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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726998
• Other study ID #: 4-2012-0005
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: February 17, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hemiparetic Patients After Subacute Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of functional ambulation category point	FAC is a functional walking test that evaluates ambulation ability. This is an 6-point scale.	baseline, during training (2weeks), post training (4weeks) & followed for 2months after training	No