Targeted Lower Extremity Joint Training

Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Anklebot; Device: Lokomat

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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.
Experimental: Arm 2; 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 .
Experimental: Arm 3; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Strength and Gait	6 months

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (Estimate): October 3, 2008

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Rehabilitation; MS; Robot; Treadmill; Foot-drop
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: LO-0002