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

Not Applicable

Completed

• Conditions: Stroke; Hemiparetic Patients After Subacute Stroke
• Interventions: Other: Robot-assisted gait therapy; Other: conventional gait training

• Registration Number: NCT01726998
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-15
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lokomat Group	Robot-assisted gait therapy	-
conventional gait training group	conventional gait training	-

Primary Outcome Measures

Name	Time	Method
change of functional ambulation category point	baseline, during training (2weeks), post training (4weeks) & followed for 2months after training	FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of