Multiple SclerosisNCT02427997
VR-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
A study testing Treadmill training with Virtual Reality and Treadmill training in people with Multiple Sclerosis, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Treadmill training with Virtual Reality and Treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Motor Control Research Lab at the University of Illinois Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Virtual Reality-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
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.
Read the detailed description
A prospective, single blinded,randomized controlled trial with 6 month follow-up will be employed to investigate the effects of treadmill training augmented with virtual reality on patients with MS. The study will include 200 participants. Participants will be randomized to either the intervention or active comparator. The intervention group will receive 18 sessions of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will receive 18 training sessions of treadmill training alone (TT) without the VR simulation All interventions will be delivered by therapists trained in the standard protocols. All subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45 minutes.Training progression will be based on increasing both motor and cognitive challenges, individualized to the participant's level of performance.
- Conditions
- Multiple Sclerosis
- Being tested
- Treadmill training with Virtual Reality, Treadmill training
- Keywords
- Virtual Reality, Treadmill, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill training with Virtual RealityBehavioural
Also called TT+VR
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.
Treadmill trainingBehavioural
Also called TT
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.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill training with virtual reality | Experimental | 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. Receives: Behavioral: Treadmill training with Virtual Reality |
| Treadmill training alone | Active comparator | 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). Receives: Behavioral: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: One week post intervention
Secondary outcomes (1)
The 25 feet walk test (25FWT)
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.
Measured: One week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arnon Karni, MD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427997
- Sponsor's protocol ID
- TASMC-15-NG-063-CTIL
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2015
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36357586
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02427997
- Acronym / sponsor ID
- TASMC-15-NG-063-CTIL
- Conditions
- Multiple Sclerosis
- Keywords
- Virtual Reality, Treadmill, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, single blinded,randomized controlled trial with 6 month follow-up will be employed to investigate the effects of treadmill training augmented with virtual reality on patients with MS. The study will include 200 participants. Participants will be randomized to either the intervention or active comparator. The intervention group will receive 18 sessions of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will receive 18 training sessions of treadmill training alone (TT) without the VR simulation All interventions will be delivered by therapists trained in the standard protocols. All subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45 minutes.Training progression will be based on increasing both motor and cognitive challenges, individualized to the participant's level of performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill training with virtual reality | Experimental | Behavioral: Treadmill training with Virtual RealityThe 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 comparator | Behavioral: Treadmill trainingTT 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients will be excluded if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill training with Virtual RealityAlso: TT+VRVR 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. | Behavioural | Treadmill training with virtual reality |
| Treadmill trainingAlso: TTThe 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. | Behavioural | Treadmill training alone |
Primary outcome
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.
1 secondary outcome
The 25 feet walk test (25FWT)
Time frame: One week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 36357586Galperin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Karni, MD principal investigator
TASMC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training with Virtual Reality and Treadmill training in people with Multiple Sclerosis, run by Tel-Aviv Sourasky Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate change in gait speed (time frame: One week post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.