Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-24 @ 8:20 AM
Study NCT ID:
NCT03262766
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2017-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Daily Intermittent Hypoxia and Task-Specific Upper Limb Training in Persons With Chronic Incomplete SCI
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to investigate the effectiveness of a combinatorial therapy of breathing low oxygen in short bursts-acute intermittent hypoxia (AIH) and upper limb training on arm strength and function, and comparing it with individual treatments in persons with spinal cord injuries.
The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone.
To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.
The investigators hypothesize that a combinatorial intervention with AIH therapy + upper limb training will be significantly more effective in improving hand function, compared to individual treatments alone.
To test this hypothesis, the investigators will determine the impact of combined daily AIH therapy and high-repetition task-specific upper extremity training on arm strength and hand dexterity in persons with spinal cord injuries.
Detailed Description:
The objective of this research project is to determine the effect of a 5-day intervention with daily acute intermittent hypoxia (AIH) therapy, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI.
Previous work already determined that breathing low levels of oxygen for short periods of time (also known as acute intermittent hypoxia) can improve lower limb motor function in persons with spinal injury. Specifically, this study is being done to determine if pre-treatment with intermittent hypoxia can enhance the beneficial effects of upper limb training on the restoration of limb function in persons with spinal injury.
This is a blinded study, which means that the subject will not know which treatment they are receiving. They will either receive intermittent periods of low oxygen (hypoxia) or a session composed of only normal room air. They will be randomly assigned to a treatment based on chance. Neither the subject nor the researcher chooses the assigned group. They will have an equal chance of being in either group.
The participant will receive a daily 5-day intervention with either acute intermittent hypoxia (AIH) therapy or room air, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI. This will be preceded by a baseline testing visit prior to the intervention, and followed by a 4 week follow up period to assess the effects of the interventions over time.
The total duration of participation in the study intervention protocol is 1 week. Including the follow up period, the subjects will participate for a total of 6 weeks.
Previous work already determined that breathing low levels of oxygen for short periods of time (also known as acute intermittent hypoxia) can improve lower limb motor function in persons with spinal injury. Specifically, this study is being done to determine if pre-treatment with intermittent hypoxia can enhance the beneficial effects of upper limb training on the restoration of limb function in persons with spinal injury.
This is a blinded study, which means that the subject will not know which treatment they are receiving. They will either receive intermittent periods of low oxygen (hypoxia) or a session composed of only normal room air. They will be randomly assigned to a treatment based on chance. Neither the subject nor the researcher chooses the assigned group. They will have an equal chance of being in either group.
The participant will receive a daily 5-day intervention with either acute intermittent hypoxia (AIH) therapy or room air, either alone or coupled with task-specific training, on upper extremity function in individuals with chronic, incomplete SCI. This will be preceded by a baseline testing visit prior to the intervention, and followed by a 4 week follow up period to assess the effects of the interventions over time.
The total duration of participation in the study intervention protocol is 1 week. Including the follow up period, the subjects will participate for a total of 6 weeks.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: