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Targeted Lower Extremity Joint Training

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Anklebot

Lokomat

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, Rehabilitation, Treadmill, Robot, Foot-drop

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Providence VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Anklebot

Body-weight supported treadmill training

Combination therapy (Anklebot and BWSTT)

Outcomes

Primary Outcome Measures

Strength and Gait

Secondary Outcome Measures

Full Information

NCT ID

NCT00765544

First Posted

October 2, 2008

Last Updated

September 19, 2013

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00765544

Brief Title

Targeted Lower Extremity Joint Training

Official Title

Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Terminated

Why Stopped

Study re-design

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The presence of foot drop limits normal gait. Our prior data has suggested that approximately 30% of MS patients have foot drop. Although we 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. We plan to test whether subject foot drop and overall gait benefit more from Anklebot therapy alone or a combination of Anklebot and Lokomat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

MS, Rehabilitation, Treadmill, Robot, Foot-drop

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Anklebot

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Body-weight supported treadmill training

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

Combination therapy (Anklebot and BWSTT)

Intervention Type

Device

Intervention Name(s)

Anklebot

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Lokomat

Intervention Description

The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill .

Primary Outcome Measure Information:

Title

Strength and Gait

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert Lo, MD PhD

Organizational Affiliation

Providence VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence VA Medical Center

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908-4799

Country

United States

12. IPD Sharing Statement

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Targeted Lower Extremity Joint Training

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