Gait Training for Persons With Stroke

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Middle Cerebral Artery Infarction

Intervention / Treatment
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* Behavioral: Lokomat - Physical therapy
* Behavioral: Physical therapy - Lokomat


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-B<br>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<br>* 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<br>|
| Experimental: B-A<br>Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training | Behavioral: Physical therapy - Lokomat<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory stroke patients, Gait training, Lokomat, Physical therapy