The Effectiveness of Two Different Types of Shoulder Slings in Stroke

NCT ID: NCT04830189

Last Updated: 2021-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-01-01

Brief Summary

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The aim of this study is to investigate the effectiveness of shoulder slings on pain, motor function, daily life and balance in acute hemiplegic patients and to investigate whether different types of slings are superior to each other.

Detailed Description

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Thirty-two patients with hemiplegic shoulder subluxation due to acute stroke were divided into two groups: shoulder supported slings and forearm supported slings. Hemiplegia rehabilitation passive and active-assistive range of motion, stretching, and neurophysiologic exercises were performed for all patients per day for 8 weeks.Pain assessment was performed with Visual Analog Scale, sensorimotor evaluation was performed with Fugl Meyer Assessment of Motor Function,daily life activities were assessed with Barthel Index, and balance was evaluated with Berg Balance Scale.

Conditions

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Hemiplegia Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were assigned to two groups, shoulder supported slings (group 1, n = 20) and forearm supported slings (group 2, n = 20), by an investigator who was blinded to the study via randomization created by a computer software. Evaluation of the detailed physical examination results, evaluation of demographic features such as age, gender, and etiology as well as evaluation of treatment results were performed by the physiatrist who was blind to randomization.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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shoulder slings

Patients were used shoulder sling in addition to conservative treatment.

Group Type EXPERIMENTAL

shoulder sling

Intervention Type DEVICE

Patients were used shoulder slings

forearm sling

Patients were used forearm sling in addition to conservative treatment.

Group Type ACTIVE_COMPARATOR

forearm sling

Intervention Type DEVICE

Patients were used forearm slings

Interventions

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shoulder sling

Patients were used shoulder slings

Intervention Type DEVICE

forearm sling

Patients were used forearm slings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Acute patients who were independent and ambulatory prior to stroke and had their first stroke attack (\<3 months)
* Mini-mental Status Test (MMST) score ≥ 24,
* Developing hemiplegia after stroke, standing independently for at least 2 minutes,
* Lower limb being in stage 4-5 according to the Brunnstrom Approach (for ambulation and standard balance)
* Upper limb being in stage 1-2 according to the Brunnstrom Approach
* Spasticity 0-1+ according to Modified Ashworth scale

Exclusion Criteria

* Has a neurological history other than the diagnosis of hemiplegia (Parkinson's etc.)
* Having used shoulder slings and orthosis.
* Having a disease that can affect balance (cranial, etc.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mustafa Aziz Yıldırım, Assoc prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.

Reference Type RESULT
PMID: 21430513 (View on PubMed)

Zorowitz RD. Recovery patterns of shoulder subluxation after stroke: a six-month follow-up study. Top Stroke Rehabil. 2001 Summer;8(2):1-9. doi: 10.1310/LADU-8LJY-KTQ0-L5DJ.

Reference Type RESULT
PMID: 14523741 (View on PubMed)

Brooke MM, de Lateur BJ, Diana-Rigby GC, Questad KA. Shoulder subluxation in hemiplegia: effects of three different supports. Arch Phys Med Rehabil. 1991 Jul;72(8):582-6.

Reference Type RESULT
PMID: 2059138 (View on PubMed)

Williams R, Taffs L, Minuk T. Evaluation of two support methods for the subluxated shoulder of hemiplegic patients. Phys Ther. 1988 Aug;68(8):1209-14.

Reference Type RESULT
PMID: 3399517 (View on PubMed)

Turner-Stokes L, Jackson D. Assessment of shoulder pain in hemiplegia: sensitivity of the ShoulderQ. Disabil Rehabil. 2006 Mar 30;28(6):389-95. doi: 10.1080/09638280500287692.

Reference Type RESULT
PMID: 16492635 (View on PubMed)

Nadler M, Pauls M. Shoulder orthoses for the prevention and reduction of hemiplegic shoulder pain and subluxation: systematic review. Clin Rehabil. 2017 Apr;31(4):444-453. doi: 10.1177/0269215516648753. Epub 2016 Jul 10.

Reference Type RESULT
PMID: 27184582 (View on PubMed)

Ada L, Foongchomcheay A, Canning C. Supportive devices for preventing and treating subluxation of the shoulder after stroke. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003863. doi: 10.1002/14651858.CD003863.pub2.

Reference Type RESULT
PMID: 15674917 (View on PubMed)

van Bladel A, Lambrecht G, Oostra KM, Vanderstraeten G, Cambier D. A randomized controlled trial on the immediate and long-term effects of arm slings on shoulder subluxation in stroke patients. Eur J Phys Rehabil Med. 2017 Jun;53(3):400-409. doi: 10.23736/S1973-9087.17.04368-4. Epub 2017 Jan 30.

Reference Type RESULT
PMID: 28145396 (View on PubMed)

Other Identifiers

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IstPMRTRH-BMR20

Identifier Type: -

Identifier Source: org_study_id

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