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Completed

NCT Number: NCT04768140

Bobath Approach On Hemiplegic Shoulder Pain

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.

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Key information

Conditions

Hemiplegic Shoulder Pain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahçelievler, 34186, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bobath treatment approach

Procedure

scapulothoracic mobilization exercise, reaching in different directions in the supine position and upper extremity weight transfer exercise.

Other names: Neurodevelopmental treatment

Conventional physiotherapy

Procedure

range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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,

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study title

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

Acronym: BAHSP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2021
Registry last updated
Feb 24, 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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