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

NCT01726998 | Completed

• 1 other identifier: 4-2012-0005
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparetic Patients After Subacute Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lokomat Group

EXPERIMENTAL

Other: Robot-assisted gait therapy

conventional gait training group

ACTIVE COMPARATOR

Other: conventional gait training

Interventions

Robot-assisted gait therapy OTHER

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.

Lokomat Group

conventional gait training OTHER

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 group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 15, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

KR (1)