Bobath Approach On Hemiplegic Shoulder Pain

Hemiplegic Shoulder Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768140
• Other study ID #: BAHSP
• Status: Completed
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: June 12, 2020

Study information

• Verified date: February 2021
• Source: Istanbul Arel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 12, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegic Shoulder Pain
• Shoulder Pain

Intervention

Procedure:
• Bobath treatment approach
scapulothoracic mobilization exercise, reaching in different directions in the supine position and upper extremity weight transfer exercise.
• Conventional physiotherapy
range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul	Bahçelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View 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. — View Citation

Hafsteinsdóttir 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

van der Lee JH, Wagenaar RC, Lankhorst GJ, Vogelaar TW, Devillé 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Brunnstrom Motor Recovery Staging value at 30 sessions, 6 weeks	Upper extremity motor evaluation,	First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Primary	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	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	First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks
Secondary	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	First evaluation: immediately before starting the treatment; the last evaluation: at the end of the treatment of 6 weeks