NCT02425332

Brief Summary

The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

1.5 years

First QC Date

April 20, 2015

Last Update Submit

December 18, 2017

Conditions

Keywords

Spinal Cord Injuryadaptive controlassessmentassist-as-neededwalking abilityLokomat

Outcome Measures

Primary Outcomes (1)

  • Intraclass Correlation Coefficient between Lokomat score.

    Reliability of Lokomat assessment

    up to one week

Study Arms (1)

Lokomat assessment

EXPERIMENTAL
Device: Lokomat gait trainer

Interventions

Lokomat assessment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals \>1 year post Spinal Cord Injury or able bodied persons

You may not qualify if:

  • presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Balgrist

Zurich, Switzerland

Location

Related Publications (1)

  • Maggioni S, Lunenburger L, Riener R, Curt A, Bolliger M, Melendez-Calderon A. Assessing walking ability using a robotic gait trainer: opportunities and limitations of assist-as-needed control in spinal cord injury. J Neuroeng Rehabil. 2023 Sep 21;20(1):121. doi: 10.1186/s12984-023-01226-4.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations