Comparing Mobilization Techniques for the Hemiplegic Shoulder

NCT03211364 | Completed

• 1 other identifier: 2016/0404
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegic Shoulder; Mobility Limitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Spasticity of the shoulder muscles using the Modified Ashworth Scale

  Measuring every 4 weeks up to 12 weeks after admission to the study protocol

• Trunk Impairment Scale to assess trunk stability

  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

  Measuring every 4 weeks up to 12 weeks after admission to the study protocol

Study Arms (3)

Angular mobilization

ACTIVE COMPARATOR

Angular mobilization of the shoulder joint in the frontal plane.

Other: Glenohumeral mobilization

Angular mobilization with soft tissue techniques

ACTIVE COMPARATOR

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

Scapular mobilization

PLACEBO COMPARATOR

Scapular mobilization without glenohumeral movement.

Other: Scapular mobilization

Interventions

Glenohumeral mobilization OTHER

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.

Angular mobilization; Angular mobilization with soft tissue techniques

Scapular mobilization OTHER

Scapular mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First stroke
• Upper limb impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Vakgroep Revaki - Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Cambier, Prof

  University Ghent

  STUDY CHAIR

• Kristine Oostra, Dr

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients do not know what are the intervention techniques or what is the control technique.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: July 7, 2017
• Study Start: May 1, 2016
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

BE (1)