Clinical trial NCT04768140: Bobath Approach On Hemiplegic Shoulder Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: Hemiplegia
hemiplegic shoulder pain
neurodevelopmental treatment
spasticity
stroke
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks
timeFrame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Secondary outcomes:
measure: Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 6 weeks
timeFrame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
measure: Change from baseline modified Ashworth scale value at 30 sessions, 6 weeks
timeFrame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Other outcomes:
measure: Change from baseline Brunnstrom Motor Recovery Staging value at 30 sessions, 6 weeks
timeFrame: First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
state: Bahçelievler
Study officials:
affiliation: Istanbul Arel University
name: NAZLI GÜNGÖR, PT,MSc
role: PRINCIPAL_INVESTIGATOR
References:
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