VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

A prospective, randomized controlled single-blind trial will test the hypotheses that a 6- week intervention that combines treadmill training (TT) with virtual reality (VR) significantly improves real-life, functional mobility and cognitive abilities, keys to health-related quality of life in patients with MS.

Key facts

Study ID

NCT02427997

Run by

Tel-Aviv Sourasky Medical Center

People needed

139

Starts

2015-06-01

Expected to finish

2022-03-31

Last updated by the study team

2022-04-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be included if:
• They are between 18-65 years of age.
• They have a confirmed diagnosis of relapsing remitting MS.
• They have a score between 2 and 6 on the Expanded Disability Status Scale (EDSS)
• They are free from dementia as determined using the Mini Mental State Exam (MMSE>=24)
• They can walk on the treadmill without partial body weight support harness for 5 minutes at their preferred walking speed; this is set as the smallest bout length at the start of training.
• They have no history of epileptic seizures.
• They have no MS exacerbation within the preceding 4 weeks, as determined by interview and medical notes review.
• They have stable MS disease treatments (e.g., last intake of steroids occurred at least 50 days before the enrolment, MS-specific drugs stable from at least 3 months, symptomatic drugs stable from at least 1 month before the enrolment).
• They have adequate hearing (as evaluated by the whisper test and adequate vision capabilities (as measured using a Snellen chart, 6.20 cut-off).
• They are willing to commit to treadmill training program week and participate in all of the assessments.
• They provide informed written consent and are willing to be randomized to any of the 2 study arms.

You may not qualify if…

• Patients will be excluded if:
• They cannot follow safety or training instructions.
• They have another neurological disorder, unstable cardiovascular disease, diabetes, lower limb arthritis, acute lower back or lower extremity pain, peripheral neuropathy, rheumatic or severe orthopaedic problems that may interfere with walking, or have diagnosed psychiatric problems.
• They are pregnant.
• They are undergoing any experimental drug or other kind of therapy.
• Their medication regime is likely to change during the course of the study.
• They are already participating in an intensive exercise program. The use of walking aids will not exclude participation.

Where it is running

• Motor Control Research Lab at the University of Illinois Urbana-Champaign — Urbana, Illinois, United States
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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