Effect of Dual-Task Exercise in Conjunction with Fluoxetine &Transcranial Direct Current Stimulation (tDCS) on Postural Stability and Gait in StrokePatients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Gait Analysis variables and FMA-LE
研究概览
简要总结
Stroke is the leadingcause of mortality and disability worldwide. Restoration of walking ability andgait rehabilitation are therefore highly relevant for people who are unable towalk independently after stroke.
Aims & Objectives: To determine the effectiveness of dual-taskexercise in conjunction with fluoxetine & transcranial direct currentstimulation (tDCS) on postural stability and gait in stroke patients.
Material & Methods: 224 Patients with first ever stroke were Randomized& Allocated to one of four treatment groups. 12 sessions of bihemispheric tDCS(2mA) with each session lasting for 20 minutes followed by 2 extra sessionsevery other week. 20 mg of Fluoxetine/placebo along with DTT were given for 6 weeks.The gait and clinical variables were used as outcome measures at the time pointbaseline, 1FU (after 6 weeks) & 2 FU (after 12 weeks).
Result: Thestatistical analysis was carried out on average of the three consecutive gaittrials from the Group-A, Group- B, Group-C, and Group-D. A Friedman Test wasused to analyze differences within groups at three different time points forgait and clinical variables. A Krushkal Wallis Test was used to measure meanrank differences between gait and clinical variables of four groups at threedifferent time points.
There was no statisticallysignificant difference between the groups at the time point baseline in the allgait and clinical variables. There were statistically significantdifference between the groups at thetime point 1 FU in the gait variables such as Cadence, Gait Time, GaitDistance, Gait Velocity, Step Time, Step Length, Stride Time, Stride Length, StancePhase Time and double support time respectively (p = 0.001, p = 0.001, p = 0.001,p = 0.001, p = 0.002, p = 0.001, p = 0.001, p = 0.001 p = 0.002, and p = 0.005 respectively)and FMA scores (p = 0.001) . There were statistically significant differencesbetween the groups at the time point 2 FU in the gait variables such asCadence, Gait Time, Gait Distance, Gait Velocity, Step Time, Step Length,Stride Time, Stride Length, Stance Phase Time, and Double Support Phase Timerespectively (p = 0.002, p = 0.001, p = 0.001, p = 0.001, p = 0.004, p = 0.001, p = 0.001, p = 0.001, p = 0.007, andp = 0.001 respectively ) and FMA scores ((p = 0.001). No statisticallysignificant difference between the group in respect to Step width and SwingPhase Time.
Conclusion:
It was found that the combination therapy with Dual Task Training (DTT), Fluoxetine and transcranialdirect current stimulation (tDCS) is more efficacious than individual therapywith Fluoxetine or tDCS or sham and Placebo alone.
Key Words:
Stroke Rehabilitation,Fluoxetine, Transcranial Direct Current Stimulation, Dual Task Exercise, MotorRecovery, Cortical Excitability, Gait
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •First-time ischemic or hemorrhagic stroke as diagnosed by CT/MRI
- •Ischemic or hemorrhagic stroke between 1 to 6 months from the index event that has caused hemiparesis, as examined and/or confirmed by medical records.
- •Able to stand with support
- •Both gender; age ≥ 18 years and ≤ 75 years
- •Conscious and comprehensible
- •Subjects need to be able to provide informed consent.
排除标准
- •Stroke patients < 18 years and > 75 years
- •Patient with any disability other than stroke that would preclude gait training,
- •Taking antidepressant drugs two weeks before inclusion
- •Patients taking any other selective serotonin reuptake inhibitors (SSRI) at the time of enrollment or two weeks before inclusion.
- •Patients taking any other medication likely to have adverse interaction with SSRIs Flaccid hemiplegia
- •Taking neuroleptic drugs or benzodiazepines 2 weeks before inclusion
- •Other major diseases with life expectancy ≤ 3 months.
- •Any uncontrolled health condition for which exercise is contraindicated,
- •Any neurologic or orthopedic diseases that might interfere with the study,
- •Metallic implant within the brain
- •Cardiac pace maker
- •Cognitive impairments 16.
结局指标
主要结局
Gait Analysis variables and FMA-LE
时间窗: At Baseline, After 6 Weeks, and After 12 Weeks
次要结局
- 1.NIHSS(2.Modified Rankin scale (mRS))