The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Rehabilitation Clinical Trial

Official title:

Comparison of the Effectiveness of Two Different Types of Slings in Shoulder Subluxation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830189
• Other study ID #: IstPMRTRH-BMR20
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: April 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2019
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hemiplegia
• Rehabilitation

Intervention

Device:
• shoulder sling
Patients were used shoulder slings
• forearm sling
Patients were used forearm slings

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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;(1):CD003863. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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 — View 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. Erratum in: Phys Ther 1988 Dec;68(12):1969. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)	Pain assessment was performed with Visual Analog Scale after 8-weeks after treatment. Using a ruler, the score is determined by measuring the distance (mm) on the 100-mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	Change from Baseline VAS score at 8 weeks
Primary	Fugl-Meyer Assessment of Motor Recovery after Stroke	Sensorimotor evaluation was performed with Fugl-Meyer Assessment of Motor Recovery after Stroke. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.	Change from Baseline Fugl Meyer test score at 8 weeks
Primary	Barthel Index	Daily life activities were assessed with Barthel Index. The minimum score is 0, which indicates complete dependency and, the maximum score is 100 indicates complete independence.	Change from Baseline Barthel Index score at 8 weeks
Primary	Berg Balance Scale (BBS)	Balance was evaluated with Berg Balance Scale. The minimum score is 0 and, the maximum score is 56. 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance.	Change from Baseline Berg Balance Scale score at 8 weeks