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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05919043
Collaborator
(none)
50
1
4
42
1.2

Study Details

Study Description

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, 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

  • Stimulation-based priming using anodal transcranial direct current stimulation (tDCS).

OR

  • Lower-limb movement-based priming using aerobic exercise on a treadmill or recumbent stepper.

Researchers will compare outcome measures between the different priming sessions.

Condition or Disease Intervention/Treatment Phase
  • Other: Upper limb-based movement priming (UL-priming)
  • Other: Stimulation-based priming (Stim priming)
  • Other: Lower limb-based movement priming (LL-priming)
  • Other: Sham priming
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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.

Active Comparator: Stimulation-based priming (Stim priming)

Participants will receive facilitatory transcranial direct current stimulation (tDCS) through a constant current stimulator.

Other: Stimulation-based priming (Stim priming)
Noninvasive brain stimulation.

Active Comparator: Lower limb-based movement priming (LL-priming)

Participants will perform high-intensity interval-based aerobic exercise on a treadmill or recumbent stepper.

Other: Lower limb-based movement priming (LL-priming)
Aerobic exercise using a treadmill or recumbent stepper.

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.

Outcome Measures

Primary Outcome Measures

  1. Corticomotor excitability using transcranial magnetic stimulation (TMS) [Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.]

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

  2. Spinal H-reflex excitability using peripheral nerve stimulation (PNS) [Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.]

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

  3. Motor control [Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.]

    Motor control will be assessed by making participants track a computer-generated sinusoidal target during an ankle tracking task with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device.

Secondary Outcome Measures

  1. Gait speed [Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.]

    Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-meter walk test (10MWT).

  2. Muscle strength [Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • Dizziness or angina during physical activity

  • Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)

  • Failure to pass the Physical Activity Readiness Questionnaire (PAR-Q)

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

tDCS exclusion criteria

  • Skin hypersensitivity

  • History of contact dermatitis

  • History of allodynia and/or hyperalgesia

  • Any other skin or scalp condition that could be aggravated by tDCS

  • Previous adverse reactions to tDCS

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brain Plasticity Lab Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sangeetha Madhavan, Professor, Physical Therapy, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT05919043
Other Study ID Numbers:
  • 2023-0070
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023