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Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke

Primary Purpose

Stroke, Hemiparetic Patients After Subacute Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot-assisted gait therapy
conventional gait training
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hemiparesis as result of 1st stroke
  2. No other neurologic or orthopedic disorder
  3. Independent ambulation before the stroke
  4. No severe medical illnesses
  5. Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups
  6. Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation
  7. The interval between stroke and start of the treatment
  8. Time since stroke onset < 6 months
  9. age: 20-80yrs old

Exclusion Criteria:

  1. Unstable fractures
  2. Severe osteoporosis
  3. Severe skin problems
  4. Severe joint problems
  5. Major difference in leg length,
  6. Body weight over 130 kg,
  7. Orthostatic circulatory problem
  8. Severe cognitive impairment

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lokomat Group

conventional gait training group

Arm Description

Outcomes

Primary Outcome Measures

change of functional ambulation category point
FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2012
Last Updated
February 17, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01726998
Brief Title
Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aimed in this study to investigate the effects of 4 weeks robot-assisted locomotor training on motor recovery of lower extremities and walking ability compared with the conventional gait training in subacute post-stroke non-ambulatory hemiplegic patients. 72 first-ever stroke patients who could not walk independently (FAC < 2), and suffered within 6 months were enrolled and randomly assigned into 2 groups. The subjects with congestive heart failure, malignancies, cardiopulmonary dysfunctions, and who could not walk independently before stroke attack were excluded. Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment (NDT) basically. The robotic assisted locomotor training group received additional robotic-assisted gait therapy for 30minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods. The independent walking ability(FAC ≥ 3), Functional Ambulation Category (FAC), Motricity index (MI), Fugl-Meyer assessment (FMA), Modified Barthel Index (MBI), Medical Research Council (MRC) for each lower extremity muscles were assessed before, during (2weeks) and after training. And the independent walking ability were followed until 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparetic Patients After Subacute Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lokomat Group
Arm Type
Experimental
Arm Title
conventional gait training group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Robot-assisted gait therapy
Intervention Description
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
Intervention Type
Other
Intervention Name(s)
conventional gait training
Intervention Description
Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
Primary Outcome Measure Information:
Title
change of functional ambulation category point
Description
FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.
Time Frame
baseline, during training (2weeks), post training (4weeks) & followed for 2months after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemiparesis as result of 1st stroke No other neurologic or orthopedic disorder Independent ambulation before the stroke No severe medical illnesses Hemiparesis: lower extremity strength graded ≤ 3 in more than 2 muscle groups Functional ambulation classification (FAC) ≤ 1 : indicating a need for personal assistance in ambulation The interval between stroke and start of the treatment Time since stroke onset < 6 months age: 20-80yrs old Exclusion Criteria: Unstable fractures Severe osteoporosis Severe skin problems Severe joint problems Major difference in leg length, Body weight over 130 kg, Orthostatic circulatory problem Severe cognitive impairment
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Locomotion Training With Assistance of a Robot-Driven Gait Orthosis in Hemiparetic Patients After Subacute Stroke

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