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Clinical Trials/NCT01726998
NCT01726998
Completed
Not Applicable

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

Yonsei University1 site in 1 country72 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Yonsei University
Enrollment
72
Locations
1
Primary Endpoint
change of functional ambulation category point
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

change of functional ambulation category point

Time Frame: 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.

Study Sites (1)

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