Vigorous Cool Room Treadmill Training

Memorial University of Newfoundland

Status: Completed

Conditions: Rehabilitation; Gait Disorders, Neurologic; Multiple Sclerosis; Neuronal Plasticity

Treatments: Other: Body-weight supported treadmill training in a room cooled to 16°C

Study type: Interventional

Funder types: Other

Identifiers

NCT04066972

2018.088

Details and patient eligibility

About

People with multiple sclerosis (MS) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. We have developed a cool room treadmill training method that uses body-weight support that people with MS fatigue and heat sensitivity can tolerate. Our previous research shows that people with advanced MS use three times more energy for essential tasks such as walking. This project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking, fitness and fatigue in people with advanced MS.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically definite MS
• relapse-free in the previous 3 months
• requiring ambulatory assistive devices (EDSS 6.0-7.0)
• negative PAR-Q screen for risk factors
• greater than 6-weeks post Botulinum Toxin injection (if received) in the lower extremity

Exclusion criteria

• pregnancy or intention of becoming pregnant
• finished a drug/device study in the last 30 days
• over 75 years of age
• unable to control bowel and bladder on physical exertion
• currently attending physical rehabilitation
• having no difficulty walking in the community (self-selected walking speed >120 cm/s)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single arm

Experimental group

Treatment:

Other: Body-weight supported treadmill training in a room cooled to 16°C