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

NCT ID: NCT00906737

Last Updated: 2014-04-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ankle-Bot Training

Subjects in this group receive focused ankle training using the ankle-bot device.

Group Type EXPERIMENTAL

Ankle-bot

Intervention Type DEVICE

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.

Conventional Therapy

Subjects in this group will receive conventional focused ankle physical therapy.

Group Type ACTIVE_COMPARATOR

Conventional focused ankle therapy

Intervention Type OTHER

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

Control

Subjects in this group will not receive treatment; they will continue their usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Conventional focused ankle therapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mount Sinai Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jennifer Fawcett

Research Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Albert Lo, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.saintfrancisdoctors.com/ms/

Mandell Center for Multiple Sclerosis home page

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AL0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lokomat Training Effects on MS Gait Abnormalities
NCT00766272 TERMINATED PHASE1/PHASE2