Lokomat Treadmill Training Effects on MS Gait

NCT ID: NCT00835835

Last Updated: 2015-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gait, Unsteady Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Usual Care - no active intervention

Intervention Type OTHER

No treatment used for comparison

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.

Group Type EXPERIMENTAL

Body-weight supported treadmill training +/- Lokomat assistance

Intervention Type OTHER

walking

Interventions

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Body-weight supported treadmill training +/- Lokomat assistance

walking

Intervention Type OTHER

Usual Care - no active intervention

No treatment used for comparison

Intervention Type OTHER

Other Intervention Names

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Lokomat control group

Eligibility Criteria

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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

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Ruiz, DPT

Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Lo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

Locations

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Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital

Hartford, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10467384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1591453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2229941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8629916 (View on PubMed)

Related Links

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http://www.saintfrancisdoctors.com/ms

Mandell Center for Multiple Sclerosis home page

Other Identifiers

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AL0001

Identifier Type: -

Identifier Source: org_study_id

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