NCT04654793

Brief Summary

Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups. Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment. The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group. Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

March 17, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

5.7 years

First QC Date

November 25, 2020

Last Update Submit

December 2, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (15)

  • Fugl-Meyer Assessment (lower)

    A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.

    before intervention

  • Fugl-Meyer Assessment (lower)

    A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.

    4weeks after

  • Fugl-Meyer Assessment (lower)

    A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side.

    8weeks after

  • Motricity Index

    A tool used to evaluate motor power.

    before intervention

  • Motricity Index

    A tool used to evaluate motor power.

    4weeks after

  • Motricity Index

    A tool used to evaluate motor power.

    8weeks after

  • FAC (Functional ambulatory scale)

    A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.

    before intervention

  • FAC (Functional ambulatory scale)

    A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.

    4weeks after

  • FAC (Functional ambulatory scale)

    A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.

    8weeks after

  • Locomotion level of FIM (functional independence measure)

    Indicator to evaluate independence in performing daily life movements

    before intervention

  • Locomotion level of FIM (functional independence measure)

    Indicator to evaluate independence in performing daily life movements

    4weeks after

  • Locomotion level of FIM (functional independence measure)

    Indicator to evaluate independence in performing daily life movements

    8weeks after

  • Berg balance scale

    A tool to evaluate balance

    before intervention

  • Berg balance scale

    A tool to evaluate balance

    4weeks after

  • Berg balance scale

    A tool to evaluate balance

    8weeks after

Study Arms (2)

Intervention group

EXPERIMENTAL

Robot assisted inclined bed treatment and FES

Device: Robot assisted inclined bed treatment and FES

Control group

ACTIVE COMPARATOR

conventional inclined bed treatment

Device: conventional inclined bed treatment

Interventions

Robot assisted inclined bed treatment and FESDEVICE

FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks.

Intervention group
conventional inclined bed treatmentDEVICE

conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week

Control group

Eligibility Criteria

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

You may qualify if:

  • Patients within 4 weeks of onset of first stroke
  • Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
  • Adult male or female over 50 years of age
  • Those who have consented in writing to this clinical trial
  • A person who understands the purpose of the clinical trial and can adapt well to the treatment process

You may not qualify if:

  • Those with lower motor neuron lesions
  • A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
  • Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
  • A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
  • Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
  • Those with the construction of the lower extremities
  • Those with deep vein thrombosis or arterial vascular disease of the lower extremities
  • Pregnant women
  • Not appropriate according to the judgment of other researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Deog Young Kim

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

82-2-2228-3700kimdy@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 4, 2020

Study Start

March 17, 2017

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)