Lokomat Treadmill Training Effects on MS Gait

November 9, 2015 updated by: Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06112
        • Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Clinical diagnosis of MS
  • EDSS level between 3.5-6.0
  • Problems with ambulation
  • able to ambulate 25 feet without an assistive device

Main Exclusion Criteria:

  • Lower extremity injuries that limit range of motion or function
  • Unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment

  • Body weight over 150 kg

    • complete inclusion/exclusion criteria listed in consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
The placebo group did not receive treatment during the matched period yet did undergo all assessments. The MS Placebo group received equal treatment following the study intervention period.
Other: Usual Care - no active intervention
No treatment used for comparison
Other Names:
  • control group
Experimental: Combination Treadmill training group
Subjects randomized to Combination therapy received 20 minutes of Lokomat assisted treadmill training followed by up to 20 minutes of BWS treadmill training (without robotic assistance) twice a week.
Other: Body-weight supported treadmill training +/- Lokomat assistance
walking
Other Names:
  • Lokomat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Gait Parameters
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
Baseline, throughout study enrollment and 2 months follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6 minute walk
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
The 6 minute walk test is measured on a treadmill. The subject is asked to indicate the most comfortable treadmill speed to the therapist. The subject is instructed to walk as far as possible in 6 minutes and the total distance covered in 6 minutes is recorded. A harness, without body-weight support, is attached for safety.
Baseline, throughout study enrollment and 2 months follow-up
MSQLI (Multiple Sclerosis Quality of Life Index)
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
The MSQLI is a battery consisting of 10 individual scales providing a quality of life measure that is both generic and MS-specific (Fischer et al, 1999). The MS quality of life index is a validated instrument used in accessing multiple aspects of quality of life for persons with MS. It is a modification of the short-form health survey (SF-36) and requires about 30-45 minutes to complete.
Baseline, throughout study enrollment and 2 months follow-up
Timed 25-foot walk
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
Will be collected over-ground and on a straight 25-foot GaitRite electronic mat. The subject will be timed over the 25-foot distance both at their self-designated usual pace and at the fastest safe pace possible. Data will be collected using a laptop computer. The GaitRite system has software to calculate several measures including velocity, stride length, base width and number of steps.
Baseline, throughout study enrollment and 2 months follow-up
Frequency of Falls
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
Falls will be recorded by the subjects onto a "Falls Calender" provided to the subjects. Subjects will be given the following definition of a fall: "an event which results in a person coming to rest inadvertently on the ground or other lower level, and other than as a consequence of the following: sustaining a violent blow; loss of consciousness; sudden onset of paralysis, as in a stroke and an epileptic seizure" (Vellas 1992).
Baseline, throughout study enrollment and 2 months follow-up
FRT (Functional Reach Test)
Time Frame: Baseline, throughout study enrollment and 2 months follow-up
The Functional Reach test is a measure of balance and is the difference from arm's length and maximal forward reach. The support case is fixed. The test utilizes a 48-inch measuring device or "yardstick" for measuring functional reach. Data is measured in inches (Duncan P. W. et al 1990).
Baseline, throughout study enrollment and 2 months follow-up
CDP (Computerized Dynamic Posturography)
Time Frame: Baseline, throughout study enrollment and 2 months follow-up

NeuroCom Smart Balance Master system. The use of CDP has allowed clinicians to objectively measure the postural components of balance (Liston 1996). CDP assesses sway by measuring shifts in the center of gravity (COG) as a person moves within the available limits of stability (LOS). Two types of tests will be used with CDP; they are the Sensory Organization Test (SOT) and the LOS test.

  1. SOT: measures sway and is designed to quantify an individual's ability to maintain balance in a variety of complex sensory conditions.
  2. LOS: measures volitional control of the COG. Test measures include maximum end-point excursion for anterior, posterior, right, and left movements.
Baseline, throughout study enrollment and 2 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mount Sinai Rehabilitation Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Albert Lo, MD, PhD, Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AL0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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