Clinical trial NCT05919043: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: Corticomotor excitability using transcranial magnetic stimulation (TMS)
timeFrame: Change from baseline to immediately after priming and to 24 hours after priming.
measure: Spinal H-reflex excitability using peripheral nerve stimulation (PNS)
timeFrame: Change from baseline to immediately after priming and to 24 hours after priming.
measure: Muscle Strength
timeFrame: Change from baseline to immediately after priming and to 24 hours after priming.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Brain Plasticity Lab
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sangeetha Madhavan, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: