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Bobath Approach On Hemiplegic Shoulder Pain (BAHSP)

Primary Purpose

Hemiplegic Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bobath treatment approach

Conventional physiotherapy

About this trial

This is an interventional treatment trial for Hemiplegic Shoulder Pain focused on measuring Hemiplegia, hemiplegic shoulder pain, neurodevelopmental treatment, spasticity, stroke

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bobath group

Conventional physiotherapy group

Arm Description

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.

Only conventional physiotherapy program was applied to this group.

Outcomes

Primary Outcome Measures

Change from baseline Fugl-Meyer Assessment score at 30 sessions, 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

Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 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

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

Full Information

NCT ID

NCT04768140

First Posted

February 19, 2021

Last Updated

February 22, 2021

Sponsor

Istanbul Arel University

1. Study Identification

Unique Protocol Identification Number

NCT04768140

Brief Title

Bobath Approach On Hemiplegic Shoulder Pain

Acronym

BAHSP

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 10, 2019 (Actual)

Primary Completion Date

March 17, 2020 (Actual)

Study Completion Date

June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Arel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegic Shoulder Pain

Keywords

Hemiplegia, hemiplegic shoulder pain, neurodevelopmental treatment, spasticity, stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL

Masking

Participant

Masking Description

SINGLE-BLIND TRIAL The patients were blinded to their group allocation.

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bobath group

Arm Type

Experimental

Arm Description

Arm Title

Conventional physiotherapy group

Arm Type

Active Comparator

Arm Description

Only conventional physiotherapy program was applied to this group.

Intervention Type

Procedure

Intervention Name(s)

Bobath treatment approach

Other Intervention Name(s)

Neurodevelopmental treatment

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional physiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline Fugl-Meyer Assessment score at 30 sessions, 6 weeks

Description

Upper extremity functionality, min-max: 0-66, "0" indicates no function of upper extremity, "66" indicates the highest functionality of upper extremity as possible.

Time Frame

First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Secondary Outcome Measure Information:

Title

Change from baseline Visual Analog Scale (horizontal) value at 30 sessions, 6 weeks

Description

Hemiplegic shoulder pain, 0-10 cm scale, "0" shows no pain at hemiplegic shoulder, "10" shows unbearable pain intensity at hemiplegic shoulder

Time Frame

First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Title

Change from baseline modified Ashworth scale value at 30 sessions, 6 weeks

Description

Time Frame

First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

Other Pre-specified Outcome Measures:

Title

Change from baseline Brunnstrom Motor Recovery Staging value at 30 sessions, 6 weeks

Description

Upper extremity motor evaluation,

Time Frame

First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

NAZLI GÜNGÖR, PT,MSc

Organizational Affiliation

Istanbul Arel University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Istanbul

State/Province

Bahçelievler

ZIP/Postal Code

34186

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22257503

Citation

Huseyinsinoglu BE, Ozdincler AR, Krespi Y. Bobath Concept versus constraint-induced movement therapy to improve arm functional recovery in stroke patients: a randomized controlled trial. Clin Rehabil. 2012 Aug;26(8):705-15. doi: 10.1177/0269215511431903. Epub 2012 Jan 18.

Results Reference

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PubMed Identifier

16180951

Citation

Tang QP, Yang QD, Wu YH, Wang GQ, Huang ZL, Liu ZJ, Huang XS, Zhou L, Yang PM, Fan ZY. Effects of problem-oriented willed-movement therapy on motor abilities for people with poststroke cognitive deficits. Phys Ther. 2005 Oct;85(10):1020-33.

Results Reference

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PubMed Identifier

10945420

Citation

Langhammer B, Stanghelle JK. Bobath or motor relearning programme? A comparison of two different approaches of physiotherapy in stroke rehabilitation: a randomized controlled study. Clin Rehabil. 2000 Aug;14(4):361-9. doi: 10.1191/0269215500cr338oa.

Results Reference

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PubMed Identifier

15822545

Citation

Suputtitada A, Suwanwela NC, Tumvitee S. Effectiveness of constraint-induced movement therapy in chronic stroke patients. J Med Assoc Thai. 2004 Dec;87(12):1482-90.

Results Reference

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PubMed Identifier

16250190

Citation

Platz T, Eickhof C, van Kaick S, Engel U, Pinkowski C, Kalok S, Pause M. Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial. Clin Rehabil. 2005 Oct;19(7):714-24. doi: 10.1191/0269215505cr904oa.

Results Reference

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PubMed Identifier

17896054

Citation

Hafsteinsdottir TB, Kappelle J, Grypdonck MH, Algra A. Effects of Bobath-based therapy on depression, shoulder pain and health-related quality of life in patients after stroke. J Rehabil Med. 2007 Oct;39(8):627-32. doi: 10.2340/16501977-0097.

Results Reference

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PubMed Identifier

17724559

Citation

Fazekas G, Horvath M, Troznai T, Toth A. Robot-mediated upper limb physiotherapy for patients with spastic hemiparesis: a preliminary study. J Rehabil Med. 2007 Sep;39(7):580-2. doi: 10.2340/16501977-0087.

Results Reference

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PubMed Identifier

15774435

Citation

van Vliet PM, Lincoln NB, Foxall A. Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):503-8. doi: 10.1136/jnnp.2004.040436.

Results Reference

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PubMed Identifier

10548673

Citation

van der Lee JH, Wagenaar RC, Lankhorst GJ, Vogelaar TW, Deville WL, Bouter LM. Forced use of the upper extremity in chronic stroke patients: results from a single-blind randomized clinical trial. Stroke. 1999 Nov;30(11):2369-75. doi: 10.1161/01.str.30.11.2369.

Results Reference

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PubMed Identifier

22668675

Citation

Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.

Results Reference

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PubMed Identifier

15759530

Citation

Wang RY, Chen HI, Chen CY, Yang YR. Efficacy of Bobath versus orthopaedic approach on impairment and function at different motor recovery stages after stroke: a randomized controlled study. Clin Rehabil. 2005 Mar;19(2):155-64. doi: 10.1191/0269215505cr850oa.

Results Reference

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Bobath Approach On Hemiplegic Shoulder Pain

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