Comparisons of Two Types of Robot Assisted Gait Training

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

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Robot Assisted Gait Training
• Intervention / Treatment: Device: exoskeleton type robot; Device: end-effector type robot

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • Recruiting
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: exoskeleton type robot; exoskeleton type robot assisted gait training (Lokomat orthosis)	Device: exoskeleton type robot
EXPERIMENTAL: end-effector type robot; end-effector type robot assisted gait training (G-EO system)	Device: end-effector type robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Range of motion of ankle joint at 4 weeks	ankle joint motion of sagittal plane during gait	4 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk impairment scale	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.	Baseline, 4 weeks from baseline, 8 weeks from baseline
Berg Balance Scale	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.	Baseline, 4 weeks from baseline, 8 weeks from baseline
10m walk test	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.	Baseline, 4 weeks from baseline, 8 weeks from baseline
Fugl-Meyer Assessment	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.	Baseline, 4 weeks from baseline, 8 weeks from baseline
Korean version of Falls efficacy scale	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	Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of hip joint	Hip joint motion of sagittal plane during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of knee joint	knee joint motion of sagittal plane during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Range of motion of ankle joint	ankle joint motion of sagittal plane during gait	Baseline, 8 weeks from baseline
Electromyography of lower extremities	Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.	Baseline, 4 weeks from baseline, 8 weeks from baseline
Plantar pressure	Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Step length, time	Step length, stance time, swing time, and stride time during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Functional Ambulation Category	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	Baseline, 4 weeks from baseline, 8 weeks from baseline

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Publications and helpful links

Helpful Links

• Site of the present study

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: October 22, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (ACTUAL): November 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NRC-2016-01-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO