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Clinical Trials/NCT04280484
NCT04280484
Completed
Not Applicable

Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis

Shirley Ryan AbilityLab1 site in 1 country10 target enrollmentJune 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis, Relapsing-Remitting
Sponsor
Shirley Ryan AbilityLab
Enrollment
10
Locations
1
Primary Endpoint
Voluntary Ankle Strength
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.

Registry
clinicaltrials.gov
Start Date
June 18, 2018
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Milap Sandhu

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

  • Have relapsing-remitting MS
  • Volitional ankle plantar flexion strength in at least one leg
  • Are relapse free for 30 days
  • Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)

Exclusion Criteria

  • Currently taking antispasticity medications,
  • Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
  • Pregnant or nursing women (safety for developing fetus or infant is unknown)
  • Cognitive concerns (must be able to consent to study, follow steps)

Outcomes

Primary Outcomes

Voluntary Ankle Strength

Time Frame: 60 minutes post-intervention

Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex

Secondary Outcomes

  • Symbol Digit Modalities Test(60 minutes post-intervention)
  • Electromyogram activity(60 minutes post-intervention)

Study Sites (1)

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