Bobath Approach On Hemiplegic Shoulder Pain (BAHSP)

February 22, 2021 updated by: NAZLI GÜNGÖR, Istanbul Arel University

The Effect Of Bobath Approach On Hemiplegic Shoulder Pain, Spasticity And Upper Extremity Functionality In Stroke Patients: A Prospective, Randomized, Controlled And Single-Blind Trial

In this study, it is investigated that whether Bobath approach is superior to conventional physiotherapy in terms of improving hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: This study aims to determine the effect of Bobath approach on hemiplegic shoulder pain, spasticity and upper extremity functionality in stroke patients.

Patients and Methods: For this prospective, randomized, controlled and single-blind trial, 30 stroke patients aged 40-65 years with hemiplegic shoulder pain were included. Patients were divided into two groups and randomized into these groups. Only conventional physiotherapy was applied to the control group, whereas both conventional physiotherapy and Bobath exercises were also applied to the experimental group. Visual analog scale (horizontal) for shoulder pain, modified Ashworth scale for spasticity and Fugl-Meyer assessment of the upper extremity for functionality were used for both pre-test and post-test.

Study Type

Interventional

Enrollment (Actual)

30

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
    • Bahçelievler
      • Istanbul, Bahçelievler, Turkey, 34186
        • University of Health Sciences, Istanbul Physical Medicine and 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

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 40 and 65
  • Patients who had a stroke for the first time and had a disease duration of at least four weeks
  • Patients who were diagnosed with ischemic or hemorrhagic stroke
  • Patients who had Brunnstrom stage 3, 4 or 5 and had hemiplegic shoulder pain were included in the study.

Exclusion Criteria:

  • Patients with severe cognitive impairment who could not understand simple verbal commands
  • Those who had severe dysarthria to prevent verbal communication
  • Those with unilateral neglect syndrome
  • Those with loss of sensation in the upper extremity of the hemiplegic side
  • Those with botulinum toxin-A injected to the hemiplegic upper extremity muscles
  • Those with previous shoulder-related trauma or pain history
  • Those with other accompanying neurological disease were excluded from the study.

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: Bobath group
A conventional physiotherapy program was applied to this group. Additionally, Bobath treatment approach was applied for 10 repetitions during a 30-min session in the experimental group, in addition to the conventional physiotherapy program.
Procedure: Bobath treatment approach
scapulothoracic mobilization exercise, reaching in different directions in the supine position and upper extremity weight transfer exercise.
Other Names:
  • Neurodevelopmental treatment
Procedure: Conventional physiotherapy
range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.
Active Comparator: Conventional physiotherapy group
Only conventional physiotherapy program was applied to this group.
Procedure: Conventional physiotherapy
range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks
Time Frame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Upper extremity functionality, min-max: 0-66, "0" indicates no function of upper extremity, "66" indicates the highest functionality of upper extremity as possible.
First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 6 weeks
Time Frame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Hemiplegic shoulder pain, 0-10 cm scale, "0" shows no pain at hemiplegic shoulder, "10" shows unbearable pain intensity at hemiplegic shoulder
First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Change from baseline modified Ashworth scale value at 30 sessions, 6 weeks
Time Frame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Upper extremity spasticity, 0: No increase in tone, 1: slight increase in tone giving a catch when slight increase in muscle tone manifested by the limb was moved in flexion or extension.

1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )

2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed

3: considerable increase in tone, passive movement difficult

4: limb rigid in flexion or extension
First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Brunnstrom Motor Recovery Staging value at 30 sessions, 6 weeks
Time Frame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Upper extremity motor evaluation,
First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Collaborators and Investigators

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

Sponsor

Istanbul Arel University

Investigators

  • Principal Investigator: NAZLI GÜNGÖR, PT,MSc, Istanbul Arel University

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)

August 10, 2019

Primary Completion (Actual)

March 17, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAHSP

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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