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Completed

NCT Number: NCT05919043

Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke

The goal of this clinical trial is to to determine the effect of movement-based priming using the upper limbs on lower limb neuroplasticity and behaviors in chronic stroke.

The main questions we aim to answer are:

1. What are the acute effect of UL-priming on lower limb neuroplasticity and motor behaviors in persons with stroke compared to other priming modalities? 2. What are the time effects of UL-priming on neuroplasticity and motor behavior in individuals with stroke?

In this cross over study, participants will be involved in three priming sessions involving

- UL-priming using rhythmic, symmetric, bilateral priming involving the movement of at least one major joint in the upper limbs.

AND

- Sham priming using auditory stimulation (1 Hz metronome).

AND

- Lower-limb movement-based priming using rhythmic, symmetric, dorsiflexion and plantarflexion movements.

Researchers will compare outcome measures between the different priming sessions.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Plasticity Lab

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single, monohemispheric stroke
  • Chronic stroke (> 6 months prior)
  • Residual hemiparetic gait deficits (e.g., abnormal gait pattern)
  • Minimum score of stage 2 on the Chedoke Arm Impairment Scale which includes stage 2, task 3 (facilitated elbow flexion) as one of the stage 2 tasks.

Exclusion criteria

  • Use of anti-spasticity medications
  • Existence of other neurological disorders
  • Have brainstem or cerebellar lesions.
  • Score of ≥2 on the Modified Ashworth Scale.
  • MMSE score of <21, to ensure they will follow instructions.
  • Non-English-speaking individuals
  • Bone, joint or soft tissue injury
  • Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
  • No Motor evoked potentials (MEPs) during TMS

TMS exclusion criteria

  • Previous adverse reaction to TMS
  • Skull abnormalities or fractures
  • Concussion within the prior 6 months
  • Unexplained, recurring headaches
  • Implanted cardiac pacemaker
  • Metal implants in the head or face
  • History of seizures or epilepsy
  • Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
  • Current pregnancy

Treatment and study plan

Upper limb-based movement priming (UL-priming)

Other

Repetitive upper limb movements administered to the beat of a metronome.

Lower limb-based movement priming (LL-priming)

Other

Repetitive lower limb movements administered to the beat of a metronome.

Sham priming

Other

Auditory stimulation.

Primary outcomes

  1. Corticomotor excitability using transcranial magnetic stimulation (TMS)

    Time frame: Change from baseline to immediately after priming and to 24 hours after priming.

    Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior and soleus muscles.

  2. Spinal H-reflex excitability using peripheral nerve stimulation (PNS)

    Time frame: Change from baseline to immediately after priming and to 24 hours after priming.

    Peripheral nerve stimulation (PNS) will be used to assess the H reflexes excitability from the soleus muscles.

  3. Muscle Strength

    Time frame: Change from baseline to immediately after priming and to 24 hours after priming.

    An estimate of maximum ankle muscle force will be obtained for three trials of dorsiflexion and plantarflexion contractions using a force transducer and EMG.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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