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AzTrials

Hemiplegic Shoulder PainBAHSPNCT04768140

Bobath Approach On Hemiplegic Shoulder Pain

A study testing Bobath treatment approach and Conventional physiotherapy in people with Hemiplegic Shoulder Pain, run by Istanbul Arel University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Hemiplegic Shoulder Pain
What is being tested?
Bobath treatment approach and Conventional physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2019to 12 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Istanbul, Bahçelievler, 34186

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Bobath treatment approach, Conventional physiotherapy
Keywords
Hemiplegia, hemiplegic shoulder pain, neurodevelopmental treatment, spasticity, stroke
Medical subject headings
Hemiplegia, Muscle Spasticity, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bobath treatment approachProcedure or surgery

    Also called Neurodevelopmental treatment

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

  • Conventional physiotherapyProcedure or surgery

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

Study groups in NCT04768140
Study groupRoleWhat they receive
Bobath groupExperimentalA 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.
Receives: Procedure: Bobath treatment approach; Procedure: Conventional physiotherapy
Conventional physiotherapy groupActive comparatorOnly conventional physiotherapy program was applied to this group.
Receives: Procedure: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (2)

  1. 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

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start10 Aug 2019
  3. Primary completion17 Mar 2020
  4. Study completion12 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768140
Sponsor's protocol ID
BAHSP
Acronym
BAHSP
Status last verified
Feb 2021
First submitted
19 Feb 2021
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22257503

  • 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.

    PubMed 16180951

  • 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.

    PubMed 10945420

  • 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.

    PubMed 15822545

  • 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.

    PubMed 16250190

  • 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.

    PubMed 17896054

  • 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.

    PubMed 17724559

  • 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.

    PubMed 15774435

  • 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.

    PubMed 10548673

  • 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.

    PubMed 22668675

  • 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.

    PubMed 15759530

Questions about this trial

What is this clinical trial studying?

A study testing Bobath treatment approach and Conventional physiotherapy in people with Hemiplegic Shoulder Pain, run by Istanbul Arel University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768140, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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