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

MS (Multiple Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872053
• Other study ID #: B4125K-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 27, 2009
• Last updated: September 18, 2013
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• MS (Multiple Sclerosis)
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Anklebot
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
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.

Locations

Country	Name	City	State
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle accuracy and stiffness		At inclusion, after 8 sessions, after 16 sessions
Secondary	Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)		At inclusion, after every 4 sessions
Secondary	Functional assessments (EDSS, MS Functional Composite)		At inclusion, after 8 sessions, after 16 sessions