No definite consensus has currently been reached regarding the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation in the treatment of post-stroke muscle spasticity.The latest res...No definite consensus has currently been reached regarding the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation in the treatment of post-stroke muscle spasticity.The latest research indicates that when combined with local injections of botulinum toxin type A,it is more effective on post-stroke muscle spasticity than local injections of botulinum toxin type A alone.We designed a prospective,single-center,non-randomized,controlled clinical trial to investigate the safety and effica cy of different frequencies of repetitive transcranial magnetic stimulation combined with local injections of botulinum toxin type A in treating post-stroke lower limb muscle spasticity to determine an optimal therapeutic regimen.This trial will enroll 150 patients with post-stroke muscle spasticity admitted to the Department of Rehabilitation Medicine at the First Affiliated Hos pital of China Medical Unive rsity.All enrolled patients will undergo ro utine rehabilitation training and will be divided into five groups in-30 per group) according to the particular area of cerebral infa rction and treatment methods.G roup A:Patients with massive cerebral infarction will be given local injections of botulinum toxin type A and low-frequency(1 Hz)repetitive transcranial magnetic stimulation on the contralate ral side;G roup B:Patients with non-massive cerebral infarction will be given local injections of botulinum toxin type A and high-frequency(10-20 Hz) re petitive transcranial magnetic stimulation on the affected side;G roup C:Patients with massive/non-massive cerebral infarction will be given local injections of botulinum toxin type A;G roup D:Patients with massive cerebral infarction will be given low-frequency(1 Hz) repetitive transcranial magnetic stimulation on the contralate ral side;and G roup E:Patients with non-massive cerebral infa rction will be given high-frequency(10-20 Hz) repetitive transcranial magnetic stimulation on the affected side.The primary outcome measure of this trial is a modified Ashwo rth scale score from 1 day before treatment to 12 months after treatment.Secondary outcome measures include Fugl-M eyer Assessment of Lower Extremity,Visual Analogue Scale,modified Barthel index,and Berg Balance Scale scores for the same time as specified for primary outcome measures.The safety indicator is the incidence of adverse events at 3-12 months after treatment.We hope to draw a definite conclusion on whether there are diffe rences in the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation combined with botulinum toxin type A injections in the treatment of patients with post-stroke lower limb spasticity under strict grouping and standardized operation,thereby screening out the optimal therapeutic regimen.The study protocol was approved by the Medical Ethics Committee of the First Affiliated Hospital of China Medical University(approval No.[2021] 2021-333-3) on August 19,2021.The trial was registe red with the Chinese Clinical Trial Registry(Registration No.ChiCTR2100052180) on October 21,2021.The protocol version is 1.1.展开更多
目的:分析下肢康复机器人联合悬吊运动训练对脑卒中患者下肢功能和日常生活能力的影响。方法:将2022年1月—2023年7月清远市人民医院收治的脑卒中患者90例作为本次观察对象,采取随机数字表法分成三组:A组(下肢康复机器人)、B组(悬吊运...目的:分析下肢康复机器人联合悬吊运动训练对脑卒中患者下肢功能和日常生活能力的影响。方法:将2022年1月—2023年7月清远市人民医院收治的脑卒中患者90例作为本次观察对象,采取随机数字表法分成三组:A组(下肢康复机器人)、B组(悬吊运动训练)、C组(下肢康复机器人联合悬吊运动训练),每组30例。比较三组训练后下肢Fugl-Meyer评估表(Fugl-Meyer assessment scale,FMA)评分、伯格平衡量表(Berg balance scale,BBS)评分、Holden功能性步行量表(functional amby iation category scale,FAC)评分、6分钟步行试验(6 min walk test,6MWT)及改良Barthel指数(modified Barthel index,MBI)、美国国立卫生研究院卒中量表(national institutes of health stroke scale,NIHSS)评分。结果:训练前,三组下肢FMA、BBS、FAC评分、6MWT、MBI、NIHSS评分比较,差异均无统计学意义(P>0.05);训练后,C组下肢FMA、BBS、FAC、MBI评分均明显更高于A组、B组,6MWT长于A组、B组,NIHSS评分低于A组、B组,差异均有统计学意义(P<0.05);A组、B组各项指标比较,差异均无统计学意义(P>0.05)。结论:在脑卒中后对患者采取下肢康复机器人联合悬吊运动训练,可提高患者下肢运动功能与步行能力,增强患者平衡与下肢运动功能,并改善神经功能,提高生活质量,促进身体康复。展开更多
