Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol
Abstract Background Balance dysfunction affects 70% of stroke patients. Emerging neurophysiological approaches, such as virtual reality therapy (VRT) and repetitive transcranial magnetic stimulation (rTMS), have been proven by clinical studies that the balance function of stroke patients can be impr...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-10-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-024-08519-6 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850202151178993664 |
|---|---|
| author | Yuanyuan Liu Ruizhu Lin Xinbao Tian Junyi Wang Ying Tao Ning Zhu |
| author_facet | Yuanyuan Liu Ruizhu Lin Xinbao Tian Junyi Wang Ying Tao Ning Zhu |
| author_sort | Yuanyuan Liu |
| collection | DOAJ |
| description | Abstract Background Balance dysfunction affects 70% of stroke patients. Emerging neurophysiological approaches, such as virtual reality therapy (VRT) and repetitive transcranial magnetic stimulation (rTMS), have been proven by clinical studies that the balance function of stroke patients can be improved when applied alone, but there are relatively few studies on the combined treatment of balance dysfunction after stroke. This study aimed to evaluate the impact of a 4-week intensive intervention combining VRT and rTMS on both balance function and brain plasticity among stroke patients. Methods This single-blind, randomized controlled trial was conducted at the Rehabilitation Medical Center of the Rehabilitation General Hospital of Ningxia Medical University. A cohort of 136 stroke patients, with durations of 2 to 24 weeks post-stroke, were enrolled in the study. Participants were randomly allocated in a 1:1:1:1 ratio to four groups: the VR group (n = 34), the rTMS group (n = 34), the combined treatment group receiving both VR and rTMS (n = 34), and the control group undergoing traditional balance training (n = 34). All patients underwent a standardized inpatient rehabilitation program over 4 weeks. The VR group received daily 30-min sessions of VR therapy for 20 days. The rTMS group underwent daily sessions of rTMS stimulation for 20 min, targeting the motor imagery region in the affected hemisphere. The combination group received VR therapy after completing their rTMS treatment. The control group received conventional balance training, with each session lasting 30 min. Additionally, all patients received an extra 60 min of standard rehabilitation therapy twice daily. Assessments were conducted at baseline, 2 weeks, and 4 weeks post-treatment, using the Berg Balance Scale (BBS) as the primary measure, and secondary measures including the Timed Up-and-Go Test (TUGT), Fugl-Meyer Assessment-Lower Extremity (FMA-LE), and 6-m walking test (6MWT), as well as assessments for brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VGEF), tyrosine receptor kinase (TrκB), motor-evoked potential latency (PL), central motor conduction time (CMCT), and amplitude. Discussion The widespread application of VR technology and rTMS in clinical settings is well-established. However, the potential synergistic effects of combining these modalities on balance function and neuroplasticity in stroke patients remain uncertain. Our hypothesis suggests that the integration of VR with rTMS may result in more pronounced improvements in both balance function and neuroplasticity among stroke patients, surpassing the outcomes achievable with VR alone, rTMS alone, or traditional therapy. The possible mechanism is that VR-based training combined with rTMS plays a superimposed effect, promoting better repair of damaged neurons and ultimately improving balance function in stroke patients. The positive results anticipated from this trial could provide objective evidence advocating for the concurrent use of VR and rTMS in clinical interventions. Trial registration The study protocol underwent review and approval by the Medical Research Ethics Committee of the General Hospital of Ningxia Medical University on January 26, 2024 (No. KYLL-2024–0162). Subsequently, it was registered in the Chinese Clinical Trial Registry on March 11, 2024 (registration number: ChiCTR2400081775). Currently, the study is still ongoing. |
| format | Article |
| id | doaj-art-671eea715f9f4e9f88efa37fba9d15bd |
| institution | OA Journals |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-671eea715f9f4e9f88efa37fba9d15bd2025-08-20T02:11:50ZengBMCTrials1745-62152024-10-0125111210.1186/s13063-024-08519-6Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocolYuanyuan Liu0Ruizhu Lin1Xinbao Tian2Junyi Wang3Ying Tao4Ning Zhu5General Hospital of Ningxia Medical UniversityGeneral Hospital of Ningxia Medical UniversityGeneral Hospital of Ningxia Medical UniversityThe Beijing NuoYiteng Technology Co. LTDGeneral Hospital of Ningxia Medical UniversityGeneral Hospital of Ningxia Medical UniversityAbstract Background Balance dysfunction affects 70% of stroke patients. Emerging neurophysiological approaches, such as virtual reality therapy (VRT) and repetitive transcranial magnetic