Skip to main content
Clinical Trials/NCT04830189
NCT04830189
Completed
Not Applicable

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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 site in 1 country32 target enrollmentJanuary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Enrollment
32
Locations
1
Primary Endpoint
Berg Balance Scale (BBS)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2018
End Date
January 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible Party
Sponsor

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.)

Outcomes

Primary Outcomes

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.

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.

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.

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.

Study Sites (1)

Loading locations...

Similar Trials