NCT04054700

Brief Summary

Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients

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
68

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2019

Typical duration 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

First Submitted

Initial submission to the registry

August 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

August 12, 2019

Last Update Submit

September 8, 2021

Conditions

Keywords

upper limb rehabilitationstrokeproximal upper rehabilitation robotdistal upper rehabilitation robot

Outcome Measures

Primary Outcomes (2)

  • Wolf motor function test

    an activity indicator, has 15 items for testing functional ability

    change from baseline at 4 weeks

  • Fugl-Meyer Assessment

    indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment

    change from baseline at 4 weeks

Secondary Outcomes (11)

  • Fugl-Meyer Assessment

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Motor activity log

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Action reach arm test

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Motor status score

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Box and block test

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • +6 more secondary outcomes

Study Arms (2)

distal upper rehabilitation robot

EXPERIMENTAL

experimental group that applied the distal upper rehabilitation robot

Device: distal upper rehabilitation robot

proximal upper rehabilitation robot

OTHER

control group that applied the proximal upper rehabilitation robot

Device: proximal upper rehabilitation robot

Interventions

Intervention with distal upper rehabilitation robot

distal upper rehabilitation robot

Intervention with proximal upper rehabilitation robot

proximal upper rehabilitation robot

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Onset ≥ 3 months
  • ≤ Fugl-Meyer Assessment score
  • Cognitively intact enough to understand and follow the instructions from the investigator

You may not qualify if:

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 13, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations