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Completed

NCT Number: NCT00872053

Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

The primary aim of this study is to:

1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop; 2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.

Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.

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Key information

Conditions

MS (Multiple Sclerosis) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mononeuropathies Multiple Sclerosis Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peroneal Neuropathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Providence VA Medical Center

Providence, Rhode Island, 02908-4799, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Pregnancy (self-reported)
  • PI's determination of inability to complete the test protocol

Treatment and study plan

Anklebot

Device

The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.

Lokomat

Device

The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.

Primary outcomes

  1. Ankle accuracy and stiffness

    Time frame: At inclusion, after 8 sessions, after 16 sessions

Secondary outcomes

  1. Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)

    Time frame: At inclusion, after every 4 sessions

  2. Functional assessments (EDSS, MS Functional Composite)

    Time frame: At inclusion, after 8 sessions, after 16 sessions

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 31, 2009
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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