NCT02843828

Brief Summary

The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

July 14, 2016

Last Update Submit

April 8, 2019

Conditions

StrokeHealthy

Keywords

Exoskeleton Deviceelderlystrokegait rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in 10 meter walk test from baseline in gait speed

    Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

    session 0 (initial visit); session 11 (at approximately 4 weeks)

Secondary Outcomes (9)

  • Berg Balance Scale (BBS)

    session 0 (initial visit); session 11 (at approximately 4 weeks)

  • Tinetti performance oriented mobility assessment (POMA)

    session 0 (initial visit); session 11 (at approximately 4 weeks)

  • Modified Bathel index (MBI)

    session 0 (initial visit); session 11 (at approximately 4 weeks)

  • Modified Rankin Scale (MRS)

    session 0 (initial visit); session 11 (at approximately 4 weeks)

  • Functional Ambulation Classification (FAC)

    session 0 (initial visit); session 11 (at approximately 4 weeks)

  • +4 more secondary outcomes

Study Arms (2)

Samsung Hip Assist v1

EXPERIMENTAL

gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Device: gait rehabilitation with Samsung Hip Assist v1

Conventional gait training

ACTIVE COMPARATOR

gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Other: gait rehabilitation without Samsung Hip Assist v1

Interventions

gait rehabilitation with Samsung Hip Assist v1DEVICE

Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

Samsung Hip Assist v1
gait rehabilitation without Samsung Hip Assist v1OTHER

Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

Conventional gait training

Eligibility Criteria

Age50 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly adults
  • Age: between 65 and 84 years
  • elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
  • Ability to walk at least 10m regardless of assist devices
  • High levels of physical performance (SPPB \> 7)
  • Subject is willing to be randomized to the control group or the treatment group
  • Stroke
  • Age: between 50 and 84 years
  • ≥ 3 months post stroke
  • Ability to walk at least 10m regardless of assist devices
  • Adequate gait function (FAC \> 3)
  • Physician approval for patient participation
  • Subject is willing to be randomized to the control group or the treatment group

You may not qualify if:

  • Elderly adults
  • History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
  • Severe visual impairment or dizziness that increases the risk of falls
  • Stroke
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Advanced liver, kidney, cardiac, or pulmonary disease
  • History of concussion in last 6 months
  • History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
  • Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • Lee HJ, Lee SH, Seo K, Lee M, Chang WH, Choi BO, Ryu GH, Kim YH. Training for Walking Efficiency With a Wearable Hip-Assist Robot in Patients With Stroke: A Pilot Randomized Controlled Trial. Stroke. 2019 Dec;50(12):3545-3552. doi: 10.1161/STROKEAHA.119.025950. Epub 2019 Oct 18.

    PMID: 31623545DERIVED

  • Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.

    PMID: 29183379DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 26, 2016

Study Start

January 2, 2016

Primary Completion

August 30, 2017

Study Completion

September 1, 2017

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)