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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Fawcett, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00906737
First received: May 20, 2009
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Device: Ankle-bot
Other: Conventional focused ankle therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities

Resource links provided by NLM:


Further study details as provided by Mount Sinai Rehabilitation Hospital:

Primary Outcome Measures:
  • Gait Parameters [ Time Frame: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ankle-Bot Training
Subjects in this group receive focused ankle training using the ankle-bot device.
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.
Active Comparator: Conventional Therapy
Subjects in this group will receive conventional focused ankle physical therapy.
Other: Conventional focused ankle therapy
Conventional focused ankle therapy will be performed by a physical therapist.
No Intervention: Control
Subjects in this group will not receive treatment; they will continue their usual care.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906737

Locations
United States, Connecticut
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, United States, 06112
Sponsors and Collaborators
Mount Sinai Rehabilitation Hospital
Investigators
Principal Investigator: Albert Lo, M.D., Ph. D. Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Jennifer Fawcett, Research Manager, Mount Sinai Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT00906737     History of Changes
Other Study ID Numbers: AL0002
Study First Received: May 20, 2009
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai Rehabilitation Hospital:
Multiple Sclerosis
Gait
foot-drop
Ankle-Bot
Physical Therapy
Gait Abnormalities

Additional relevant MeSH terms:
Congenital Abnormalities
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014