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Completed

NCT Number: NCT02102269

Sonographic Evaluation of the Effect of Shoulder Orthosis on the Subluxation in Stroke Patients

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Department of Physical and Rehabilitation Medicine, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

actimove sling

Device

shoulderlift

Device

Primary outcomes

  1. Acromio - humeral distance

    Time frame: at 9 weeks after admission in the rehabilitation center

  2. Acromio - humeral distance

    Time frame: at 3 weeks after admission in the rehabilitation center

Secondary outcomes

  1. Spasticity

    Time frame: at 9 weeks after admission in the rehabilitation center

    Modified Ashworth Scale

  2. Passive Range of motion

    Time frame: at 9 weeks after admission in the rehabilitation center

    goniometric measurement

  3. Trunk stability

    Time frame: at 9 weeks after admission in the rehabilitation center

    Trunk Impairment Scale

  4. comfort of the upper limb

    Time frame: at 9 weeks after admission in the rehabilitation center

    Pain and comfort questionnaire

  5. Balance

    Time frame: at 9 weeks after admission in the rehabilitation center

  6. Gait characteristics

    Time frame: at 9 weeks after admission in the rehabilitation center

    Measurement: Gait Rite

  7. Spasticity

    Time frame: at 3 weeks after admission in the rehabilitation center

    Modified Ashworth Scale

  8. Passive Range of motion

    Time frame: at 3 weeks after admission in the rehabilitation center

    goniometric measurement

  9. Trunk stability

    Time frame: at 3 weeks after admission in the rehabilitation center

    Trunk Impairment Scale

  10. comfort of the upper limb

    Time frame: at 3 weeks after admission in the rehabilitation center

    Pain and comfort questionnaire

  11. Balance

    Time frame: at 3 weeks after admission in the rehabilitation center

  12. Gait characteristics

    Time frame: at 3 weeks after admission in the rehabilitation center

    Measurement: Gait Rite

  13. Pain of the upper limb

    Time frame: at 3 weeks after admission in the rehabilitation center

    Pain and comfort questionnaire

  14. Pain of the upper limb

    Time frame: at 9 weeks after admission in the rehabilitation center

    Pain and comfort questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: SinSbyS&Co

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2014
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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