NCT03243318

Brief Summary

Stroke is the third common cause of adult disability in dveloped countries. Early identification of the potential for motor recovery is important to avoid 'learned disuse' and to initiate appropriate therapy with achievable goals. The current cohort study focuses on those patients with SAFE \<8 and using motor evoked potentials (MEPs) to improve on prognostication of upper limb motor recovery among subacute stroke patients in a local stroke population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

August 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

4.1 years

First QC Date

August 4, 2017

Last Update Submit

May 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test

    Upper limb functional test

    Change of Baseline Action Research Arm Test at 12 weeks post-stroke

Study Arms (2)

Presence of motor evoked potentials

Those patients with Shoulder Abduction and Finger Extension (SAFE) score \<8/10 with the presence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex

Diagnostic Test: MEPs induced by TMS

absence of motor evoked potentials

Those patients with Shoulder Abduction and Finger Extension (SAFE) score \<8/10 with the absence of motor evoked potentials elicited by TMS over the ipsilesional motor cortex

Diagnostic Test: MEPs induced by TMS

Interventions

MEPs induced by TMSDIAGNOSTIC_TEST

Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials

Presence of motor evoked potentialsabsence of motor evoked potentials

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subacute stroke patients

You may qualify if:

  • First stroke with hemiparesis or hemiplegia with SAFE \<8

You may not qualify if:

  • contra-indication to TMS or MRI, history of seizure, pregnancy and mentally unfit to understand the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Kowloon Hospital

Hong Kong, Hong Kong

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 9, 2017

Study Start

October 11, 2017

Primary Completion

October 31, 2021

Study Completion

November 30, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations