High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Marquette University
Study ID
NCT05735691
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • High-Intensity Treadmill Training — PROCEDURE
    Participants will walk on a treadmill at a speed that produces 70-80% of age-adjusted heart rate reserve or a rating of perceived exertion of 17/20. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.
  • Treadmill Training with Perturbations — PROCEDURE
    Participants will walk on a treadmill and a perturbation of the treadmill will be produced every 20s. Perturbations will randomly occur in the forward, backward, right or left directions, with a perturbation size set to 80% of stability threshold. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts with 2-3 minutes rest between bouts.
  • Standard Treadmill Training — PROCEDURE
    Participants will walk on a treadmill at a speed that produces 30-40% of age-adjusted heart rate reserve. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.

Study Details

The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis. This trial involves intense exercise combined with walking on a shaky treadmill. Walking on a shaky treadmill helps to practice balance and intense exercise promotes the ability to walk faster and farther. In this study, participants will train with a combination of high or low intensity, and with a stable or shaky treadmill. Walking speed and endurance, balance while walking and the number of steps taken in the community will be measured before, half way through the training (15 sessions), after training (30 sessions) and six months after training.

Key Dates

Start date
Jan 1, 2023
Status verified
Jun 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: High-Intensity With Pertubations
    30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
  • Experimental: High-Intensity No Perturbations
    30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.
  • Experimental: Moderate-Intensity With Perturbations
    30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
  • Active Comparator: Moderate-Intensity No Perturbations
    30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.

Primary Outcome Measure

Changes in Timed 25-foot walk test [ Time Frame: Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rehabilitation Hospital of IndianaIndianapolisIndiana46254
Thomas G Hornby, PhD
[email protected]
Marquette UniversityMilwaukeeWisconsin53233
Brian D Schmit, PhD
[email protected]
414-288-6125

Find similar trials in Indianapolis, IN

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Rehabilitation Hospital of Indiana· Indianapolis, INMarquette University· Milwaukee, WI

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