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

NCT05919043 | Completed DMC

• 1 other identifier: 2023-0070
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.What are the time effects of UL-priming on neuroplasticity and motor behavior in individuals with stroke?

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

Upper limb-based movement priming (UL-priming)

EXPERIMENTAL

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)

Lower limb-based movement priming (LL-priming)

ACTIVE COMPARATOR

Participants will perform rhythmic, symmetric, bilateral plantarflexion and dorsiflexion movements.

Other: Lower limb-based movement priming (LL-priming)

Sham priming

SHAM COMPARATOR

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

Interventions

Upper limb-based movement priming (UL-priming) OTHER

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

Upper limb-based movement priming (UL-priming)

Lower limb-based movement priming (LL-priming) OTHER

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

Lower limb-based movement priming (LL-priming)

Sham priming OTHER

Auditory stimulation.

Sham priming

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Brain Plasticity Lab

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Sangeetha Madhavan, PT, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physical Therapy

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: June 26, 2023
• Study Start: July 1, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: July 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)