Targeted Lower Extremity Joint Training - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00765544

Purpose

The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although the investigators have observed that "task-specific" rehabilitation using the Lokomat can improve ambulation in chronic MS patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance.

One of the key limitations of the Lokomat is a lack of robot-assisted training for the ankle joint. The Anklebot, an MIT-developed rehabilitation robot for the ankle, has the potential to address this. The device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the Anklebot alone does not train the knee or hip.

The investigators plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.

Condition	Intervention	Phase
Multiple Sclerosis	Device: Anklebot Device: Lokomat	Phase I Phase II

MedlinePlus related topics: Foot Health Multiple Sclerosis Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment
Official Title:	Robot-Assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Strength and Gait [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	September 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Anklebot	Device: Anklebot The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion.
2: Experimental Body-weight supported treadmill training	Device: Lokomat The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .
3: Experimental Combination therapy (Anklebot and BWSTT)	Device: Anklebot The Ankle-Bot (Wheeler et al., 2004) is a stand-alone robot assisted device that is worn via a leather boot and knee brace (Fig.1). The Ankle-Bot can assist ankle movement throughout 3 planes. The percentage of force generated by the Ankle-Bot can be adjusted from no help, 0% assistance to 100% assistance. The device is low impedance and a subject can easily over come the forces generated by the Ankle-Bot. The Ankle-Bot will guide and assist the subject into ankle flexion, extension, inversion and eversion. Device: Lokomat The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
Men and women between the ages 18-75 years.
Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
Must be able to ambulate 25 feet without an assisting device.

Exclusion Criteria:

Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg, History of uncontrolled diabetes.
Symptoms of orthostasis when standing up.
Circulatory problems, history of vascular claudication or pitting edema.
Unable to fully understand instructions in order to use the equipment or the process of the study.
Body weight over 150 kg.
Lower extremity injuries that limit range of motion or function.
Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
Unstable fractures.
Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
Chronic and ongoing alcohol or drug abuse.
Pre-morbid, ongoing depression or psychosis.
Ongoing physical therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765544

Locations

United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Albert Lo, MD PhD

Providence VA Medical Center

More Information

Responsible Party:	Department of Veterans Affairs ( Lo, Albert - Principal Investigator )
Study ID Numbers:	LO-0002
Study First Received:	October 2, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00765544
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

MS
Rehabilitation
Treadmill
Robot
Foot-drop

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009