NCT00872053

Brief Summary

The primary aim of this study is to:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

March 27, 2009

Last Update Submit

September 18, 2013

Conditions

MS (Multiple Sclerosis)

Keywords

robottreadmillfoot droprehabilitationgait

Outcome Measures

Primary Outcomes (1)

  • Ankle accuracy and stiffness

    At inclusion, after 8 sessions, after 16 sessions

Secondary Outcomes (2)

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

    At inclusion, after every 4 sessions

  • Functional assessments (EDSS, MS Functional Composite)

    At inclusion, after 8 sessions, after 16 sessions

Study Arms (2)

Arm 1

EXPERIMENTAL

Focused Ankle Training

Device: Anklebot

Arm 2

EXPERIMENTAL

Combination Therapy

Device: AnklebotDevice: Lokomat

Interventions

AnklebotDEVICE

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.

Arm 1Arm 2
LokomatDEVICE

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.

Arm 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • 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.
  • Pregnancy (self-reported)
  • PI's determination of inability to complete the test protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VA Medical Center

Providence, Rhode Island, 02908-4799, United States

Location

MeSH Terms

Conditions

Multiple SclerosisPeroneal Neuropathies

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular 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

March 27, 2009

First Posted

March 31, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

US(1)