stimulation (rTMS), have been proven by clinical studies that the balance function of stroke patients can be improved when applied alone, but there are relatively few studies on the combined treatment of balance dysfunction after stroke. This study aimed to evaluate the impact of a 4-week intensive intervention combining VRT and rTMS on both balance function and brain plasticity among stroke patients. Methods This single-blind, randomized controlled trial was conducted at the Rehabilitation Medical Center of the Rehabilitation General Hospital of Ningxia Medical University. A cohort of 136 stroke patients, with durations of 2 to 24 weeks post-stroke, were enrolled in the study. Participants were randomly allocated in a 1:1:1:1 ratio to four groups: the VR group (n = 34), the rTMS group (n = 34), the combined treatment group receiving both VR and rTMS (n = 34), and the control group undergoing traditional balance training (n = 34). All patients underwent a standardized inpatient rehabilitation program over 4 weeks. The VR group received daily 30-min sessions of VR therapy for 20 days. The rTMS group underwent daily sessions of rTMS stimulation for 20 min, targeting the motor imagery region in the affected hemisphere. The combination group received VR therapy after completing their rTMS treatment. The control group received conventional balance training, with each session lasting 30 min. Additionally, all patients received an extra 60 min of standard rehabilitation therapy twice daily. Assessments were conducted at baseline, 2 weeks, and 4 weeks post-treatment, using the Berg Balance Scale (BBS) as the primary measure, and secondary measures including the Timed Up-and-Go Test (TUGT), Fugl-Meyer Assessment-Lower Extremity (FMA-LE), and 6-m walking test (6MWT), as well as assessments for brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VGEF), tyrosine receptor kinase (TrκB), motor-evoked potential latency (PL), central motor conduction time (CMCT), and amplitude. Discussion The widespread application of VR technology and rTMS in clinical settings is well-established. However, the potential synergistic effects of combining these modalities on balance function and neuroplasticity in stroke patients remain uncertain. Our hypothesis suggests that the integration of VR with rTMS may result in more pronounced improvements in both balance function and neuroplasticity among stroke patients, surpassing the outcomes achievable with VR alone, rTMS alone, or traditional therapy. The possible mechanism is that VR-based training combined with rTMS plays a superimposed effect, promoting better repair of damaged neurons and ultimately improving balance function in stroke patients. The positive results anticipated from this trial could provide objective evidence advocating for the concurrent use of VR and rTMS in clinical interventions. Trial registration The study protocol underwent review and approval by the Medical Research Ethics Committee of the General Hospital of Ningxia Medical University on January 26, 2024 (No. KYLL-2024–0162). Subsequently, it was registered in the Chinese Clinical Trial Registry on March 11, 2024 (registration number: ChiCTR2400081775). Currently, the study is still ongoing.https://doi.org/10.1186/s13063-024-08519-6StrokeRepetitive transcranial magnetic stimulation (rTMS)Virtual reality trainingMotor-evoked potentials (MEPs)Serum biomarkers |
| spellingShingle | Yuanyuan Liu Ruizhu Lin Xinbao Tian Junyi Wang Ying Tao Ning Zhu Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol Trials Stroke Repetitive transcranial magnetic stimulation (rTMS) Virtual reality training Motor-evoked potentials (MEPs) Serum biomarkers |
| title | Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol |
| title_full | Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol |
| title_fullStr | Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol |
| title_full_unstemmed | Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol |
| title_short | Effects of VR task-oriented training combined with rTMS on balance function and brain plasticity in stroke patients: a randomized controlled trial study protocol |
| title_sort | effects of vr task oriented training combined with rtms on balance function and brain plasticity in stroke patients a randomized controlled trial study protocol |
| topic | Stroke Repetitive transcranial magnetic stimulation (rTMS) Virtual reality training Motor-evoked potentials (MEPs) Serum biomarkers |
| url | https://doi.org/10.1186/s13063-024-08519-6 |
| work_keys_str_mv | AT yuanyuanliu effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol AT ruizhulin effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol AT xinbaotian effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol AT junyiwang effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol AT yingtao effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol AT ningzhu effectsofvrtaskorientedtrainingcombinedwithrtmsonbalancefunctionandbrainplasticityinstrokepatientsarandomizedcontrolledtrialstudyprotocol |