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

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Upper limb-based movement priming (UL-priming)
Stimulation-based priming (Stim priming)
Lower limb-based movement priming (LL-priming)
Sham priming
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brain Plasticity Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Upper limb-based movement priming (UL-priming)

Stimulation-based priming (Stim priming)

Lower limb-based movement priming (LL-priming)

Sham priming

Arm Description

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).

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

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

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

Outcomes

Primary Outcome Measures

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 muscles.
Spinal H-reflex excitability using peripheral nerve stimulation (PNS)
Peripheral nerve stimulation (PNS) will be used to assess the H reflexes excitability from the soles muscles.
Motor control
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

Gait speed
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-meter walk test (10MWT).
Muscle strength
An estimate of maximum ankle muscle force will be obtained for three trials of dorsiflexion and plantarflexion contractions using a force transducer.

Full Information

First Posted
May 1, 2023
Last Updated
June 15, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05919043
Brief Title
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
Official Title
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: What are the acute effect of UL-priming on lower limb neuroplasticity and motor behaviors in persons with stroke compared to other priming modalities? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upper limb-based movement priming (UL-priming)
Arm Type
Experimental
Arm Description
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).
Arm Title
Stimulation-based priming (Stim priming)
Arm Type
Active Comparator
Arm Description
Participants will receive facilitatory transcranial direct current stimulation (tDCS) through a constant current stimulator.
Arm Title
Lower limb-based movement priming (LL-priming)
Arm Type
Active Comparator
Arm Description
Participants will perform high-intensity interval-based aerobic exercise on a treadmill or recumbent stepper.
Arm Title
Sham priming
Arm Type
Sham Comparator
Arm Description
Participants will listen to a 1 Hz metronome for 20 minutes as a form of auditory stimulation during the sham priming session.
Intervention Type
Other
Intervention Name(s)
Upper limb-based movement priming (UL-priming)
Intervention Description
Repetitive upper limb movements administered to the beat of a metronome.
Intervention Type
Other
Intervention Name(s)
Stimulation-based priming (Stim priming)
Intervention Description
Noninvasive brain stimulation.
Intervention Type
Other
Intervention Name(s)
Lower limb-based movement priming (LL-priming)
Intervention Description
Aerobic exercise using a treadmill or recumbent stepper.
Intervention Type
Other
Intervention Name(s)
Sham priming
Intervention Description
Auditory stimulation.
Primary Outcome Measure Information:
Title
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Description
Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior muscles.
Time Frame
Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.
Title
Spinal H-reflex excitability using peripheral nerve stimulation (PNS)
Description
Peripheral nerve stimulation (PNS) will be used to assess the H reflexes excitability from the soles muscles.
Time Frame
Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.
Title
Motor control
Description
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.
Time Frame
Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.
Secondary Outcome Measure Information:
Title
Gait speed
Description
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-meter walk test (10MWT).
Time Frame
Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.
Title
Muscle strength
Description
An estimate of maximum ankle muscle force will be obtained for three trials of dorsiflexion and plantarflexion contractions using a force transducer.
Time Frame
Change from baseline to immediately after priming, to 30 minutes after priming, and to 60 minutes after priming.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangeetha Madhavan, PT, PhD
Phone
312-355-2507
Email
smadhava@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan, PT, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Plasticity Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan, PT, PhD
Email
smadhava@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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