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Completed

NCT Number: NCT00612300

Gait Training for Persons With 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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Infarction, Middle Cerebral Artery Intracranial Arterial Diseases Ischemia Middle Cerebral Artery Infarction Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hammel Neurorehabilitation and Research Center

Hammel, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Co-morbidity which impedes study participations
  • Language deficits which makes it impossible to understand oral or written study instructions
  • More than 190 cm tall and 135 kg in weight
  • Pregnancy
  • No gait function prior stroke
  • 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 -

Treatment and study plan

Lokomat - Physical therapy

Behavioral

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

Physical therapy - Lokomat

Behavioral

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 outcomes

  1. 10 meters walking test (gait speed)

    Time frame: at inclusion, week 3 and week 6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: GTS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2008
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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