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

This study is currently recruiting participants.
Verified November 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01726998
First received: November 7, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Hemiparetic Patients After Subacute Stroke
 Other: Robot-assisted gait therapy
Other: conventional gait training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • change of functional ambulation category point [ Time Frame: baseline, during training (2weeks), post training (4weeks) & followed for 2months after training ] [ Designated as safety issue: No ]
    FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.


Estimated Enrollment: 36
Study Start Date: March 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat Group Other: Robot-assisted gait therapy
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.
Active Comparator: conventional gait training group Other: conventional gait training
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726998

Contacts
Contact: Deog Young Kim, MD, PhD 82-2-2228-3714 KIMDY@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Deog Young Kim, MD, PhD     82-2228-3714     KIMDY@yuhs.ac    
Principal Investigator: Deog Young Kim, MD, PhD            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01726998     History of Changes
Other Study ID Numbers: 4-2012-0005
Study First Received: November 7, 2012
Last Updated: November 9, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 21, 2013