NCT05395637

Brief Summary

To explore the reliability of remote Longshi Scale assessment with smartphone video calls by comparing the consistency of remote assessment and bedside assessment, as well as the test-retest reliability of the remote assessment. The evaluation duration of these two methods was recorded and the level of satisfaction of patients and evaluators was investigated.

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
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

5 days

First QC Date

May 25, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

StrokeTele-rehabilitationActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Consistency of the disability degree evaluated using the remote assessment and the bedside assessment of Longshi Scale.

    Weighted kappa(wK) and Bland-Altman were used to determined the consistency between the results of remote assessment method and bedside assessment method. The interpretation of wK scores was in accordance with published standards (values\>0.75 indicating excellent agreement beyond chance; 0.4\~0.75, moderate agreement beyond chance; \<0.4, poor agreement beyond chance).

    Within 24 hours

Secondary Outcomes (3)

  • The test-retest reliability of the remote video assessment

    Within 24 hours after first evaluation

  • Satisfaction survey of remote assessment

    Within 24 hours after the remote assessment

  • Assessment duration

    Within 24 hours

Study Arms (2)

Assessed with the remote assessment of Longshi Scale first and then with bedside assessment

Assessed with the bedside assessment of Longshi Scale first and then with remote assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors from the Department of Rehabilitation Medicine at Shenzhen Second People's Hospital are invited to participate in this study according to the inclusion and exclusion criteria

You may qualify if:

  • a.Stroke survivors
  • aged 18 and above;
  • diagnosed with cerebral infraction or intracerebral hemorrhage;
  • stroke onset2 weeks;
  • stable vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature);
  • voluntary or guardian consent to participate in the study.
  • b.Evaluators
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  • registered rehabilitation practitioner;
  • experience in rehabilitation scientific research or education related work for more than two years

You may not qualify if:

  • a.Stroke survivors
  • brain tumor, Parkinson's disease or active epilepsy within past three months;
  • a history of mental illness such as mania or delirium;
  • participation in any other clinical study. b.Evaluators
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  • unable to finish the training of Longshi Scale or use smartphones proficiently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 27, 2022

Study Start

May 20, 2022

Primary Completion

May 25, 2022

Study Completion

May 30, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations