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

NCT ID: NCT05919043

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-06-25

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. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Upper limb-based movement priming (UL-priming)

Intervention Type: OTHER

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

Lower limb-based movement priming (LL-priming)

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

Group Type: ACTIVE_COMPARATOR

Lower limb-based movement priming (LL-priming)

Intervention Type: OTHER

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

Sham priming

Participants will listen to a 1 Hz metronome for 20 minutes as a form of auditory stimulation during the sham priming session.

Group Type: SHAM_COMPARATOR

Sham priming

Intervention Type: OTHER

Auditory stimulation.

Interventions

Upper limb-based movement priming (UL-priming)

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

Intervention Type: OTHER

Lower limb-based movement priming (LL-priming)

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

Intervention Type: OTHER

Sham priming

Auditory stimulation.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Sangeetha Madhavan

Professor, Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sangeetha Madhavan, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Brain Plasticity Lab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2023-0070

Identifier Type: -

Identifier Source: org_study_id