Bobath Approach On Hemiplegic Shoulder Pain

NCT ID: NCT04768140

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2020-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiplegic Shoulder Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Bobath treatment approach

Intervention Type PROCEDURE

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

Conventional physiotherapy

Intervention Type PROCEDURE

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

Conventional physiotherapy group

Only conventional physiotherapy program was applied to this group.

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bobath treatment approach

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

Intervention Type PROCEDURE

Conventional physiotherapy

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neurodevelopmental treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Arel University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NAZLI GÜNGÖR

Research Assistant, Department of Physiotherapy and Rehabilitation, Health Sciences School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

NAZLI GÜNGÖR, PT,MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul Arel University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Istanbul, Bahçelievler, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22257503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16180951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10945420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15822545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16250190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17896054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17724559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15774435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10548673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22668675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15759530 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BAHSP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.