The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03767205
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing

1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

Condition or Disease	Intervention/Treatment	Phase
Stroke; Gait, Hemiplegic	Device: Ankle Assist Robot	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients
• Actual Study Start Date: Dec 17, 2018
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: stroke patients All participants perform overground walking and treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot).

Device: Ankle Assist Robot; overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).

Outcome Measures

Primary Outcome Measures

1. Change on gait speed in different three conditions [20minutes]

   All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.

Secondary Outcome Measures

1. Change on gait function in different three conditions (kinematic) [20minutes]

   All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinematic using a motion analysis.

2. Change on gait function in different three conditions (kinetic) [20minutes]

   All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of kinetic using a force plate.

3. Change on gait function in different three conditions (muscle activation) [20minutes]

   All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of muscle activation using a surface EMG.

4. Change on metabolic energy expenditure in different three conditions [1 hour]

   All participants perform treadmill walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stroke patients with hemiplegia over 19 years old

• Ischemic or hemorrhagic stroke patients over 3 months of onset

• Functional Ambulation Category Scale with 3 or more scales

Exclusion Criteria:

• Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures

• Stroke patients with walking difficulty due to serious cognitive problems

• Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot

• Stroke patients at risk of falling when walking with severe dizziness

• Modified ashworth scale (MAS) Stroke patients over 3

• Pregnant woman

• People with mental illness and psychiatric medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: YunHee Kim, Kim, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03767205
• Other Study ID Numbers: 2018-06-128
• First Posted: Dec 6, 2018
• Last Update Posted: Dec 9, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Samsung Medical Center: gait function; Metabolic energy expenditure; ankle assist robot
• Additional relevant MeSH terms: Stroke; Gait Disorders, Neurologic

Study Results

No Results Posted as of Dec 9, 2019