Gait Training for Persons With Stroke (GTS)

University of Aarhus

Status and phase: Completed; Early Phase 1

Conditions: Middle Cerebral Artery Infarction; Stroke

Treatments: Behavioral: Physical therapy - Lokomat; Behavioral: Lokomat - Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00612300

2

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

A-B

Experimental group

Description:

Gait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist

Treatment:

Behavioral: Lokomat - Physical therapy

B-A

Experimental group

Description:

Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training

Treatment:

Behavioral: Physical therapy - Lokomat