Comparing Mobilization Techniques for the Hemiplegic Shoulder

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 necessary to preserve the passive range of motion by using the most optimal 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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation; Hemiplegic Shoulder
• Intervention / Treatment: Other: Scapular mobilization; Other: Glenohumeral mobilization

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Vakgroep Revaki - Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 performed in the scapular plane. Additional soft tissue techniques to eliminate limitations created by tensed 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Study Chair: Dirk Cambier, Prof, University Ghent; Principal Investigator: Kristine Oostra, Dr, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): November 7, 2017
• Study Completion (ACTUAL): November 7, 2017

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 2016/0404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No