Lokomat Treadmill Training Effects on MS Gait

Mount Sinai Rehabilitation Hospital

Status: Completed

Conditions: Gait, Unsteady; Multiple Sclerosis

Treatments: Other: Usual Care - no active intervention; Other: Body-weight supported treadmill training +/- Lokomat assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT00835835

AL0001

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Usual Care - no active intervention

Combination Treadmill training group

Experimental group

Description:

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.

Treatment:

Other: Body-weight supported treadmill training +/- Lokomat assistance