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Completed

NCT Number: NCT04830189

The Effectiveness of Two Different Types of Shoulder Slings in Stroke

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.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Shoulder Sling

Device

Patients were used shoulder slings

forearm sling

Device

Patients were used forearm slings

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 5, 2021
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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