Bobath Approach On Hemiplegic Shoulder Pain

Not Applicable

Completed

• Conditions: Hemiplegic Shoulder Pain
• Interventions: Procedure: Conventional physiotherapy; Procedure: Bobath treatment approach

• Registration Number: NCT04768140
• Lead Sponsor: Istanbul Arel University

Brief Summary

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.

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 Timeline

• Study Start: 2019-08-10
• Primary Completion: 2020-03-17
• Study Completion: 2020-06-12
• Status Verified: 2021-02
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physiotherapy group	Conventional physiotherapy	Only conventional physiotherapy program was applied to this group.
Bobath group	Conventional physiotherapy	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.
Bobath group	Bobath treatment approach	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks	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 Outcome Measures

Name	Time	Method
Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 6 weeks	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
Change from baseline modified Ashworth scale value at 30 sessions, 6 weeks	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

Trial Locations

Locations (1)

University of Health Sciences, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Bahçelievler, Turkey