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ACTIVE NOT RECRUITING

NCT03644277

A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

Summary

The overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (dAIH), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical SCI.

Official title: HANDS: A Multi-Center Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individuals With Spinal Cord Injury

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2018-07-01

Completion Date

2026-07-01

Last Updated

2025-07-24

Healthy Volunteers

Conditions

Spinal Cord Injuries

Interventions

OTHER

Acute Intermitted Hypoxia

Subjects will be fitted with a latex-free full non-rebreather mask with a custom neoprene head strap, mask and oxygen delivery system are commonly used for altitude training. The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask.

PROCEDURE

Massed Practise

Address gross upper extremity movements, grip and pinch strength, and coordination. Tasks utilized may include, but are not limited to: lifting a weighted can, squeezing, cutting paper, popping bubble wrap, translating different resistance clothespins, etc. The ultimate goal of the session is to achieve a total of 300 repetitions during training. Task difficulty may be progressed (making it more difficult), if the participant is able to achieve \>100 repetitions in less than 15 minutes, on two different occasions. A task may be made easier if the participant is unable to achieve 50 repetitions of a task within 15minutes. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for a task to be deemed successful, increasing/decreasing the size of the object used. The number of total repetitions and any item progressions will be recorded.

OTHER

Rapael Glove

The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement and hand function during a 45 minute session. Additional time may be required for device set up and activity selection/modification. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. Tasks will be modified based on participants' perceived fatigue and challenge levels, as determined by a rating from 0-10. The participant goal will be to maintain the task difficulty between a 5-8/10 range. This would depict a moderate to difficult task rating, but an ability to complete the task. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for task success, and increasing the duration of contraction. The number of total repetitions and activity outcomes will be recorded.

Inclusion: 1. History of a non-progressive spinal cord injury, at or below C2, and at or above T1. 2. Between the ages of 18 - 75 years. 3. Time since injury must be at least 6 months if the injury was traumatic in nature. If the spinal cord injury is non-traumatic, participants must meet at least the initial 6-month criteria in addition to either no regression in symptoms for at least two years, per self-report or per medical monitor discretion. 4. Demonstrate voluntary motor activation in hand muscles, with a score of at least a 2 on at least one of the Prehension Ability grasp patterns of the GRASSP assessment (cylindrical grasp, lateral key pinch, and tip to tip pinch), on at least one upper extremity. 5. Ability to understand and the willingness to sign an informed consent. 6. At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening. Exclusion: 1. Diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis. 2. Women who are currently pregnant/nursing or planning on becoming pregnant. 3. Individuals with a tracheostomy or who utilize mechanical ventilation. 4. Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function. 5. Participants will be excluded if they have had a botulinum toxin injection to upper extremity musculature within the last 3 months. Participants will need to refrain from upper extremity botulinum toxin injections for the duration of the study. If participants wean off antispasticity medications to successfully complete the responsiveness to AIH screening session, they will need to refrain from the medications for the duration of the study. 6. Documented sleep apnea. 7. Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity. 8. Traumatic brain injury or other neurological conditions that would impact the study. 9. Blood hemoglobin levels less than 10g/dL.

Locations (3)

Edward Hines, Jr. VA Hospital

Chicago, Illinois, United States

Shirley Ryan AbilityLab