Gait Training for Persons With Stroke (GTS)

February 16, 2010 updated by: University of Aarhus

The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke

The objective of this study is to investigate the effects of an automatic gait trainer (Lokomat) handled by physical therapists compared with categorized gait training by physical therapists in ambulatory stroke patients. Gait speed, gait distance and gait symmetry are used to evaluate study effects.

Hypotheses: 1) The Lokomat improves stroke patients gait speed, distance and symmetry more than categorized gait training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark
        • Hammel Neurorehabilitation and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. First time Stroke
  2. Middle cerebral artery infarction
  3. Less than three month from stroke onset
  4. Able to walk with or without a stick at gait speed less than 0.5 m/s
  5. Participants are able to cope with the Lokomat

Exclusion Criteria:

  1. Co-morbidity which impedes study participations
  2. Language deficits which makes it impossible to understand oral or written study instructions
  3. More than 190 cm tall and 135 kg in weight
  4. Pregnancy
  5. No gait function prior stroke
  6. Skin sore or eruption on lower extremity or trunk, differences in lower extremity length of more than 2 cm or contracture of lower extremity which impedes gait training in the Lokomat -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-B
Gait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist
Behavioral: Lokomat - Physical therapy
A: Lokomat training, 30 minutes per day for 3 weeks, 5 days per week. B: Categorized gait training by physical therapist, 30 minutes per day for 3 weeks, 5 days per week
Experimental: B-A
Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training
Behavioral: Physical therapy - Lokomat

B: Daily 30 minutes of gait training with a physical therapist, 5 days per week for 3 weeks.

A: Daily 30 minutes of Lokomat training, 5 days per week for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
10 meters walking test (gait speed)
Time Frame: at inclusion, week 3 and week 6
at inclusion, week 3 and week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Six minutes walking test
Time Frame: Inclusion, wek 3 and week 6
Inclusion, wek 3 and week 6
Gait symmetry index
Time Frame: Inclusion, week 3 and week 6
Inclusion, week 3 and week 6
Timed Up And Go
Time Frame: Inclusion, Week 3 and Week 6
Inclusion, Week 3 and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Jørgen F Nielsen, Professor, Hammel Neurorehabilitation and Research Center, Denmark
  • Study Director: Carsten Kock-Jensen, MD, Hammel Neurorehabilitation and Research Center, Denmark
  • Principal Investigator: John Brincks, PhD student, Hammel Neurorehabilitation and Reseach Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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