The Effectiveness of Two Different Types of Shoulder Slings in Stroke

April 1, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34192
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: shoulder slings
Patients were used shoulder sling in addition to conservative treatment.
Device: shoulder sling
Patients were used shoulder slings
Active Comparator: forearm sling
Patients were used forearm sling in addition to conservative treatment.
Device: forearm sling
Patients were used forearm slings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: Change from Baseline VAS score at 8 weeks
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
Time Frame: Change from Baseline Fugl Meyer test score at 8 weeks
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
Time Frame: Change from Baseline Barthel Index score at 8 weeks
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)
Time Frame: Change from Baseline Berg Balance Scale score at 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Mustafa Aziz Yıldırım, Assoc prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 1, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPMRTRH-BMR20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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