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A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury (HANDS)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Intermitted Hypoxia
Massed Practise
Rapael Glove
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

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

Inclusion:

  1. History of a non-progressive spinal cord injury, at or below C2, and at or above T1.
  2. Between the ages of 18 - 75 years.
  3. 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.
  4. 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.
  5. Ability to understand and the willingness to sign an informed consent.
  6. At least a 10% change in isometric elbow strength above baseline, after a single bout of Acute Intermittent Hypoxia (AIH), during screening.

Exclusion:

  1. 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.
  2. Women who are currently pregnant/nursing or planning on becoming pregnant.
  3. Individuals with a tracheostomy or who utilize mechanical ventilation.
  4. Individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function.
  5. 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.
  6. Documented sleep apnea.
  7. Orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity.
  8. Traumatic brain injury or other neurological conditions that would impact the study.
  9. Blood hemoglobin levels less than 10g/dL.

Sites / Locations

  • Edward Hines, Jr. VA HospitalRecruiting
  • Shirley Ryan AbilityLabRecruiting
  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Massed practice training with dAIH

Massed practice training with Sham dAIH

Rapael glove with dAIH

Rapael glove with Sham dAIH

No training with dAIH

Arm 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%.

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%.

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%.

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%.

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

Outcomes

Primary Outcome Measures

GRASSP
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is an extensive and validated impairment and functional measure which is able to detect subtle neurologic changes in individuals with spinal cord injury. Specifically, it evaluates the domains of sensation, strength, quality of different grip patterns and the ability to complete a variety of functional tasks.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2018
Last Updated
May 4, 2022
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT03644277
Brief Title
A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury
Acronym
HANDS
Official Title
HANDS: A Multi-Center Clinical Trial to Evaluate the Effectiveness of Intermittent Hypoxia Therapy in Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 29, 2023 (Anticipated)
Study Completion Date
June 29, 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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Upon enrollment in the study, participants will be randomly assigned to one of five groups, including: massed practice training with dAIH, massed practice training with Sham dAIH, Rapael glove with dAIH, Rapael glove with Sham dAIH, and no training with dAIH.
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massed practice training with dAIH
Arm Type
Experimental
Arm 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%.
Arm Title
Massed practice training with Sham dAIH
Arm Type
Experimental
Arm 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%.
Arm Title
Rapael glove with dAIH
Arm Type
Experimental
Arm 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%.
Arm Title
Rapael glove with Sham dAIH
Arm Type
Active Comparator
Arm 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%.
Arm Title
No training with dAIH
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Acute Intermitted Hypoxia
Other Intervention Name(s)
dAIG
Intervention Description
Subjects will be fitted with a latex-free full non-rebreather mask with a custom neoprene head strap, mask and oxygen delivery system are commonly used for altitude training. The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask.
Intervention Type
Procedure
Intervention Name(s)
Massed Practise
Intervention Description
Address gross upper extremity movements, grip and pinch strength, and coordination. Tasks utilized may include, but are not limited to: lifting a weighted can, squeezing, cutting paper, popping bubble wrap, translating different resistance clothespins, etc. The ultimate goal of the session is to achieve a total of 300 repetitions during training. Task difficulty may be progressed (making it more difficult), if the participant is able to achieve >100 repetitions in less than 15 minutes, on two different occasions. A task may be made easier if the participant is unable to achieve 50 repetitions of a task within 15minutes. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for a task to be deemed successful, increasing/decreasing the size of the object used. The number of total repetitions and any item progressions will be recorded.
Intervention Type
Other
Intervention Name(s)
Rapael Glove
Intervention Description
The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement and hand function during a 45 minute session. Additional time may be required for device set up and activity selection/modification. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. Tasks will be modified based on participants' perceived fatigue and challenge levels, as determined by a rating from 0-10. The participant goal will be to maintain the task difficulty between a 5-8/10 range. This would depict a moderate to difficult task rating, but an ability to complete the task. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for task success, and increasing the duration of contraction. The number of total repetitions and activity outcomes will be recorded.
Primary Outcome Measure Information:
Title
GRASSP
Description
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is an extensive and validated impairment and functional measure which is able to detect subtle neurologic changes in individuals with spinal cord injury. Specifically, it evaluates the domains of sensation, strength, quality of different grip patterns and the ability to complete a variety of functional tasks.
Time Frame
up to 3 months

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Barry
Phone
312-238-1435
Email
abarry@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
william z rymer
Phone
312 238-3919
Email
zrymer@sralab.org
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Perez, PT, PhD
Phone
312-238-2886
First Name & Middle Initial & Last Name & Degree
Monica Perez, PT, PhD
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
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LieghAnn Martinez
Phone
973-324-3557
Email
lmartinez@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Gail Forrest, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury

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