Comparisons of Two Types of Robot Assisted Gait Training

Not Applicable

• Conditions: Robot Assisted Gait Training; Stroke
• Interventions: Device: end-effector type robot; Device: exoskeleton type robot

• Registration Number: NCT03341065
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

Brief Summary

Comparisons of Two Types of Robot Assisted Gait Training: Exoskeleton Type Robot vs. End-effector Type Robot: Randomized Controlled Trial

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-10-22
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-13
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-17
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Hemiplegic patients secondary to first cerebrovascular accidents
• Ankle dorsiflexor strength: medical research council scale 2 or 3
• Functional ambulation category score 3

Exclusion Criteria

• History of surgery of affected lower limb
• Fracture of affected lower limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
end-effector type robot	end-effector type robot	end-effector type robot assisted gait training (G-EO system)
exoskeleton type robot	exoskeleton type robot	exoskeleton type robot assisted gait training (Lokomat orthosis)

Primary Outcome Measures

Name	Time	Method
Change of Range of motion of ankle joint at 4 weeks	4 weeks from baseline	ankle joint motion of sagittal plane during gait

Secondary Outcome Measures

Name	Time	Method
Trunk impairment scale	Baseline, 4 weeks from baseline, 8 weeks from baseline	Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination, and the maximum score on the subscales are 7, 10, and 6 points, repectively. The total score ranges from 0 to 23 points, a higher score indicating a better trunk performance.
Berg Balance Scale	Baseline, 4 weeks from baseline, 8 weeks from baseline	Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life. Each task is scored on a five-point scale (0-4) floolwing the guidelines of the test develpers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
10m walk test	Baseline, 4 weeks from baseline, 8 weeks from baseline	10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
Fugl-Meyer Assessment	Baseline, 4 weeks from baseline, 8 weeks from baseline	Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity. It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
Korean version of Falls efficacy scale	Baseline, 4 weeks from baseline, 8 weeks from baseline	Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
Range of motion of hip joint	Baseline, 4 weeks from baseline, 8 weeks from baseline	Hip joint motion of sagittal plane during gait
Range of motion of knee joint	Baseline, 4 weeks from baseline, 8 weeks from baseline	knee joint motion of sagittal plane during gait
Range of motion of ankle joint	Baseline, 8 weeks from baseline	ankle joint motion of sagittal plane during gait
Electromyography of lower extremities	Baseline, 4 weeks from baseline, 8 weeks from baseline	Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
Plantar pressure	Baseline, 4 weeks from baseline, 8 weeks from baseline	Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
Step length, time	Baseline, 4 weeks from baseline, 8 weeks from baseline	Step length, stance time, swing time, and stride time during gait
Functional Ambulation Category	Baseline, 4 weeks from baseline, 8 weeks from baseline	Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of