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Gait Training for Persons With Stroke (GTS)

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ClinicalTrials.gov Identifier: NCT00612300
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
Stroke Middle Cerebral Artery Infarction Behavioral: Lokomat - Physical therapy Behavioral: Physical therapy - Lokomat Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke
Study Start Date : June 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.





Primary Outcome Measures :
  1. 10 meters walking test (gait speed) [ Time Frame: at inclusion, week 3 and week 6 ]

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


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

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612300


Locations
Denmark
Hammel Neurorehabilitation and Research Center
Hammel, Denmark
Sponsors and Collaborators
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

Responsible Party: John Brincks, PT, PhD student, Hammel Neurorehabilitation and Research Center
ClinicalTrials.gov Identifier: NCT00612300     History of Changes
Other Study ID Numbers: 2
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Stroke
Infarction
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases