Low Oxygen Therapy to Enhance Walking Recovery After SCI.
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSpaulding Rehabilitation Hospital
About this trial
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury of different age groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 80 years of age
medically stable with medical clearance from study physician to participate
SCI at or below C1 and at or above L2 with at least some sensory or motor function preserved below the neurologic level
non-progressive etiology of spinal injury
Disqualifiers
severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation
< 24 on Mini-Mental Exam
severe recurrent autonomic dysreflexia
history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure > 150 mmHg)
Trial design
Design model
Parallel
Treatments tested in this trial
Daily acute intermittent hypoxia
Other interventionEach participant will be exposed to 16 sessions of daily acute intermittent hypoxia via air generators over the span of four weeks. 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).
Walking + tSTIM
DeviceIndividuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental treatment 2 interventions
Group B: Sham + WALKtSTIMSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.
Time frame
Through study completion, an average of 14 weeks2
Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)
Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Rate of change is the number of treatment sessions required to achieve an increase in 10MWT speed of at least the minimal clinically important difference (0.06 m/s) as compared to pre-treatment baseline.
Time frame
Through study completion, an average of 14 weeksSecondary outcomes
1
Change in walking recovery, assessed by 6 minute walk test (6MWT)
Participants perform the 6MWT at their fastest, most comfortable walking speed sustainable for 6 minutes. Distances will be recorded at 2 and 6 minutes. The test will be based upon the participant's ability to finish each assessment without human assistance. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.
Time frame
Through study completion, an average of 14 weeks2
Change in walking recovery, assessed by timed up-and-go (TUG) test
The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair. Participants will perform up to three trials of the TUG test. Average speed across TUG trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline
Time frame
Through study completion, an average of 14 weeks3
Change in pain severity, assessed by the Numeric Pain Rating Scale (NPRS)
Participants will report their pain level using the Numeric Pain Rating Scale. The scale is from 0 to 10; 0 being no pain and 10 being extreme pain. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.
Time frame
Through study completion, an average of 14 weeks4
Change in cognitive function, assessed by the California Verbal Learning Test (CVLT)
The CVLT is a brief, individually administered battery to measure cognitive decline or improvement and assesses verbal learning and memory for older adolescents and adults. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.
Time frame
Through treatment completion, an average of 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Spaulding Rehabilitation Hospital
Lead sponsor
United States Department of Defense
Collaborator
Brooks Rehabilitation
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov