Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities

Multiple Sclerosis Clinical Trial

Official title:

Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906737
• Other study ID #: AL0002
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: April 7, 2014
• Start date: April 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: Mount Sinai Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical Diagnosis of MS

• EDSS level between 3.5 - 6.0

• Unilateral foot-drop

• Able to ambulate 25 ft. with no more than a unilateral 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

• Unable to fit safely and properly into the Ankle-Bot device

Related Conditions & MeSH terms

• Congenital Abnormalities
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Ankle-bot
The Ankle-bot is a piece of robotic therapy equipment for the ankle. In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.

Other:
• Conventional focused ankle therapy
Conventional focused ankle therapy will be performed by a physical therapist.

Locations

Country	Name	City	State
United States	Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Parameters		Baseline, throughout study enrollment, and at 1 month and 3 month follow-up