文摘No definite consensus has currently been reached regarding the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation in the treatment of post-stroke muscle spasticity.The latest research indicates that when combined with local injections of botulinum toxin type A,it is more effective on post-stroke muscle spasticity than local injections of botulinum toxin type A alone.We designed a prospective,single-center,non-randomized,controlled clinical trial to investigate the safety and effica cy of different frequencies of repetitive transcranial magnetic stimulation combined with local injections of botulinum toxin type A in treating post-stroke lower limb muscle spasticity to determine an optimal therapeutic regimen.This trial will enroll 150 patients with post-stroke muscle spasticity admitted to the Department of Rehabilitation Medicine at the First Affiliated Hos pital of China Medical Unive rsity.All enrolled patients will undergo ro utine rehabilitation training and will be divided into five groups in-30 per group) according to the particular area of cerebral infa rction and treatment methods.G roup A:Patients with massive cerebral infarction will be given local injections of botulinum toxin type A and low-frequency(1 Hz)repetitive transcranial magnetic stimulation on the contralate ral side;G roup B:Patients with non-massive cerebral infarction will be given local injections of botulinum toxin type A and high-frequency(10-20 Hz) re petitive transcranial magnetic stimulation on the affected side;G roup C:Patients with massive/non-massive cerebral infarction will be given local injections of botulinum toxin type A;G roup D:Patients with massive cerebral infarction will be given low-frequency(1 Hz) repetitive transcranial magnetic stimulation on the contralate ral side;and G roup E:Patients with non-massive cerebral infa rction will be given high-frequency(10-20 Hz) repetitive transcranial magnetic stimulation on the affected side.The primary outcome measure of this trial is a modified Ashwo rth scale score from 1 day before treatment to 12 months after treatment.Secondary outcome measures include Fugl-M eyer Assessment of Lower Extremity,Visual Analogue Scale,modified Barthel index,and Berg Balance Scale scores for the same time as specified for primary outcome measures.The safety indicator is the incidence of adverse events at 3-12 months after treatment.We hope to draw a definite conclusion on whether there are diffe rences in the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation combined with botulinum toxin type A injections in the treatment of patients with post-stroke lower limb spasticity under strict grouping and standardized operation,thereby screening out the optimal therapeutic regimen.The study protocol was approved by the Medical Ethics Committee of the First Affiliated Hospital of China Medical University(approval No.[2021] 2021-333-3) on August 19,2021.The trial was registe red with the Chinese Clinical Trial Registry(Registration No.ChiCTR2100052180) on October 21,2021.The protocol version is 1.1.
文摘目的:分析下肢康复机器人联合悬吊运动训练对脑卒中患者下肢功能和日常生活能力的影响。方法:将2022年1月—2023年7月清远市人民医院收治的脑卒中患者90例作为本次观察对象,采取随机数字表法分成三组:A组(下肢康复机器人)、B组(悬吊运动训练)、C组(下肢康复机器人联合悬吊运动训练),每组30例。比较三组训练后下肢Fugl-Meyer评估表(Fugl-Meyer assessment scale,FMA)评分、伯格平衡量表(Berg balance scale,BBS)评分、Holden功能性步行量表(functional amby iation category scale,FAC)评分、6分钟步行试验(6 min walk test,6MWT)及改良Barthel指数(modified Barthel index,MBI)、美国国立卫生研究院卒中量表(national institutes of health stroke scale,NIHSS)评分。结果:训练前,三组下肢FMA、BBS、FAC评分、6MWT、MBI、NIHSS评分比较,差异均无统计学意义(P>0.05);训练后,C组下肢FMA、BBS、FAC、MBI评分均明显更高于A组、B组,6MWT长于A组、B组,NIHSS评分低于A组、B组,差异均有统计学意义(P<0.05);A组、B组各项指标比较,差异均无统计学意义(P>0.05)。结论:在脑卒中后对患者采取下肢康复机器人联合悬吊运动训练,可提高患者下肢运动功能与步行能力,增强患者平衡与下肢运动功能,并改善神经功能,提高生活质量,促进身体康复。
