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

NCT07113457 | Active Not Recruiting

• 2 other identifiers: STU00223882R21NS130367-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 function.

Conditions

Stroke

Keywords

stroke; hypoxia; spasticity; aih; ultrasound

Outcome Measures

Primary Outcomes (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

  30 minutes following intervention

Secondary Outcomes (4)

• Stretch reflex measurement:

  30 minutes following intervention

• Surface EMG measurement

  30 minutes following intervention

• EKG

  Continuously throughout intervention up to 30 minutes post intervention

• Symptom Checklist

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

Study Arms (1)

Hypoxia

EXPERIMENTAL

Participants 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.

Other: Acute Intermittent Hypoxia (AIH)

Interventions

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

Hypoxia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke; Hypoxia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations

Study Officials

• William Z Rymer, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 8, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of study conclusions
• Access Criteria: Study staff only has access to the full data sets and will provide relevant data upon request

Locations

US (1)