Targeted Lower Extremity Joint Training

This study has been terminated.
(Study re-design)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00765544
First received: October 2, 2008
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Device: Anklebot
Device: Lokomat
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-assisted Ankle Rehabilitation for Multiple Sclerosis (Anklebot)

Resource links provided by NLM:


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
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 .

  Eligibility

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

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.
  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
Investigators
Principal Investigator: Albert Lo, MD PhD Providence VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00765544     History of Changes
Other Study ID Numbers: LO-0002
Study First Received: October 2, 2008
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
MS
Rehabilitation
Treadmill
Robot
Foot-drop

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014