NCT00835835

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

3.7 years

First QC Date

February 3, 2009

Last Update Submit

November 9, 2015

Conditions

Gait, UnsteadyMultiple Sclerosis

Keywords

Multiple Sclerosisgaitfallslokomatbody-weight support treadmill training

Outcome Measures

Primary Outcomes (1)

  • Gait Parameters

    Baseline, throughout study enrollment and 2 months follow-up

Other Outcomes (6)

  • 6 minute walk

    Baseline, throughout study enrollment and 2 months follow-up

  • MSQLI (Multiple Sclerosis Quality of Life Index)

    Baseline, throughout study enrollment and 2 months follow-up

  • Timed 25-foot walk

    Baseline, throughout study enrollment and 2 months follow-up

  • +3 more other outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Combination Treadmill training group

EXPERIMENTAL

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

Interventions

Body-weight supported treadmill training +/- Lokomat assistanceOTHER

walking

Also known as: Lokomat
Combination Treadmill training group
Usual Care - no active interventionOTHER

No treatment used for comparison

Also known as: control group
Control group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Location

Related Publications (4)

  • Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in multiple sclerosis (MS). Mult Scler. 1999 Aug;5(4):251-9. doi: 10.1177/135245859900500410.

    PMID: 10467384BACKGROUND

  • Vellas B, Baumgartner RN, Wayne SJ, Conceicao J, Lafont C, Albarede JL, Garry PJ. Relationship between malnutrition and falls in the elderly. Nutrition. 1992 Mar-Apr;8(2):105-8.

    PMID: 1591453BACKGROUND

  • Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

    PMID: 2229941BACKGROUND

  • Liston RA, Brouwer BJ. Reliability and validity of measures obtained from stroke patients using the Balance Master. Arch Phys Med Rehabil. 1996 May;77(5):425-30. doi: 10.1016/s0003-9993(96)90028-3.

    PMID: 8629916BACKGROUND

Related Links

MeSH Terms

Conditions

Gait Disorders, NeurologicMultiple Sclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Albert Lo, MD, PhD

    Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

February 1, 2008

Primary Completion

October 1, 2011

Study Completion

June 1, 2013

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

US(1)