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

NCT01726998 · Yonsei University · Updated 19 Feb 2014

What is being tested
Robot-assisted gait therapy; conventional gait training
For
Stroke; Hemiparetic Patients After Subacute Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 20 years to 80 years. About 72 people. The full rules are on the registry page.
Where
South Korea
When
Starts or started March 2012, ends May 2013. Registered 15 Nov 2012.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT01726998

Sites

  • Severance hospitalSeoul, Seoul, South Korea