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The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Primary Purpose

Hemiplegia, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
shoulder sling
forearm sling
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Stroke, subluxation, shoulder, slings

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

shoulder slings

forearm sling

Arm Description

Patients were used shoulder sling in addition to conservative treatment.

Patients were used forearm sling in addition to conservative treatment.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
April 1, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04830189
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Rehabilitation
Keywords
Stroke, subluxation, shoulder, slings

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shoulder slings
Arm Type
Experimental
Arm Description
Patients were used shoulder sling in addition to conservative treatment.
Arm Title
forearm sling
Arm Type
Active Comparator
Arm Description
Patients were used forearm sling in addition to conservative treatment.
Intervention Type
Device
Intervention Name(s)
shoulder sling
Intervention Description
Patients were used shoulder slings
Intervention Type
Device
Intervention Name(s)
forearm sling
Intervention Description
Patients were used forearm slings
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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.
Time Frame
Change from Baseline VAS score at 8 weeks
Title
Fugl-Meyer Assessment of Motor Recovery after Stroke
Description
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.
Time Frame
Change from Baseline Fugl Meyer test score at 8 weeks
Title
Barthel Index
Description
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.
Time Frame
Change from Baseline Barthel Index score at 8 weeks
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Change from Baseline Berg Balance Scale score at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Aziz Yıldırım, Assoc prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34192
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21430513
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.
Results Reference
result
PubMed Identifier
14523741
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.
Results Reference
result
PubMed Identifier
2059138
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.
Results Reference
result
PubMed Identifier
3399517
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.
Results Reference
result
PubMed Identifier
16492635
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.
Results Reference
result
PubMed Identifier
27184582
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.
Results Reference
result
PubMed Identifier
15674917
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.
Results Reference
result
PubMed Identifier
28145396
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.
Results Reference
result

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The Effectiveness of Two Different Types of Shoulder Slings in Stroke

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