NCT04581551

Brief Summary

This study aims

  1. 1.To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.
  2. 2.To assess if differentiation can be made between the hemiplegic (HP) and non-hemiplegic (NHP) side and between stroke patients and matched healthy volunteers (discriminative validity).
  3. 3.To assess if an immediate effect on the pectoralis major and minor can be measured after applying transversal stretch technique to the pectoralis major muscles (response validity).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

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

September 9, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

December 14, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

September 9, 2020

Last Update Submit

December 13, 2022

Conditions

Stroke

Keywords

StrokeShear wave elastographyShoulder musclesShoulder pain

Outcome Measures

Primary Outcomes (12)

  • SWV m. supraspinatus

    Shear wave velocity of the m. supraspinatus

    Single point of assessment on day 1 (test)

  • SWV m. supraspinatus

    Shear wave velocity of the m. supraspinatus

    Single point of assessment on day 2 (retest)

  • SWV m. infraspinatus

    Shear wave velocity of the m. infraspinatus

    Single point of assessment on day 1 (test)

  • SWV m. infraspinatus

    Shear wave velocity of the m. infraspinatus

    Single point of assessment on day 2 (retest)

  • SWV m. rhomboideus major

    Shear wave velocity of the m. rhomboideus major

    Single point of assessment on day 1 (test)

  • SWV m. rhomboideus major

    Shear wave velocity of the m. rhomboideus major

    Single point of assessment on day 2 (retest)

  • SWV m. deltoideus

    Shear wave velocity of the m. deltoideus

    Single point of assessment on day 1 (test)

  • SWV m. deltoideus

    Shear wave velocity of the m. deltoideus

    Single point of assessment on day 2 (retest)

  • SWV m. pectoralis major

    Shear wave velocity of the m. pectoralis major

    Single point of assessment on day 1 (test)

  • SWV m. pectoralis major

    Shear wave velocity of the m. pectoralis major

    Single point of assessment on day 2 (retest)

  • SWV m. pectoralis minor

    Shear wave velocity of the m. pectoralis minor

    Single point of assessment on day 1 (test)

  • SWV m. pectoralis minor

    Shear wave velocity of the m. pectoralis minor

    Single point of assessment on day 2 (retest)

Secondary Outcomes (7)

  • Demographic variables

    Baseline assessment day 1

  • Passive range of motion of shoulder

    Baseline assessment day 1

  • Spasticity shoulder muscles

    Assessment day 1

  • Shoulder subluxation - ultrasound measurement

    Assessment day 1

  • Fugl-Meyer assessment upper limb section

    Assessment day 1

  • +2 more secondary outcomes

Other Outcomes (1)

  • Subcutaneous tissue thickness

    Single point of assessment on day 1

Study Arms (2)

Stroke group

EXPERIMENTAL

SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

Procedure: SWE assessor 1Procedure: SWE assessor 2Procedure: Stretch interventionProcedure: No stretch intervention

Healthy controls

ACTIVE COMPARATOR

SWE for 6 shoulder muscles will be performed by 1 assessors. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

Procedure: SWE assessor 1

Interventions

SWE assessor 1PROCEDURE

SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

Healthy controlsStroke group
SWE assessor 2PROCEDURE

SWE for 6 shoulder muscles will be performed. * m. supraspinatus * m. infraspinatus * m. rhomboideus major * m. deltoideus * m. pectoralis major * m. pectoralis minor

Stroke group
Stretch interventionPROCEDURE

Transversal stretch of pectoralis major muscle on the hemiplegic side.

Stroke group
No stretch interventionPROCEDURE

Passive mobilisation of the hemiplegic hand.

Stroke group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke patients in the subacute phase after stroke (\< 6 months post stroke)
  • Able to sit independently with support of the back, but without support of the arms
  • With upper-limb (UL) impairment: i.e. no maximum score (36) on the shoulder elbow part of the Fugl-Meyer UL (FM UL)

You may not qualify if:

  • Other neurologic disorders
  • Shoulder or neck surgery before stroke onset
  • Arthroscopic surgery in the last year before stroke onset.
  • Shoulder or neck pain in the last year before stroke onset.
  • Severe cognitive or language deficits that inhibit the participants of understanding simple commands or providing valuable information regarding the outcome measures - measured with the Ability Q.
  • Participants who are not able to maintain the test position.
  • Pregnancy
  • Healthy controls can participate if they
  • Have not suffered a stroke or other neurological disorders
  • Did not have surgery at the shoulder and/or neck
  • Did not have arthroscopic surgery in the last year before stroke
  • If they do not suffer any shoulder or neck pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

StrokeShoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Annelies Maenhout, Prof

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Kristine Oostra, Prof

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Dirk Cambier, Prof

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 9, 2020

Study Start

October 5, 2020

Primary Completion

September 27, 2021

Study Completion

September 27, 2021

Last Updated

December 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)