Health TrialsbyHealthPanel

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

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSpaulding Rehabilitation Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 and 75 years (the latter to reduce likelihood of heart disease)

Medical clearance to participate

Lesion at or below C2 and above T12 with non-progressive etiology

Classified as motor-incomplete with visible volitional leg movement

Disqualifiers

Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)

Pregnant women because of the unknown affects of AIH on pregnant women and fetus

History of seizures, brain injury, and/or epilepsy

Undergoing concurrent physical therapy

Trial design

Design model

Crossover

Treatments tested in this trial

  • AIH

    Other intervention

    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 intervention

    30 minutes of walking practice consisting of 5 repetitions of 6-minute walks

  • Strength

    Other intervention

    30 minutes of isometric ankle plantar flexion torque practice broken into 3 sets of 10 repetitions

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: AIH/WalkActive comparator 2 interventions
Group B: AIH/StrengthActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in overground walking endurance

Endurance will be measured as the distance walked during 2 min and 6 min (6MWT).

Time frame
Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)
2

Change in muscle strength

Strength will be assessed as the maximum isometric torque produced by the ankle and measured by a 6 degrees-of-freedom (DOF) load cell.

Time frame
Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)

Secondary outcomes

1

Change in overground walking speed

Speed will be assessed by the time required to walk 10 meters (10MWT).

Time frame
Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

Foundation Wings For Life

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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