NCT00612300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for early_phase_1 stroke

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

January 28, 2008

Last Update Submit

February 16, 2010

Conditions

StrokeMiddle Cerebral Artery Infarction

Keywords

Ambulatory stroke patientsGait trainingLokomatPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • 10 meters walking test (gait speed)

    at inclusion, week 3 and week 6

Secondary Outcomes (3)

  • 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

Study Arms (2)

A-B

EXPERIMENTAL

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

B-A

EXPERIMENTAL

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

Behavioral: Physical therapy - Lokomat

Interventions

Lokomat - Physical therapyBEHAVIORAL

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

A-B
Physical therapy - LokomatBEHAVIORAL

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.

B-A

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation and Research Center

Hammel, Denmark

Location

MeSH Terms

Conditions

StrokeInfarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral InfarctionBrain InfarctionBrain IschemiaCerebral Arterial DiseasesIntracranial Arterial DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jørgen F Nielsen, Professor

    Hammel Neurorehabilitation and Research Center, Denmark

    STUDY CHAIR

  • Carsten Kock-Jensen, MD

    Hammel Neurorehabilitation and Research Center, Denmark

    STUDY DIRECTOR

  • John Brincks, PhD student

    Hammel Neurorehabilitation and Reseach Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

DK(1)