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AIH-induced Walking Recovery After Subacute SCI

NCT02632422 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-10-31

No results posted yet for this study

Summary

The purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.

Conditions

  • Spinal Cord Injury

Interventions

OTHER

Daily acute intermittent hypoxia (dAIH)

Each participant will be exposed to 10 sessions of daily acute intermittent hypoxia (dAIH) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily acute intermittent hypoxia (dAIH).

OTHER

dSHAM

Each participant will be exposed to 10 sessions of daily room air (dSHAM) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily room air (dSHAM).

OTHER

Walking

Participants will participate in 10 days of walking practice sessions. Walking practice sessions will immediately follow (within 60 minutes) the breathing intervention during training visits and will last for 60 minutes. Walking practice will incorporate 5 walking-related tasks: 1. walking balance (e.g., walking with turns) 2. skilled walking tasks (e.g., negotiating obstacles) 3. walking with secondary task (e.g., walking and talking) 4. endurance 5. speed

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Randy Trumbower, PT, PhD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2023-07-07
Completion
2027-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632422 on ClinicalTrials.gov