Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT02323945
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AIH — OTHER
    Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FiO2) = 0.10±0.02 (hypoxia). Participants will receive treatment on 5 consecutive days.
  • Walk — OTHER
    30 minutes of walking practice consisting of 5 repetitions of 6-minute walks
  • Strength — OTHER
    30 minutes of isometric ankle plantar flexion torque practice broken into 3 sets of 10 repetitions

Study Details

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

Key Dates

Start date
Oct 31, 2014
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: AIH/Walk
    Subjects with chronic, motor-incomplete SCI receive acute intermittent hypoxia (AIH) with walking practice, then AIH with strength practice and compare their efficacy on enhancing strength and/or walking performance.
  • Active Comparator: AIH/Strength
    Subjects with chronic, motor-incomplete SCI receive AIH with strength practice, then AIH with walking practice and compare their efficacy on enhancing strength and/or walking performance.

Primary Outcome Measure

Change in overground walking endurance [ Time Frame: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation HospitalCambridgeMassachusetts02138
Randy D Trumbower, PT, PhD
[email protected]
(617) 952-6951
Melissa DeChellis, BA
[email protected]
(617) 952-6953

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By research site
Spaulding Rehabilitation Hospital· Cambridge, MA

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