Comparisons of Two Types of Robot Assisted Gait Training

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03341065
• Other study ID #: NRC-2016-01-006
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2017
• Last updated: November 13, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Robot Assisted Gait Training
• Stroke

Intervention

Device:
• exoskeleton type robot

• end-effector type robot

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Range of motion of ankle joint at 4 weeks	ankle joint motion of sagittal plane during gait	4 weeks from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Range of motion of hip joint	Hip joint motion of sagittal plane during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	Range of motion of knee joint	knee joint motion of sagittal plane during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	Range of motion of ankle joint	ankle joint motion of sagittal plane during gait	Baseline, 8 weeks from baseline
Secondary	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
Secondary	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
Secondary	Step length, time	Step length, stance time, swing time, and stride time during gait	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	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

External Links

•   Site of the present study