Gait Training for Persons With Stroke

Stroke Clinical Trial

— GTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612300
• Other study ID #: 2
• Status: Completed
• Phase: Phase 0
• First received: January 28, 2008
• Last updated: February 16, 2010
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: February 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery
• Middle Cerebral Artery Infarction
• Stroke

Intervention

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
• 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.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation and Research Center	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 meters walking test (gait speed)		at inclusion, week 3 and week 6	No
Secondary	Six minutes walking test		Inclusion, wek 3 and week 6	No
Secondary	Gait symmetry index		Inclusion, week 3 and week 6	No
Secondary	Timed Up And Go		Inclusion, Week 3 and Week 6	No