search
Back to results

Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Upper extremity training/Armeo Spring
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Injuries focused on measuring hypoxia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of a non-progressive spinal cord injury, inclusive of levels of C1-T1.
  • Etiology of spinal cord injury is non-progressive in nature
  • Be able to demonstrate some hand muscle activation, or use of a tenodesis grasp (wrist extension)
  • At least 6 months post injury
  • Participants do NOT have to stop taking antispasticity medications to participate in the study.
  • Must be tested for anemia with a value of at least 10g/dl (for both men and women).
  • Patients will be recommended to their primary care physician to correct anemia if low levels are detected
  • Blood pressure must fall within this range- high: 160/110mmHg low: 85/55 mmHg
  • Must be asymptomatic (no dizziness, lightheadedness, etc)

Exclusion Criteria:

  • Medical conditions, including: 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 or planning on becoming pregnant
  • Current tracheostomy placement
  • Utilization of mechanical ventilator for breathing
  • Current diagnosis of obstructive sleep apnea
  • Orthopedic injuries or surgeries that would limit participation
  • Concurrent participation in another research study or therapy services
  • Comorbid traumatic brain injury or other neurologic injuries that would impact cognition

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

No Intervention

Arm Label

Acute Intermittent Hypoxia (AIH) treatment

AIH in combination with upper extremity training

Sham AIH therapy in combination with upper extremity training

Sham AIH therapy

Arm Description

The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment.

The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment. In addition to this upper extremity training will be given using an upper-limb robotic rehabilitation device.

Sham hypoxia followed by upper extremity training will be given using an upper-limb robotic rehabilitation device (Armeo Spring®, Hocoma AG, Switzerland). Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Sham hypoxia

Outcomes

Primary Outcome Measures

GRASSP
Graded Redefined Assessment of Strength, Sensation and Prehension

Secondary Outcome Measures

9-hole peg test
coordination
grip strength
hand strength

Full Information

First Posted
March 12, 2018
Last Updated
July 25, 2022
Sponsor
Shirley Ryan AbilityLab
search

1. Study Identification

Unique Protocol Identification Number
NCT03643770
Brief Title
Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Official Title
Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, there are a variety of approaches utilized in attempts to improve upper extremity function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or surgical interventions. In addition, regenerative and restorative therapies, such as: epidural stimulation, functional electrical stimulation, and stem cell therapies, show promise in animal models, but are not ready for clinical translation. Subsequently, there is a clear need to develop new strategies that can stimulate spinal plasticity and strengthen existing synaptic connections in order to maximize the benefits of training paradigms. This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen). Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.
Detailed Description
This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen). Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
4 randomized groups: Acute Intermittent Hypoxia (AIH) treatment, AIH in combination with upper extremity training, Sham AIH therapy in combination with upper extremity training and Sham AIH therapy
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Intermittent Hypoxia (AIH) treatment
Arm Type
No Intervention
Arm Description
The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment.
Arm Title
AIH in combination with upper extremity training
Arm Type
Active Comparator
Arm Description
The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment. In addition to this upper extremity training will be given using an upper-limb robotic rehabilitation device.
Arm Title
Sham AIH therapy in combination with upper extremity training
Arm Type
Active Comparator
Arm Description
Sham hypoxia followed by upper extremity training will be given using an upper-limb robotic rehabilitation device (Armeo Spring®, Hocoma AG, Switzerland). Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.
Arm Title
Sham AIH therapy
Arm Type
No Intervention
Arm Description
Sham hypoxia
Intervention Type
Combination Product
Intervention Name(s)
Upper extremity training/Armeo Spring
Intervention Description
Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.
Primary Outcome Measure Information:
Title
GRASSP
Description
Graded Redefined Assessment of Strength, Sensation and Prehension
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
9-hole peg test
Description
coordination
Time Frame
4 weeks
Title
grip strength
Description
hand strength
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of a non-progressive spinal cord injury, inclusive of levels of C1-T1. Etiology of spinal cord injury is non-progressive in nature Be able to demonstrate some hand muscle activation, or use of a tenodesis grasp (wrist extension) At least 6 months post injury Participants do NOT have to stop taking antispasticity medications to participate in the study. Must be tested for anemia with a value of at least 10g/dl (for both men and women). Patients will be recommended to their primary care physician to correct anemia if low levels are detected Blood pressure must fall within this range- high: 160/110mmHg low: 85/55 mmHg Must be asymptomatic (no dizziness, lightheadedness, etc) Exclusion Criteria: Medical conditions, including: 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 or planning on becoming pregnant Current tracheostomy placement Utilization of mechanical ventilator for breathing Current diagnosis of obstructive sleep apnea Orthopedic injuries or surgeries that would limit participation Concurrent participation in another research study or therapy services Comorbid traumatic brain injury or other neurologic injuries that would impact cognition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Barrry
Phone
312-238-1435
Email
abarry@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Zev Rymer, MD
Email
zrymer@sralab.org
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Barry, MS, CCRC
Phone
312-238-1435
Email
abarry@sralab.org
First Name & Middle Initial & Last Name & Degree
William Z Rymer, MD/PhD

12. IPD Sharing Statement

Learn more about this trial

Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals With Spinal Cord Injury

We'll reach out to this number within 24 hrs