Clinical trial NCT04830189: The Effectiveness of Two Different Types of Shoulder Slings in Stroke
Official title: Comparison of the Effectiveness of Two Different Types of Slings in Shoulder Subluxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Rehabilitation
Keywords: Stroke
subluxation
shoulder
slings
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Change from Baseline VAS score at 8 weeks
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: Change from Baseline Fugl Meyer test score at 8 weeks
measure: Barthel Index
timeFrame: Change from Baseline Barthel Index score at 8 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline Berg Balance Scale score at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Mustafa Aziz Yıldırım, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.