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The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Not Applicable
Completed
Conditions
Rehabilitation
Hemiplegia
Interventions
Device: shoulder sling
Device: forearm sling
Registration Number
NCT04830189
Lead Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
shoulder slingsshoulder slingPatients were used shoulder sling in addition to conservative treatment.
forearm slingforearm slingPatients were used forearm sling in addition to conservative treatment.
Primary Outcome Measures
NameTimeMethod
Berg Balance Scale (BBS)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.

Visual analog scale (VAS)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.

Fugl-Meyer Assessment of Motor Recovery after StrokeChange 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.

Barthel IndexChange 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

🇹🇷

Istanbul, Turkey

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