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AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM) for Spinal Cord Injury (BO2ST-II Trial)

N/A
Waitlist Available
Led By Randy Trumbower, PT, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 18 to 80 years of age
* medically stable with medical clearance from study physician to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 14 weeks
Awards & highlights

Summary

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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in walking recovery, assessed by 10 meter walk test (10MWT)
Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)
Secondary study objectives
Autonomic dysreflexia incidence rate
Change in bladder dysfunction, assessed by the Neurogenic Bladder Symptom Score (NBSS)
Change in bowel dysfunction, assessed by the Neurogenic Bowel Dysfunction Score (NBDS) v2.1
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Experimental Treatment2 Interventions
Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
Group II: Sham + WALKtSTIMPlacebo Group1 Intervention
Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
136 Previous Clinical Trials
11,000 Total Patients Enrolled
United States Department of DefenseFED
882 Previous Clinical Trials
331,873 Total Patients Enrolled
Brooks RehabilitationOTHER
14 Previous Clinical Trials
1,743 Total Patients Enrolled
~40 spots leftby Sep 2027
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