Gait Training for Persons With Stroke

NCT ID: NCT00612300

Last Updated: 2010-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

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.

Detailed Description

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Conditions

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Stroke Middle Cerebral Artery Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A-B

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

Group Type EXPERIMENTAL

Lokomat - Physical therapy

Intervention Type 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

B-A

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

Group Type EXPERIMENTAL

Physical therapy - Lokomat

Intervention Type 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.

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Hammel Neurorehabilitation and Research Center

Principal Investigators

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Jørgen F Nielsen, Professor

Role: STUDY_CHAIR

Hammel Neurorehabilitation and Research Center, Denmark

Carsten Kock-Jensen, MD

Role: STUDY_DIRECTOR

Hammel Neurorehabilitation and Research Center, Denmark

John Brincks, PhD student

Role: PRINCIPAL_INVESTIGATOR

Hammel Neurorehabilitation and Reseach Center

Locations

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Hammel Neurorehabilitation and Research Center

Hammel, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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