StrokeNCT05919043
Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
A study testing Upper limb-based movement priming (UL-priming) and Lower limb-based movement priming (LL-priming) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Upper limb-based movement priming (UL-priming) and Lower limb-based movement priming (LL-priming)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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, 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.
- Conditions
- Stroke
- Being tested
- Upper limb-based movement priming (UL-priming), Lower limb-based movement priming (LL-priming), Sham priming
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb-based movement priming (UL-priming)Other
Repetitive upper limb movements administered to the beat of a metronome.
Lower limb-based movement priming (LL-priming)Other
Repetitive lower limb movements administered to the beat of a metronome.
Sham primingOther
Auditory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Upper limb-based movement priming (UL-priming) |
| Lower limb-based movement priming (LL-priming) | Active comparator | Participants will perform rhythmic, symmetric, bilateral plantarflexion and dorsiflexion movements. Receives: Other: Lower limb-based movement priming (LL-priming) |
| 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. Receives: Other: Sham priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately after priming and to 24 hours after priming.
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.
Measured: Change from baseline to immediately after priming and to 24 hours after priming.
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.
Measured: Change from baseline to immediately after priming and to 24 hours after priming.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jul 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangeetha Madhavan, University of Illinois Chicago
- Investigators
- Sangeetha Madhavan, PT, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919043
- Sponsor's protocol ID
- 2023-0070
- Status last verified
- Nov 2024
- First submitted
- 1 May 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb-based Movement Priming for Lower Limb Neuroplasticity & Motor Recovery in Stroke
- ClinicalTrials.gov ID
- NCT05919043
- Acronym / sponsor ID
- 2023-0070
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper limb-based movement priming (UL-priming) | Experimental | Other: 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). |
| Lower limb-based movement priming (LL-priming) | Active comparator | Other: Lower limb-based movement priming (LL-priming)Participants will perform rhythmic, symmetric, bilateral plantarflexion and dorsiflexion movements. |
| Sham priming | Sham comparator | Other: Sham primingParticipants will listen to a 1 Hz metronome for 20 minutes as a form of auditory stimulation during the sham priming session. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper limb-based movement priming (UL-priming)Repetitive upper limb movements administered to the beat of a metronome. | Other | Upper limb-based movement priming (UL-priming) |
| Lower limb-based movement priming (LL-priming)Repetitive lower limb movements administered to the beat of a metronome. | Other | Lower limb-based movement priming (LL-priming) |
| Sham primingAuditory stimulation. | Other | Sham priming |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeetha Madhavan, PT, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb-based movement priming (UL-priming) and Lower limb-based movement priming (LL-priming) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticomotor excitability using transcranial magnetic stimulation (TMS) (time frame: Change from baseline to immediately after priming and to 24 hours after priming.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.