Combined Hypoxia Therapy and Rehabilitation for Spinal Cord Injury

(HANDS Trial)

Not currently recruiting at 2 trial locations

Overseen By william z rymer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Antispasticity medications

Disqualifiers: Heart failure, Hypertension, Diabetes, COPD, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy designed to help individuals with long-term, partial spinal cord injuries regain better use of their arms and hands. It combines short bursts of low oxygen therapy (Acute Intermittent Hypoxia) with exercises to improve upper body strength and coordination (Massed Practice). Participants will use a virtual reality glove (Rapael Glove) to perform tasks like throwing darts and catching a baseball. This trial may suit those who have had a spinal cord injury for over six months and can voluntarily move their hand muscles. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance daily life activities.

Will I have to stop taking my current medications?

The trial requires participants to stop taking antispasticity medications if they wean off them to complete the screening session. They must refrain from these medications for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that acute intermittent hypoxia (AIH) is generally safe and well-tolerated. Studies indicate that AIH does not cause lasting changes in heart or breathing rates, nor does it affect brain function or blood flow in the brain. AIH is non-invasive, meaning it does not involve surgery or procedures inside the body.

Previous research has demonstrated that massed practice, which involves a lot of repetition, is safe when combined with AIH. This approach aims to improve strength and coordination without causing harm.

In simpler terms, both treatments in this trial—AIH and massed practice—have been shown to be safe in other studies. They aim to help without causing major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Combined Hypoxia Therapy and Rehabilitation for Spinal Cord Injury trial because it explores the potential of using both acute intermittent hypoxia (AIH) and innovative rehabilitation techniques, like the Rapael Smart Glove, to enhance recovery. Unlike standard treatments that focus mostly on physical rehabilitation alone, this trial combines a virtual reality hand exoskeleton with controlled hypoxia sessions to potentially boost motor function and dexterity. AIH involves alternating between low and normal oxygen levels to stimulate the nervous system, which is a novel approach in spinal cord injury therapy. Researchers hope this unique combination could lead to more significant improvements in movement and coordination compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for improving upper-extremity function in individuals with chronic incomplete cervical spinal cord injury?

Research has shown that short periods of low oxygen (known as acute intermittent hypoxia, or AIH) can improve arm and hand function in individuals with long-term spinal cord injuries. In this trial, some participants will receive AIH combined with various rehabilitation methods. Studies suggest that AIH might also boost muscle strength and aid in walking recovery for those with partial spinal cord injuries. Evidence indicates that intensive practice, such as massed practice training, effectively enhances movement and strength in the upper body for individuals with partial neck injuries. Repetitive training improves coordination and movement, making it a promising therapy. Together, these treatments aim to support recovery and enhance daily life for people with long-term spinal cord injuries. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and the willingness to sign an informed consent.

My elbow strength improved by at least 10% after a special breathing test.

I can voluntarily move my hand muscles and can perform at least one type of grasp.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily acute intermittent hypoxia therapy (dAIH) combined with massed practice training to improve upper-extremity function

3 months

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute Intermitted Hypoxia
• Massed Practise
• Rapael Glove

Trial Overview

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.

How Is the Trial Designed?

Group I: Rapael glove with dAIH Experimental Treatment 2 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 dAIH Experimental Treatment 2 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 dAIH Experimental Treatment 2 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 dAIH Active Control 2 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 dAIH Placebo Group 1 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

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

This clinical trial will investigate the effects of daily acute intermittent hypoxia (AIH) on walking recovery in 85 participants with sub-acute spinal cord injury (SCI), aiming to determine if AIH can enhance recovery when combined with walking practice.

The study will assess various outcomes, including walking speed and endurance, while also monitoring safety measures like pain and spasticity, to evaluate the potential of AIH as a treatment to improve mobility in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily acute intermittent hypoxia to improve walking function in persons with subacute spinal cord injury: a randomized clinical trial study protocol. Naidu, A., Peters, DM., Tan, AQ., et al.[2020]

Daily acute intermittent hypoxia (AIH) combined with hand opening practice significantly improved hand dexterity and function in all six participants with chronic cervical spinal cord injury, as evidenced by better scores on the Box and Block Test and reduced times on the Jebsen-Taylor Hand Function Test.

The study suggests that AIH may enhance the effectiveness of rehabilitation by promoting neural plasticity, but further research is needed to determine the optimal dosage, safety, and long-term effects of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Trumbower, RD., Hayes, HB., Mitchell, GS., et al.[2022]

The study involved 35 participants with incomplete spinal cord injury, testing the effects of combined intermittent hypoxia and body weight-supported treadmill training over 4 weeks.

Results showed that while standing balance did not improve significantly, participants receiving intermittent hypoxia demonstrated significantly faster dynamic balance measures, indicating potential benefits for mobility in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Hypoxia and Locomotor Training Enhances Dynamic but Not Standing Balance in Patients With Incomplete Spinal Cord Injury. Navarrete-Opazo, A., Alcayaga, JJ., Sepúlveda, O., et al.[2018]

Acute intermittent hypoxia has shown promise as a therapeutic strategy to improve respiratory function in individuals with cervical spinal cord injuries, based on studies that demonstrate its potential to induce neuroplasticity and functional recovery.

Research in animal models has laid the groundwork for exploring the effects of acute intermittent hypoxia in human clinical studies, highlighting its potential to restore breathing function after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent hypoxia and respiratory recovery in pre-clinical rodent models of incomplete cervical spinal cord injury. Gonzalez-Rothi, EJ., Lee, KZ.[2021]

Acute intermittent hypoxia (AIH) is a safe and effective therapy that can enhance strength, walking speed, endurance, and dynamic balance in individuals with chronic, incomplete spinal cord injury (SCI).

AIH shows promise for promoting walking recovery through neuroplasticity mechanisms, but more research is needed to determine its effectiveness across larger groups and to identify optimal treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute intermittent hypoxia as a potential adjuvant to improve walking following spinal cord injury: evidence, challenges, and future directions. Tan, AQ., Barth, S., Trumbower, RD.[2022]

Citations

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sciencedirect.com

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