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StrokeNCT07113457

Assessing Upper Extremity Function in Chronic Stroke Survivors Through Acute Intermittent Hypoxia

A study testing Acute Intermittent Hypoxia (AIH) in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Here we aim to observe effects of acute intermittent hypoxia in persons who have experienced a single stroke. We have previously shown this technique to be safe and effective at increasing strength in persons with disabilities, and here are aiming to determine the mechanism of how the breathing method modulates motor… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Acute Intermittent Hypoxia (AIH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
2 Jun 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A first time, unilateral, ischemic, hemispheric stroke, confirmed by MRI
  • Chedoke stage of hand assessment >= 3
  • Ability to open and close affected hand
  • Able to understand and communicate in english
  • Able to independently consent
  • over 6 months post stroke
Show all 10Show fewer
  • Must have a hemoglobin level above 10g/dl
  • Must have ability to leave research visit with a compainon/group trasportation
  • WOCBP must be comfortable confirming negative pregnancy prior to hypoxia
  • Must not be involved in any other research intervention study testing upper extremities

Who cannot join

  • History of prior neurological disorders
  • Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI greater than equal to 3
  • Severe Aphasisa
  • Pre-existing hypoxic pulmonary disease
  • Includes positive Covid-pneumonia diagnosis within 1 year of screening visit
  • Severe hypertension (>160/100)
  • Any ischemic cardiac disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Assessing Upper Extremity Function in Chronic Stroke Survivors: Enhancing Neural Recovery With Acute Intermittent Hypoxia

Here we aim to observe effects of acute intermittent hypoxia in persons who have experienced a single stroke. We have previously shown this technique to be safe and effective at increasing strength in persons with disabilities, and here are aiming to determine the mechanism of how the breathing method modulates motor function.

Read the detailed description

Here we aim to observe effects of acute intermittent hypoxia in persons who have experienced a single stroke. We have previously shown this technique to be safe and effective at increasing strength in persons with disabilities, and here are aiming to determine the mechanism of how the breathing method modulates motor function.

Conditions
Stroke
Being tested
Acute Intermittent Hypoxia (AIH)
Keywords
stroke, hypoxia, spasticity, aih, ultrasound
Medical subject headings
Stroke, Hypoxia, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute Intermittent Hypoxia (AIH)Other

    This intervention involves breathing lowered levels of oxygen (similar to those experienced on a tall mountain) for 60 seconds at a time. This is immediately followed by 60 seconds of breathing normal room air. These bouts are repeated approximately 15 times. For the intervention, the participant is fitted with a non-rebreathing mask which supplies the two different air levels

Study groups in NCT07113457
Study groupRoleWhat they receive
HypoxiaExperimentalParticipants in this arm will receive approximately 15 bouts of acute intermittent hypoxia. This intervention involves breathing lowered levels of oxygen (similar to being on a tall mountain) for 60 seconds at a time, followed by 60 seconds of room air. Participants will be assessed following the intervention.
Receives: Other: Acute Intermittent Hypoxia (AIH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Joint Force Measurement

    The KAIST Upper Limb Synergy Investigation System (KULSIS) will be utilized. KULSIS was developed in collaboration with Neuro-

    Figure 1: Design of the KULSIS Rehabilitation Engineering Lab at Korea Advanced Institute of Science and Technology, South Korea (Figure 1). It comprises a modular hand and wrist attachment, which connects to a linear actuator. To construct the linear actuator, ball-screw type linear motion module (RS-075N-Z05PR, Robostar, South Korea) was combined with a 100 W AC servo motor (SGM7J-01AFD2C, Yaskawa, Japan). The linear actuator has stroke range of 400 mm, which is ample for adjusting the position of modular hand or wrist attachment to the participant's upper arm before the outcome assessment. Once adjusted, the power of linear actuator will be turned off to fix the position.

    A six degrees of freedom (DOF) Force/Torque sensor (Series Delta, ATI-Inc. Apex, NC, USA) is positioned between the module and the linear actuator to measure the force and torque applie

    Measured: 30 minutes following intervention

Secondary outcomes (4)

  1. Stretch reflex measurement:

    Stretch reflex thresholds will be assessed using a custom-designed tendon tapper system (Figure 2.A) based on a Linmot® linear motor (Linmot S.A., Spreitenbach, Switzerland). This system includes a stator and slider with integrated position sensing via a Hall effect sensor, ensuring precise control of tendon indentations and taps. The motor is mounted on a micrometer-driven positioner (Velmex, Bloomfield, NY, USA) for reliable placement of the tapper on the biceps brachii tendon. A multiaxial load cell (Series Nano17, ATI Industrial Automation, Apex, NC, USA) is attached at the tapping end to record applied forces and the resultant reflex responses. Additionally, the tendon tapper integrates a wireless ultrasound device(Figure 2.B) at its tip to provide real-time transverse imaging of the tissue composition surrounding the distal biceps tendon. The ultrasound device features an image resolution of 384 pixels (width) by 400-600 pixels (depth), corresponding to a physical size of 38.4 m

    Measured: 30 minutes following intervention

  2. Surface EMG measurement

    Surface EMG signals will be recorded using two systems to capture muscle activity during isometric contractions. The Bagnoli-8 EMG system (Delsys Inc, Boston, MA, USA), equipped with standard wired bipolar surface EMG electrodes, will provide localized muscle activity measurements. Additionally, high-density surface EMG (HDsEMG) recordings will be conducted using a 128-channel Refa system (TMSi; Oldenzaal, NL) with an 8×8 electrode grid (8.5 mm inter-electrode distance) to map spatially distributed muscle activity with high resolution (Figure 3). These complementary systems will allow a comprehensive assessment of muscle activation patterns during the study.

    Measured: 30 minutes following intervention

  3. EKG

    Standard bedside monitoring- a 2-lead tracing to identify dysrhythmias. EKG to be performed throughout hypoxia administration. 12 lead ECG to be performed at visit 1 at resting state with no other ongoing activities

    Measured: Continuously throughout intervention up to 30 minutes post intervention

  4. Symptom Checklist

    A simple yes/no subjective checklist will be asked and repeated to the subject. Specifically: Chest pain, Shortness of breath, Light headedness, neck pain, dizziness, arm pain, sweaty, sensory changes, increased weakness

    Measured: at each time point: 2, 6, 14, 24 and 30mins from the beginning of the hypoxia session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start2 Jun 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07113457
Sponsor's protocol ID
STU00223882
Other IDs
R21NS130367-01
Status last verified
Mar 2026
First submitted
22 Jul 2025
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified results will be shared upon request

Questions about this trial

What is this clinical trial studying?

A study testing Acute Intermittent Hypoxia (AIH) in people with Stroke, run by Shirley Ryan AbilityLab 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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Joint Force Measurement (time frame: 30 minutes following intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07113457.

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 20 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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