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Clinical Trials/NCT06538766
NCT06538766
Recruiting
N/A

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

Egas Moniz - Cooperativa de Ensino Superior, CRL1 site in 1 country45 target enrollmentApril 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Aging
Sponsor
Egas Moniz - Cooperativa de Ensino Superior, CRL
Enrollment
45
Locations
1
Primary Endpoint
Change from Baseline in Non-linear Force Variability after each Week during Intervention and 2 Weeks Follow-Up
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
April 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Egas Moniz - Cooperativa de Ensino Superior, CRL
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \- Signed informed consent

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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