VR-treadmill Combined Intervention for Enhancing Mobility and Cognitiv

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

CompletedNot a drug-phase studyRelapsing MSNCT02427997

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Treadmill training with Virtual Reality

Compared with

  • Treadmill training

What it measured

Main measures

  • Immediate change in gait speed

    One week post intervention

    Walking and mobility

  • Number of correct answers in the oral version of the Symbol Digit Modalities Test

    One week post intervention

    Thinking and memory

Other measures (1)

  • The 25 feet walk test (25FWT)

    One week post intervention

    Disability progressionWalking and mobility

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

Inclusion criteria

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.

Exclusion criteria

* 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jun 2015

    2. Main results due

      Mar 2022

    3. Finished

      Mar 2022

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