Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients (SinSbyS&Co)

Shoulder pain is frequently reported as a complication among stroke patients. Muscular imbalance disrupts stability of the glenohumeral joint creating a subluxation. Stretching the soft tissue can cause shoulder pain which impedes quality of life, length of stay and rehabilitation outcome. To align the humeral head in the cavitas glenoïdalis a shoulder orthosis is often provided to the patient. Since the use of these orthoses is not always considered positive by the patient nor the therapist the question rises if the investigators can objectify if the subacromial space is reduced when wearing a sling.

Sonography is a valid way to asses subluxation of the shoulder joint by measuring the subacromial space. To objectify if an orthosis can reduce the enlarged subacromial space the investigators will use sonography to measure the distance between acromion and greater tuberosity are between acromion and the humeral head. This distance will be measured with and without the orthosis and also after a period of at least 4 hours of wearing the orthosis. This last measurement might inform us about how long the orthosis can correct the glenohumeral position. To validate the sonographic measurement X-rays will be taken by a sample of the investigators study population to compare with the ultrasound data.

Two different orthoses will be compared. First of all the actimove sling, which is standardly used in the rehabilitation centre where patients will be recruited. This sling can be adapted by the patient itself and is very easy to wear. The disadvantage is that the elbow is continuously flexed, which enlarges the risk on contractures of m. biceps and m. brachioradialis. Also the negative influence on the interpretation of the body scheme and on the quantitative use of the arm can be reasons not to wear this kind of orthosis. The shoulderlift on the other hand is a newly developed orthosis which supports the shoulder joint with the arm extended. This is a more normal position during the daily living and stimulates the use of the paretic arm. An extra adaptation can be adjusted to make it possible to position the arm flexed in order to reduce oedema of the hand if necessary. The control group does not wear any orthosis at all.

Additional the investigators will evaluate passive range of motion of the shoulder, spasticity of the upper limb (modified ashworth scale), active motion of the upper limb (fugl meyer assessment) and trunk stability (Trunk Impairment Scale) at starting point and after a period of 6 weeks wearing the orthosis minimal 6 hours a day.

If possible the investigators will do an evaluation of balance on a moving platform and an evaluation of gait with and without the orthosis after 6 weeks to assess the impact of on balance and gait.

Study Overview

• Status: Completed
• Conditions: Stroke Patients
• Intervention / Treatment: Device: actimove sling; Device: shoulderlift

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital, Department of Physical and Rehabilitation Medicine
  • Ghent, Belgium, 9000
    • Ghent University, Department of Rehabilitation Sciences and Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First stroke
• Patients must be able to sit independently on a chair with arm support during 30 minutes

Exclusion Criteria:

• No shoulder problems prior to stroke
• No severe cognitive problems that make it impossible to understand brief commands;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: actimove sling; standard orthosis: actimove sling	Device: actimove sling
Experimental: shoulderlift; newly developed orthosis: shoulderlift	Device: shoulderlift
No Intervention: controle group; no orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acromio - humeral distance	at 9 weeks after admission in the rehabilitation center
Acromio - humeral distance	at 3 weeks after admission in the rehabilitation center

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity	Modified Ashworth Scale	at 9 weeks after admission in the rehabilitation center
Passive Range of motion	goniometric measurement	at 9 weeks after admission in the rehabilitation center
Trunk stability	Trunk Impairment Scale	at 9 weeks after admission in the rehabilitation center
comfort of the upper limb	Pain and comfort questionnaire	at 9 weeks after admission in the rehabilitation center
Balance		at 9 weeks after admission in the rehabilitation center
Gait characteristics	Measurement: Gait Rite	at 9 weeks after admission in the rehabilitation center
Spasticity	Modified Ashworth Scale	at 3 weeks after admission in the rehabilitation center
Passive Range of motion	goniometric measurement	at 3 weeks after admission in the rehabilitation center
Trunk stability	Trunk Impairment Scale	at 3 weeks after admission in the rehabilitation center
comfort of the upper limb	Pain and comfort questionnaire	at 3 weeks after admission in the rehabilitation center
Balance		at 3 weeks after admission in the rehabilitation center
Gait characteristics	Measurement: Gait Rite	at 3 weeks after admission in the rehabilitation center
Pain of the upper limb	Pain and comfort questionnaire	at 3 weeks after admission in the rehabilitation center
Pain of the upper limb	Pain and comfort questionnaire	at 9 weeks after admission in the rehabilitation center

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Dirk Cambier, MD, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: EC/2013/991