The Effectiveness of Two Different Types of Shoulder Slings in Stroke

NCT04830189 | Completed

• 1 other identifier: IstPMRTRH-BMR20
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Rehabilitation

Keywords

Stroke; subluxation; shoulder; slings

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

shoulder slings

EXPERIMENTAL

Patients were used shoulder sling in addition to conservative treatment.

Device: shoulder sling

forearm sling

ACTIVE COMPARATOR

Patients were used forearm sling in addition to conservative treatment.

Device: forearm sling

Interventions

shoulder sling DEVICE

Patients were used shoulder slings

shoulder slings

forearm sling DEVICE

Patients were used forearm slings

forearm sling

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 21430513 RESULT

• 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.

  PMID: 14523741 RESULT

• 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.

  PMID: 2059138 RESULT

• 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.

  PMID: 3399517 RESULT

• 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.

  PMID: 16492635 RESULT

• 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.

  PMID: 27184582 RESULT

• 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.

  PMID: 15674917 RESULT

• 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.

  PMID: 28145396 RESULT

MeSH Terms

Conditions

Hemiplegia; Stroke; Joint Dislocations

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Mustafa Aziz Yıldırım, Assoc prof

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: January 10, 2018
• Primary Completion: January 20, 2018
• Study Completion: January 1, 2019
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)