Comparing Mobilization Techniques for the Hemiplegic Shoulder

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by University Ghent

Sponsor:

Information provided by (Responsible Party):

University Ghent

ClinicalTrials.gov Identifier:

NCT03211364

First received: June 13, 2017

Last updated: July 4, 2017

Last verified: July 2017

History of Changes

Purpose

One of the main complications after stroke is hemiplegic shoulder pain. It is known that one of the most frequent causes of hemiplegic shoulder pain is a restricted range of motion in the shoulder joint. Therefore, it is neccessary that the passive range of motion is preserved by using the best mobilization technique. The aim of this study is to compare 2 different techniques in order to document their influence on shoulder range of motion and shoulder pain in stroke patients.

Condition	Intervention
Hemiplegic Shoulder Mobility Limitation	Other: Glenohumeral mobilization Other: Scapular mobilization


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant Masking Description: Patients do not know what are the intervention techniques or what is the control technique. Primary Purpose: Treatment
Official Title:	Comparing Mobilization Techniques for the Hemiplegic Shoulder

Further study details as provided by University Ghent:

Primary Outcome Measures:

Range of motion of the shoulder using goniometry [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
Range of motion of the shoulder joint is measured using a goniometer
Shoulder pain using visual analogue scale [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
Shoulder pain during rest, night and activities by using visual analogue scale (0-10)

Secondary Outcome Measures:

Spasticity of the shoulder muscles using the Modified Ashworth Scale [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
Spasticity of upper limb muscles related to the shoulder using Modified Ashworth Scale
Trunk Impairment Scale to assess trunk stability [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
Trunk stability using the Trunk Impairment Scale
Fugl-Meyer Assessment - upper limb part to assess voluntary muscle activity [ Time Frame: Measuring every 4 weeks up to 12 weeks after admission to the study protocol ]
voluntary muscle activity upper limb using the upper limb part of the Fugl-Meyer Scale


Estimated Enrollment:	15
Actual Study Start Date:	May 1, 2016
Estimated Study Completion Date:	December 1, 2018
Estimated Primary Completion Date:	January 1, 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Angular mobilization Angular mobilization of the shoulder joint in the frontal plane.	Other: Glenohumeral mobilization Comparing the effect of angular mobilization in frontal or scapular plane and of providing soft tissue techniques on hemiplegic shoulder range of motion and pain.
Active Comparator: Angular mobilization with soft tissue techniques Angular mobilization in the scapular plane. Additional soft tissue techniques or used to eliminate limitation by hypertensed muscles in order to perform capsular stretch.	Other: Glenohumeral mobilization Comparing the effect of angular mobilization in frontal or scapular plane and of providing soft tissue techniques on hemiplegic shoulder range of motion and pain.
Placebo Comparator: Scapular mobilization Scapular mobilization without glenohumeral movement.	Other: Scapular mobilization

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First stroke
Upper limb impairment

Exclusion Criteria:

Shoulder pain on the hemiplegic side with onset before the stroke
Surgery at the hemiplegic shoulder
Active movement possible within the whole range of motion

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211364

Contacts


Contact: Anke Van Bladel	93324657	anke.vanbladel@ugent.be

Locations


Belgium
Vakgroep Revaki - Ghent University	Recruiting
Ghent, Belgium, 9000
Contact: Anke Van Bladel 93324657 anke.vanbladel@ugent.be
Contact: Dirk Cambier dirk.cambier@ugent.be

Sponsors and Collaborators

University Ghent

Investigators


Study Chair:	Dirk Cambier, Prof	University Ghent
Principal Investigator:	Kristine Oostra, Dr	University Hospital, Ghent

More Information


Responsible Party:	University Ghent
ClinicalTrials.gov Identifier:	NCT03211364 History of Changes
Other Study ID Numbers:	2016/0404
Study First Received:	June 13, 2017
Last Updated:	July 4, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Mobility Limitation Signs and Symptoms

ClinicalTrials.gov processed this record on July 11, 2017

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