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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Upper limb-based movement priming (UL-priming); Other: Sham priming; Other: Lower limb-based movement priming (LL-priming)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Brain Plasticity Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upper limb-based movement priming (UL-priming); The upper limb priming task will include rhythmic, bilateral priming involving the movement of at least one major joint in the upper limbs (shoulder, elbow, wrist).	Other: Upper limb-based movement priming (UL-priming); Repetitive upper limb movements administered to the beat of a metronome.
Sham Comparator: Sham priming; Participants will listen to a 1 Hz metronome for 20 minutes as a form of auditory stimulation during the sham priming session.	Other: Sham priming; Auditory stimulation.
Active Comparator: Lower limb-based movement priming (LL-priming); Participants will perform rhythmic, symmetric, bilateral plantarflexion and dorsiflexion movements.	Other: Lower limb-based movement priming (LL-priming); Repetitive lower limb movements administered to the beat of a metronome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corticomotor excitability using transcranial magnetic stimulation (TMS)	Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior and soleus muscles.	Change from baseline to immediately after priming and to 24 hours after priming.
Spinal H-reflex excitability using peripheral nerve stimulation (PNS)	Peripheral nerve stimulation (PNS) will be used to assess the H reflexes excitability from the soleus muscles.	Change from baseline to immediately after priming and to 24 hours after priming.
Muscle Strength	An estimate of maximum ankle muscle force will be obtained for three trials of dorsiflexion and plantarflexion contractions using a force transducer and EMG.	Change from baseline to immediately after priming and to 24 hours after priming.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-meter walk test (10MWT).	Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.
Muscle strength	An estimate of maximum ankle muscle force will be obtained for three trials of dorsiflexion and plantarflexion contractions using a force transducer.	Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Sangeetha Madhavan, PT, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2023-0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No