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NCT Number: NCT03644277

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines, Jr. VA Hospital, Chicago, Illinois, United States

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About this study

Specific Aim 1: Evaluate the effectiveness of a combined intervention utilizing dAIH and massed practice upper extremity training on arm and hand function in individuals with incomplete tetraplegia.

Specific Aim 2: Evaluate the effectiveness of a combined intervention utilizing dAIH therapy and robotic rehabilitation device-administered upper-extremity training on arm and hand function in persons with incomplete tetraplegia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • History of a non-progressive spinal cord injury, at or below C2, and at or above T1.
  • Between the ages of 18 - 75 years.
  • 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.
  • 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.
  • Ability to understand and the willingness to sign an informed consent.
  • At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening.

Exclusion:

  • 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.
  • Women who are currently pregnant/nursing or planning on becoming pregnant.
  • Individuals with a tracheostomy or who utilize mechanical ventilation.
  • Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
  • 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.
  • Documented sleep apnea.
  • Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity.
  • Traumatic brain injury or other neurological conditions that would impact the study.
  • Blood hemoglobin levels less than 10g/dL.

Treatment and study plan

Acute Intermitted Hypoxia

Other

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.

Other names: dAIG

Massed Practise

Procedure

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.

Rapael Glove

Other

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.

Primary outcomes

  1. GRASSP

    Time frame: up to 3 months

    The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is an extensive and validated impairment and functional measure which is able to detect subtle neurologic changes in individuals with spinal cord injury.

    Specifically, it evaluates the domains of sensation, strength, quality of different grip patterns and the ability to complete a variety of functional tasks.

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

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

Acronym: HANDS

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Aug 23, 2018
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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