537240701; Email: Decads0110@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Met the diagnostic criteria for cerebrovascular disease in Western medicine;
2. Were conscious, with stable vital signs and emotional state;
3. Were male or female, aged 18 to 70 years, with disease onset within the previous 6 months;
4. Had no significant cognitive or auditory comprehension impairments, were able to understand and execute relevant instructions, and could cooperate with the completion of relevant rehabilitation assessments;
5. Were informed about the study and had signed an informed consent form.

Exclusion Criteria:

1. Presence of severe organ dysfunction involving the cardiovascular, pulmonary, liver, or renal systems;
2. Severe joint diseases, incompletely healed fractures, or severe osteoporosis;
3. History of psychiatric illness or severe cognitive, visual, or auditory comprehension impairments that would prevent cooperation with instructions;
4. Concurrent vestibular dysfunction;
5. Unstable vital signs;
6. Patients requiring mechanical ventilation;
7. Contraindications to FNS, such as a history of epilepsy or the presence of intracranial metal foreign bodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: FNS + sham SET training; 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.	Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Participants received group-specific interventions 5 days/week for 4 weeks.
Experimental: Group B: sham FNS + SET; 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.	Device: Sling Exercise Therapy; Participants received group-specific interventions 5 days/week for 4 weeks.
Experimental: Group C: FNS +SET; 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.	Device: Cerebellar Fastigial Nucleus Electrical Stimulation; Participants received group-specific interventions 5 days/week for 4 weeks.; Device: Sling Exercise Therapy; Participants received group-specific interventions 5 days/week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional near-infrared spectroscopy	Near-infrared Brain Functional Imaging：The testing areas cover the bilateral prefrontal lobes, motor areas, occipital lobes, and other brain regions. Within 1 week before treatment initiation, a physician will collect resting-state and task-state fNIRS data from enrolled patients.Resting-State Data Collection：The patient is fitted with an fNIRS measurement headcap. In a quiet, comfortable environment, they are instructed to sit, relax, keep eyes closed (without falling asleep), and data are collected for 5 minutes.Task-State Data Collection：A walking paradigm is set up. The test includes a 10-second preparatory phase where the patient stands at rest, followed by the task phase:Upon the command "Please start walking," the subject alternates stepping for 30 seconds.At the command "Stop," they cease walking and stand in place to rest for 30 seconds. This "walk-rest" cycle is repeated 4 times.Identical data collection will be completed within 1 week after treatment concludes.	Baseline, 4-weeks treatment
Three-Dimensional Gait	Gait spatiotemporal parameters - Lower limb joint angles - Lower limb joint moments - Ground reaction forces etc.	Baseline, 4-weeks treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment	The Fugl-Meyer Assessment (FMA) is used to evaluate the lower limb motor function and coordination of research subjects. Modified from the Brunnstrom evaluation method, this scale is divided into two parts: upper limb and lower limb motor function assessment, with only the lower limb subscale (FMA-LE) applied in this study. The FMA-LE consists of 17 items, each graded into three levels (0 points = unable to perform; 1 point = partially performed; 2 points = fully performed), with a total score ranging from 0 to 34. A higher score indicates better lower limb motor function.	Baseline, 4-weeks treatment

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Chair: Xue Jiang, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Motor Function; Cerebellar Fastigial Nucleus Electrical Stimulation; Sling Exercise Therapy; Three-Dimensional Gait
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2025PS1878K(X1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be made available under reasonable request after publication. Data will include de-identified participant data and the data dictionary. Requests can be submitted to the corresponding author. Request will be analyzed and ethical and legal implications of data sharing will be considered. Data will be shared after consent of study participants
• IPD Sharing Time Frame: After publication under reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No