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Combined Hypoxia Therapy and Rehabilitation for Spinal Cord Injury (HANDS Trial)
N/A
Waitlist Available
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
HANDS Trial Summary
This trial will investigate whether combining daily hypoxia therapy with massed practice training can improve upper-body function in people with chronic incomplete cervical spinal cord injuries.
Who is the study for?
This trial is for adults aged 18-75 with chronic incomplete cervical spinal cord injury, at least six months post-injury. It's open to those who've had no symptom regression for two years and can show some hand muscle control. Pregnant or nursing women and individuals with certain cardiovascular, respiratory, or metabolic conditions are excluded.Check my eligibility
What is being tested?
The study tests the combination of daily acute intermittent hypoxia therapy (dAIH) and massed practice training on improving hand function. Participants will also use a Rapael Glove—a smart rehabilitation device—to aid recovery.See study design
What are the potential side effects?
Potential side effects may include discomfort from the hypoxia therapy such as lightheadedness or headache, fatigue from intensive practice sessions, and possible skin irritation from wearing the Rapael Glove.
HANDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My elbow strength improved by at least 10% after a special breathing test.
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I can voluntarily move my hand muscles and can perform at least one type of grasp.
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I have a stable spinal cord injury between my neck and upper back.
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I am not pregnant, nursing, or planning to become pregnant.
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I have been diagnosed with a serious heart, lung, or blood vessel condition.
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I am between 18 and 75 years old.
HANDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GRASSP
HANDS Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Rapael glove with dAIHExperimental Treatment2 Interventions
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%.
Group II: Massed practice training with dAIHExperimental Treatment2 Interventions
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%.
Group III: Massed practice training with Sham dAIHExperimental Treatment2 Interventions
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%.
Group IV: Rapael glove with Sham dAIHActive Control2 Interventions
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%.
Group V: No training with dAIHPlacebo Group1 Intervention
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
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,764 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals below the age of 85 eligible for enrollment in this clinical experiment?
"To be eligible for this medical research, participants must fall within the 18 to 75 year old range. For those outside of that age group there are 138 trials available for minors and 732 studies catered towards seniors."
Answered by AI
Who is the ideal demographic for this scientific research?
"This clinical trial is accepting 125 qualified participants with spinal cord injuries aged 18 to 75. To be considered, the following conditions must be met: 6-month window from time of injury for traumatic SCIs; non-traumatic associated symptoms must not have regressed in two years as per self-report or medical monitor's judgement; GRASSP assessment score of at least 2 on one upper limb muscle (cylindrical grasp, lateral key pinch and tip to tip pinch); no pregnancy/nursing or plans thereof for women; non-progressive SCI below C2 and above T1; cardiovascular health clearances (congestive"
Answered by AI
What is the current participant size of this research endeavor?
"Affirmative. Clinicaltrials.gov records demonstrate that this medical research is actively recruiting patients, with the trial's initial posting occurring on July 1st 2018 and most recent update being May 4th 2022. The study requires 125 participants from 3 different sites."
Answered by AI
Are there opportunities to join this experiment at present?
"Affirmative. According to clinicaltrials.gov, this research protocol was posted on July 1st 2018 and recently updated in May 4th 2022. 125 participants are required from 3 centres for the trial's continuation."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Did not meet criteria
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