NCT04768140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

February 19, 2021

Last Update Submit

February 22, 2021

Conditions

Keywords

Hemiplegiahemiplegic shoulder painneurodevelopmental treatmentspasticitystroke

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • 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

  • 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

Other Outcomes (1)

  • Change from baseline Brunnstrom Motor Recovery Staging 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

Study Arms (2)

Bobath group

EXPERIMENTAL

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.

Procedure: Bobath treatment approachProcedure: Conventional physiotherapy

Conventional physiotherapy group

ACTIVE COMPARATOR

Only conventional physiotherapy program was applied to this group.

Procedure: Conventional physiotherapy

Interventions

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

Also known as: Neurodevelopmental treatment
Bobath group

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

Bobath groupConventional physiotherapy group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Bahçelievler, 34186, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 22257503BACKGROUND
  • 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.

    PMID: 16180951BACKGROUND
  • 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.

    PMID: 10945420BACKGROUND
  • 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.

    PMID: 15822545BACKGROUND
  • 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.

    PMID: 16250190BACKGROUND
  • 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.

    PMID: 17896054BACKGROUND
  • 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.

    PMID: 17724559BACKGROUND
  • 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.

    PMID: 15774435BACKGROUND
  • 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.

    PMID: 10548673BACKGROUND
  • 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.

    PMID: 22668675BACKGROUND
  • 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.

    PMID: 15759530BACKGROUND

MeSH Terms

Conditions

HemiplegiaMuscle SpasticityStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • NAZLI GÜNGÖR, PT,MSc

    Istanbul Arel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
SINGLE-BLIND TRIAL The patients were blinded to their group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A PROSPECTIVE, RANDOMIZED, CONTROLLED AND SINGLE-BLIND TRIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Physiotherapy and Rehabilitation, Health Sciences School

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 24, 2021

Study Start

August 10, 2019

Primary Completion

March 17, 2020

Study Completion

June 12, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations