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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05919043
• Other study ID #: 2023-0070
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: University of Illinois at Chicago
• Contact: Sangeetha Madhavan, PT, PhD
• Phone: 312-355-2507
• Email: smadhava[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Upper limb-based movement priming (UL-priming)
Repetitive upper limb movements administered to the beat of a metronome.
• Lower limb-based movement priming (LL-priming)
Repetitive lower limb movements administered to the beat of a metronome.
• Sham priming
Auditory stimulation.

Locations

Country	Name	City	State
United States	Brain Plasticity Lab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.