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

NCT02102269 | Completed

• 1 other identifier: EC/2013/991
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke Patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Spasticity

  at 9 weeks after admission in the rehabilitation center

• Passive Range of motion

  at 9 weeks after admission in the rehabilitation center

• Trunk stability

  at 9 weeks after admission in the rehabilitation center

• comfort of the upper limb

  at 9 weeks after admission in the rehabilitation center

• Balance

  at 9 weeks after admission in the rehabilitation center

Study Arms (3)

actimove sling

ACTIVE COMPARATOR

standard orthosis: actimove sling

Device: actimove sling

shoulderlift

EXPERIMENTAL

newly developed orthosis: shoulderlift

Device: shoulderlift

controle group

NO INTERVENTION

no orthosis

Interventions

actimove sling DEVICE

actimove sling

shoulderlift DEVICE

shoulderlift

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University Hospital, Department of Physical and Rehabilitation Medicine

Ghent, 9000, Belgium

Location

Ghent University, Department of Rehabilitation Sciences and Physiotherapy

Ghent, 9000, Belgium

Location

Study Officials

• Dirk Cambier, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: April 2, 2014
• Study Start: January 1, 2014
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (2)