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Clinical Trials/NCT05919043
NCT05919043CompletedNot Applicable

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

University of Illinois at Chicago1 site in 1 country17 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Spinal H-reflex excitability using peripheral nerve stimulation (PNS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
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
  • •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

Arms & Interventions

Lower limb-based movement priming (LL-priming)

Active Comparator

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

Intervention: Lower limb-based movement priming (LL-priming) (Other)

Upper limb-based movement priming (UL-priming)

Experimental

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).

Intervention: Upper limb-based movement priming (UL-priming) (Other)

Sham priming

Sham Comparator

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

Intervention: Sham priming (Other)

Outcomes

Primary Outcomes

Spinal H-reflex excitability using peripheral nerve stimulation (PNS)

Time Frame: Change from baseline to immediately after priming and to 24 hours after priming.

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

Corticomotor excitability using transcranial magnetic stimulation (TMS)

Time Frame: Change from baseline to immediately after priming and to 24 hours after priming.

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

Muscle Strength

Time Frame: Change from baseline to immediately after priming and to 24 hours after priming.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sangeetha Madhavan

Professor, Physical Therapy

University of Illinois at Chicago

Study Sites (1)

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