Gait Training for Persons With Stroke

Early Phase 1

Completed

• Conditions: Stroke; Middle Cerebral Artery Infarction
• Interventions: Behavioral: Lokomat - Physical therapy; Behavioral: Physical therapy - Lokomat

• Registration Number: NCT00612300
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-02-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A-B	Lokomat - Physical therapy	Gait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist
B-A	Physical therapy - Lokomat	Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training

Primary Outcome Measures

Name	Time	Method
10 meters walking test (gait speed)	at inclusion, week 3 and week 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hammel Neurorehabilitation and Research Center; 🇩🇰 Hammel, Denmark