Targeted Lower Extremity Joint Training

NCT00765544 | Terminated Phase 1 DMC

• 1 other identifier: LO-0002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

MS; Rehabilitation; Treadmill; Robot; Foot-drop

Outcome Measures

Primary Outcomes (1)

• Strength and Gait

  6 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Anklebot

Device: Anklebot

Arm 2

EXPERIMENTAL

Body-weight supported treadmill training

Device: Lokomat

Arm 3

EXPERIMENTAL

Combination therapy (Anklebot and BWSTT)

Device: Anklebot; Device: Lokomat

Interventions

Anklebot DEVICE

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.

Arm 1; Arm 3

Lokomat DEVICE

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

Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Providence VA Medical Center

Providence, Rhode Island, 02908-4799, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Albert Lo, MD PhD

  Providence VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (1)