A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury (HANDS)
Status
Active, not recruiting
Conditions
Spinal Cord Injuries
Treatments
Other: Rapael Glove
Procedure: Massed Practise
Other: Acute Intermitted Hypoxia
Details and patient eligibility
About
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.
Full description
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.
Enrollment
121 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
121 participants in 5 patient groups, including a placebo group
Massed practice training with dAIH
Experimental group
Description:
Seek to address gross upper extremity movements, grip and pinch strength, and coordination.The ultimate goal of the session is to achieve a total of 300 repetitions during training.
Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.
Treatment:
Procedure: Massed Practise
Other: Acute Intermitted Hypoxia
Massed practice training with Sham dAIH
Experimental group
Description:
Seek to address gross upper extremity movements, grip and pinch strength, and coordination.The ultimate goal of the session is to achieve a total of 300 repetitions during training.
Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.
Treatment:
Procedure: Massed Practise
Other: Acute Intermitted Hypoxia
Rapael glove with dAIH
Experimental group
Description:
The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement, hand function, and dexterity. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. The number of total repetitions and activity outcomes will be recorded.
Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.
Treatment:
Other: Acute Intermitted Hypoxia
Other: Rapael Glove
Rapael glove with Sham dAIH
Active Comparator group
Description:
The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement, hand function, and dexterity. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. The number of total repetitions and activity outcomes will be recorded.
Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.
Treatment:
Other: Acute Intermitted Hypoxia
Other: Rapael Glove
No training with dAIH
Placebo Comparator group
Description:
Once fitted with the mask, initial recordings of heart rate, blood pressure, and arterial oxygen saturation (SpO2) will be taken. The sequence of hypoxia will consist of 60- 90 seconds of 9-10% O2 (FiO2 0.09), alternating with 60- 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes, to maintain SpO2 at 80-90%.
Hearth rate and pulse oximetry will be continuously monitored throughout, and recording will be taken at each alteration in sequence. Blood pressure will be taken upon completion of the total sequence
Treatment:
Other: Acute Intermitted Hypoxia
Trial contacts and locations
3
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Central trial contact
william z rymer; Alexander Barry
Data sourced from clinicaltrials.gov
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