Gait Training for Persons With Stroke (GTS)

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00612300
First received: January 28, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

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
Stroke
Middle Cerebral Artery Infarction
Behavioral: Lokomat - Physical therapy
Behavioral: Physical therapy - Lokomat
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Six minutes walking test [ Time Frame: Inclusion, wek 3 and week 6 ] [ Designated as safety issue: No ]
  • Gait symmetry index [ Time Frame: Inclusion, week 3 and week 6 ] [ Designated as safety issue: No ]
  • Timed Up And Go [ Time Frame: Inclusion, Week 3 and Week 6 ] [ Designated as safety issue: No ]

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.


  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: John Brincks, PT, PhD student, Hammel Neurorehabilitation and Research Center
ClinicalTrials.gov Identifier: NCT00612300     History of Changes
Other Study ID Numbers: 2
Study First Received: January 28, 2008
Last Updated: February 16, 2010
Health Authority: Denmark: The Ministry of the Interior and Health

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

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

ClinicalTrials.gov processed this record on July 28, 2014