Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

Summary

Spinal cord injury (SCI) interrupts descending synaptic pathways from brainstem premotor neurons to spinal motor neurons, thereby paralyzing muscles below the neurological level. In recent years, considerable evidence has demonstrated that acute intermittent hypoxia (AIH) elicits plasticity in the spinal cord and strengthens spare synaptic pathways which is expressed as respiratory and somatic functional recovery in animals and humans suffering from incomplete SCI. The fundamental hypothesis guiding this project is that AIH-induced motor plasticity can be "harnessed" to improve walking capacity in incomplete SCI patients, classified as C and D categories according to International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The inclusion criteria include patients \> 18 years-old, with traumatic or non-traumatic, non-progressive incomplete SCI, onset \> 6 months, neurological level C5-T12, with walking ability with or without assistive devices, without joint contractures, orthopedic injuries, osteoporosis, cutaneous lesions, cardiopulmonary complications and a body weight below 150 Kg. A randomized, triple-blind, placebo-controlled parallel design study will be done including 100% of patients fulfilling the criteria. Participants will receive repetitive acute intermittent hypoxia (rAIH: 15 episodes of 90 second 9% inspired oxygen interspersed with 90-second normoxia) or repetitive continued normoxia (rSham: 21% inspired oxygen) combined with 45 minutes body weight-supported treadmill training on 5 consecutive days and then three times per week for 3 weeks. Primary outcome measurement will be the 10-meter walking test. Secondary outcome measurements include the 6-minute walking test, timed up and go test, body/weight load, modified ashworth scale and visual analog scale. All outcomes will be measured before beginning the protocol (baseline), after five days of AIH/Sham (D5), weekly up to the end of the study (W2-W4), and a post-study follow-up for 2 weeks (F1-F2). Aditionally, cognitive assesment before and after the study will be performed using the "Figura compleja de Rey-Osterrieth" and the "Test de aprendizaje verbal España Complutense (TAVEC)". Repetitive AIH and body weight-supported treadmill training may represent a novel, safe, and noninvasive potential therapy to partially restore walking function in incomplete sub-acute and chronic SCI patients, a population with limited, if any, potential for improved function.

Conditions

• Spinal Cord Injuries

Interventions

OTHER

Acute Intermittent Hypoxia

Patients will breath 9% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.

OTHER

Body weight-assisted treadmill training

Patient´s gait will be trained through a weight-assisted treadmill (BWSTT). All recruited patients will start BWSTT at a speed of 0.6 km/hr. The physical therapist will manually correct posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training will be done immediately after the protocol of AIH or Sham and it will last 45 minutes.

OTHER

Sham Protocol

It consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.

Sponsors & Collaborators

• Hospital Clinico Mutual de Seguridad

  collaborator OTHER

• Sociedad Pro Ayuda del Niño Lisiado

  lead OTHER

Principal Investigators

• Angela A Navarrete-Opazo, MD, PhD · Instituto de Rehabilitación Infantil Teletón

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2015-10-31

Completion

2015-10-31

Countries

• Chile

Study Locations