VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
Virtual Reality-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
1 other identifier
interventional
139
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jun 2015
Longer than P75 for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 8, 2022
April 1, 2022
6.8 years
March 15, 2015
April 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immediate change in gait speed
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance
One week post intervention
Number of correct answers in the oral version of the Symbol Digit Modalities Test
The SDMT measures sustained attention and cognitive processing speed, is responsive to change and intervention in MS, can be administered in a relatively short period of time (\< 5 minutes), is largely resistant to practice effects, is valid and reliable in MS, and has been used in many clinical trials in MS. The SDMT involves matching numbers to corresponding symbols for 90 seconds and is a main component of the brief international cognitive assessment for MS (BICAMS). The number of correctly matched symbols is considered the outcome score. This test measures attention and visual spatial processing, and it is likely that the SDMT will change in response to the TT+VR, and not in response to TT. Indeed, SDMT has been associated with cognitive motor interference in patients with MS.
One week post intervention
Secondary Outcomes (1)
The 25 feet walk test (25FWT)
One week post intervention
Study Arms (2)
Treadmill training with virtual reality
EXPERIMENTALThe TT+VR patients (i.e., the experimental arm) will receive 18 sessions (3 times per week x 6 weeks) of training that will consist of walking on a treadmill while wearing a safety harness (without body weight support, recall Figure 1), and while being provided with feedback from the system.
Treadmill training alone
ACTIVE COMPARATORTT alone will receive conventional treadmill training with no feedback from the system. They will train with a safety harness 18 sessions (3 times per week x 6 weeks).
Interventions
VR is defined in general as a "high-end-computer interface that involves real time simulation and interactions through multiple sensorial channels". The VR system to be used requires subjects to negotiate virtual obstacles while walking on a treadmill, in a safe environment. This dual task activity has large cognitive components such as information processing, planning, and attention while allowing for training in a more stimulating and enriching environment that includes both cognitive and motor components.
The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Motor Control Research Lab at the University of Illinois Urbana-Champaign
Urbana, Illinois, 61801, United States
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Related Publications (1)
Galperin I, Mirelman A, Schmitz-Hubsch T, Hsieh KL, Regev K, Karni A, Brozgol M, Cornejo Thumm P, Lynch SG, Paul F, Devos H, Sosnoff J, Hausdorff JM. Treadmill training with virtual reality to enhance gait and cognitive function among people with multiple sclerosis: a randomized controlled trial. J Neurol. 2023 Mar;270(3):1388-1401. doi: 10.1007/s00415-022-11469-1. Epub 2022 Nov 11.
PMID: 36357586DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnon Karni, MD
TASMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2015
First Posted
April 28, 2015
Study Start
June 1, 2015
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
April 8, 2022
Record last verified: 2022-04