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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02441179 |
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Date of registration:
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05/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients
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Scientific title:
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Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training: a Potential Therapy for Incomplete Spinal Cord Injury Patients |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02441179 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Angela A Navarrete-Opazo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Rehabilitación Infantil Teletón |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients = 18 years-old from "Instituto Teletón Santiago" and "Hospital Clínico Mutual
de seguridad".
2. C5 to T12 spinal cord injury, classified as ISNCSCI grades C and D
3. Traumatic and non-traumatic, non-progressive lesions
4. Onset > 6 months
5. Ability to ambulate with or without assistive devices
6. Ability to follow verbal or visual commands
7. Signed informed consent
Exclusion Criteria:
1. Orthopedic injuries that are unstable
2. Osteoporosis with high risk of pathological fracture
3. Cutaneous lesions and/or pressure ulcers
4. Joint contractures
5. Cardiopulmonary diseases
6. Body weight exceeding 150 Kg
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injuries
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Intervention(s)
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Other: Acute Intermittent Hypoxia
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Other: Body weight-assisted treadmill training
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Other: Sham Protocol
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Primary Outcome(s)
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Gait Speed With 10-Meter Walk Test
[Time Frame: Change from baseline in gait speed five days after daily IH.]
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Secondary Outcome(s)
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Gait Endurance With the 6-Minute Walk Test
[Time Frame: Change from baseline in gait indurance five days after daily IH.]
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Learning and Memory With the Complutense Verbal Learning Test (TAVEC)
[Time Frame: Episodic verbal memory at week 4.]
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Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale
[Time Frame: Muscle tone at week 4.]
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Percentage of Subjects With Worsening Pain Perception on the "The Visual Analog Test"
[Time Frame: Pain perception at week 4]
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Gait Speed With the Timed up and go Test
[Time Frame: Change from baseline in gait speed five days after daily IH.]
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Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test
[Time Frame: Episodic visual memory at week 4.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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