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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

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GRASSP

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

Group IV: Rapael glove with Sham dAIHActive Control2 Interventions

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

0 / 6Eligibility criteria met