VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT02427997|
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Treadmill training with Virtual Reality Behavioral: Treadmill training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Virtual Reality-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Treadmill training with virtual reality
The 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.
Behavioral: Treadmill training with Virtual Reality
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.
Other Name: TT+VR
Active Comparator: Treadmill training alone
TT 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).
Behavioral: Treadmill training
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.
Other Name: TT
- Immediate change in gait speed [ Time Frame: One week post intervention ]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
- Number of correct answers in the oral version of the Symbol Digit Modalities Test [ Time Frame: One week post intervention ]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.
- The 25 feet walk test (25FWT) [ Time Frame: One week post intervention ]The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427997
|Contact: Anat Mirelman, PhDfirstname.lastname@example.org|
|United States, Illinois|
|Motor Control Research Lab at the University of Illinois Urbana-Champaign||Recruiting|
|Urbana, Illinois, United States, 61801|
|Contact: Emily Pike 217-244-7006 StopFallsMS@illinois.edu|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel, 6423906|
|Contact: Shirley Shema, MSPT +972-3-6947514 email@example.com|
|Contact: Marina Brozgol, MSc +972-3-6947513 firstname.lastname@example.org|
|Principal Investigator:||Arnon Karni, MD||TASMC|