Lokomat Treadmill Training Effects on MS Gait

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Gait, Unsteady
• Interventions: Other: Usual Care - no active intervention; Other: Body-weight supported treadmill training +/- Lokomat assistance

• Registration Number: NCT00835835
• Lead Sponsor: Mount Sinai Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2011-10
• Study Completion: 2013-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Usual Care - no active intervention	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.
Combination Treadmill training group	Body-weight supported treadmill training +/- Lokomat assistance	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.

Primary Outcome Measures

Name	Time	Method
Gait Parameters	Baseline, throughout study enrollment and 2 months follow-up

Trial Locations

Locations (1)

Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital; 🇺🇸 Hartford, Connecticut, United States