Comparison of Robot-assisted Gait Training According to Gait Speed in Participants With Stroke

Comparison of the experimental group that applied the speed of the robot-assisted gait training constantly and the control group that applied the gradual increase of the speed of the robot-assisted gait training.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Constant gait speed group; Other: Increasing gait speed group

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • 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
• 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: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Constant gait speed group; experimental group that applied the speed of the robot-assisted gait training constantly	Other: Constant gait speed group; The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.
OTHER: Increasing gait speed group; control group that applied the gradual increase of the speed of the robot-assisted gait training	Other: Increasing gait speed group; The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure (EE)	EE(kcal/min): energy expenditure per minute	2 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure (EE)	EE(kcal/min): energy expenditure per minute	baseline, 1 weeks after baseline, 3 weeks after baseline
Heart rate (HR)	Cardiac frequency	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Volume of Oxygen (VO2)	O2 consumption/1min	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Respiratory Quotient (R)	Respiratory quotient	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Metabolic equivalent (METS)	the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
oxygenated hemoglobin (OxyHb)	oxygenated hemoglobin concentration of cortical activation	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
deoxygenated hemoglobin (DeoxyHb)	deoxygenated hemoglobin concentration of cortical activation	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
Lower extremity 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, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after 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, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after 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, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline
timed up and go test	simple test used to assess a person's mobility and requires both static and dynamic balance	baseline, 1 weeks after baseline, 2 weeks after baseline, 3 weeks after baseline

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (ACTUAL): June 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: stroke; gait speed; Robot-assisted gait training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: NRC-2019-01-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No