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Gait Training for Persons With Stroke (GTS)

This study has been completed.
Information provided by:
University of Aarhus Identifier:
First received: January 28, 2008
Last updated: February 16, 2010
Last verified: February 2010

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.

Condition Intervention Phase
Middle Cerebral Artery Infarction
Behavioral: Lokomat - Physical therapy
Behavioral: Physical therapy - Lokomat
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 10 meters walking test (gait speed) [ Time Frame: at inclusion, week 3 and week 6 ]

Secondary Outcome Measures:
  • Six minutes walking test [ Time Frame: Inclusion, wek 3 and week 6 ]
  • Gait symmetry index [ Time Frame: Inclusion, week 3 and week 6 ]
  • Timed Up And Go [ Time Frame: Inclusion, Week 3 and Week 6 ]

Estimated Enrollment: 16
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -
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Please refer to this study by its identifier: NCT00612300

Hammel Neurorehabilitation and Research Center
Hammel, Denmark
Sponsors and Collaborators
University of Aarhus
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
  More Information

Responsible Party: John Brincks, PT, PhD student, Hammel Neurorehabilitation and Research Center Identifier: NCT00612300     History of Changes
Other Study ID Numbers: 2
Study First Received: January 28, 2008
Last Updated: February 16, 2010

Keywords provided by University of Aarhus:
Ambulatory stroke patients
Gait training
Physical therapy

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebral Infarction
Brain Infarction
Brain Ischemia
Intracranial Arterial Diseases processed this record on May 25, 2017