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Gait Training for Persons With Stroke (GTS)

Primary Purpose

Stroke, Middle Cerebral Artery Infarction

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Lokomat - Physical therapy
Physical therapy - Lokomat
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Ambulatory stroke patients, Gait training, Lokomat, Physical therapy

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • Hammel Neurorehabilitation and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A-B

B-A

Arm Description

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

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

Outcomes

Primary Outcome Measures

10 meters walking test (gait speed)

Secondary Outcome Measures

Six minutes walking test
Gait symmetry index
Timed Up And Go

Full Information

First Posted
January 28, 2008
Last Updated
February 16, 2010
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00612300
Brief Title
Gait Training for Persons With Stroke
Acronym
GTS
Official Title
The Lokomat Gait Orthosis Compared to Categorized Gait Training by Physical Therapists in Patients Early Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Middle Cerebral Artery Infarction
Keywords
Ambulatory stroke patients, Gait training, Lokomat, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A-B
Arm Type
Experimental
Arm Description
Gait training by an automatic gait trainer (Lokomat) for 3 weeks followed by 3 weeks of categorized gait training by a physical therapist
Arm Title
B-A
Arm Type
Experimental
Arm Description
Categorized gait training by physical therapists for 3 weeks followed by 3 weeks of lokomat training
Intervention Type
Behavioral
Intervention Name(s)
Lokomat - Physical therapy
Intervention Description
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
Intervention Name(s)
Physical therapy - Lokomat
Intervention Description
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.
Primary Outcome Measure Information:
Title
10 meters walking test (gait speed)
Time Frame
at inclusion, week 3 and week 6
Secondary Outcome Measure Information:
Title
Six minutes walking test
Time Frame
Inclusion, wek 3 and week 6
Title
Gait symmetry index
Time Frame
Inclusion, week 3 and week 6
Title
Timed Up And Go
Time Frame
Inclusion, Week 3 and Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen F Nielsen, Professor
Organizational Affiliation
Hammel Neurorehabilitation and Research Center, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carsten Kock-Jensen, MD
Organizational Affiliation
Hammel Neurorehabilitation and Research Center, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Brincks, PhD student
Organizational Affiliation
Hammel Neurorehabilitation and Reseach Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation and Research Center
City
Hammel
Country
Denmark

12. IPD Sharing Statement

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Gait Training for Persons With Stroke

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