Spasticity in SCI Following Acute Intermittent Hypoxia
ConditionSpinal Cord Injuries (SCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZev Rymer
About this trial
This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18
Non-progressive spinal Cord injury at least 6 months prior
Level of injury between C1-C8
ISNCSCI ASIA classification C or D
Disqualifiers
Pre-existing hypoxic pulmonary disease
Positive Covid-Pneumonia diagnosis within 1 year of visit
Uncontrolled hypertension >140/90 mmHg
Individuals who are currently pregnant/nursing or planning on becoming pregnant
Trial design
Design model
Single group
Treatments tested in this trial
Acute Intermittent Hypoxia (AIH)
DeviceThis intervention involves breathing lowered levels of oxygen for 60 seconds, alternating with 60 seconds of room air breathing. Participants will be monitored and observed during the entire session for any changes in vital signs
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: AIH interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in reflex indentation threshold
Similar to a tendon tap that a doctor may perform, this study uses an automated tendon tapper to measure the level of indentation needed to elicit a reflex in the bicep muscle. The aim is to observe any changes in reflex threshold following the AIH intervention
Time frame
Day 1 of InterventionSecondary outcomes
1
Change in Modified Ashworth Scale - Elbow
The modified Ashworth scale is a measure of Spasticity, performed by a trained administrator. This test involves rapidly rotating the participant's arm and feeling the spastic muscle response. This assessment is scored from 0 to 4, with 0 indicating no spasticity, and 4 indicating a fully contracted limb
Time frame
Day 1 of intervention2
Grip Strength
Using a handheld dynamometer, maximum grip strength of participants will be measured
Time frame
Day 1 of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zev Rymer
Lead sponsor
Shirley Ryan AbilityLab
Sponsor institution
Source ClinicalTrials.gov