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临床试验/NCT06538766
NCT06538766招募中不适用

Strength Training for Gait Rehabilitation in Older Adults: Insights From Neuroscience

Egas Moniz - Cooperativa de Ensino Superior, CRL2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
2
主要终点
Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

研究概览

简要总结

The goal of this clinical trial is to investigate the effects of strength training with different focus of attention strategies on plantar flexor force and how this affects gait in apparently healthy older adults. The main questions it aims to answer are:

  • Is there an acute effect of focus of attention on non-linear force variability and the subjacent neurophysiological mechanisms in apparently healthy young and older adults?
  • Is there a training effect of focus of attention on non-linear force variability and does it transfer to non-linear gait variability as well as the respective subjacent neurophysiological mechanisms in apparently healthy older adults?

Researchers will compare two different external focus strategies with an internal focus to see if non-linear variability increases and subjacent neurophysiological mechanisms are more automized with an external focus of attention compared to an internal focus. In the acute study young adults are assessed as the differences between focus conditions are thought to be in the same direction as for older adults but attenuated.

Participants will carry out training and strength assessments of the calf muscles and walking on a treadmill.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Signed informed consent

排除标准

  • Severe cardiovascular or pulmonary disease
  • Oncological disease
  • Lower limb disabilities
  • Neurological disorders
  • Inability to walk unassisted for 12 continuous minutes
  • Cognitive impairment
  • Falls in the prior 12 months
  • Orthopedic concerns, which might limit force production
  • Metal implants
  • Medicine that can trigger side effects with TMS

结局指标

主要结局

Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

The non-linear variability of the temporal structure of the force signal of a 50 seconds isometric task at 50% of the maximum voluntary isometric contraction is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular force output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable force output.

Change from Baseline in Non-linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6)

The non-linear variability of the temporal structure of the gait signal from a 12 minutes gait trial is analyzed using sample entropy (SampEn), which indicates the probability that short sequences of data points are repeated throughout the signal length. Lower SampEn (towards 0) is the consequence of similar distances between repetitions of those sequences, which indicates a more regular gait output. A higher SampEn value (towards infinity) results from large differences of distances between repetitions of sequences, which designates a more irregular, variable gait output.

Change from Baseline in Cortico-Spinal Excitability after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week2, Week4 and Follow-Up (Week6)

The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal excitability single-pulse TMS is applied. For cortico-spinal excitability the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the EMG maximum voluntary contraction.

Change from Baseline in Intra-Cortical Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week2, Week4 and Follow-Up (Week6)

The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical inhibition paired-pulse TMS is applied. For intra-cortical inhibition the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

Change from Baseline in Intra-Cortical Facilitation after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week2, Week4 and Follow-Up (Week6)

The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess intra-cortical facilitation paired-pulse TMS is applied. For intra-cortical facilitation the mean of the MEP amplitude from 10 stimulations is calculated. The values will be presented in % normalized to the cortico-spinal excitability.

Change from Baseline in Cortico-Spinal Inhibition after 2 Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up

时间窗: Baseline, Week2, Week4 and Follow-Up (Week6)

The cortical measures are assessed with transcranial magnetic stimulation (TMS). A stimulator generates motor evoked potentials (MEP) in the active soleus muscle during a low-intensity plantarflexion. To assess cortico-spinal inhibition single-pulse TMS is applied. For cortico-spinal inhibition the mean of electromyographic silent periods from 10 stimulations is calculated. The values are presented in ms.

次要结局

  • Change from Baseline of Hip, Knee, Ankle Range of Motion during Gait after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up(Baseline, Week2, Week4 and Follow-Up (Week6))
  • Change from Baseline of Minimum Toe Clearance during Gait after after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up(Baseline, Week2, Week4 and Follow-Up (Week6))
  • Change from Baseline in Antagonist Co-Contraction Index after 2Weeks, 4 Weeks of Intervention and 2 Weeks Follow-Up(Baseline, Week2, Week4 and Follow-Up (Week6))
  • Change from Baseline in Linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up(Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6))
  • Change from Baseline in Linear Gait Variability after each Week during Intervention and 2 Weeks Follow-Up(Baseline, Week1, Week2, Week3, Week4 and Follow-Up (Week6))

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

研究点 (2)

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