The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04830189

Collaborator

(none)

Enrollment

Location

Arms

11.7

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Rehabilitation	Device: shoulder sling Device: forearm sling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Jan 20, 2018

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Stroke [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 [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul		Turkey	34192

Sponsors and Collaborators

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04830189

Other Study ID Numbers:

IstPMRTRH-BMR20

First Posted:

Apr 5, 2021

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Additional relevant MeSH terms:

Hemiplegia

Study Results

No Results Posted as of Apr 5, 2021