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

Yonsei University

Status: Completed

Conditions: Stroke; Hemiparetic Patients After Subacute Stroke

Treatments: Other: conventional gait training; Other: Robot-assisted gait therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01726998

4-2012-0005

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Lokomat Group

Experimental group

Treatment:

Other: Robot-assisted gait therapy

conventional gait training group

Active Comparator group

Treatment:

Other: conventional gait training