Effect of Body Awarness Therapy on Balance and Coordination in Stroke

Stroke Clinical Trial

Official title:

Effect of Body Awarness Therapy on Balance and Coordination in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958732
• Other study ID #: IRB 0352-22
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2023
• Source: Shifa Tameer-e-Millat University
• Contact: Manan Haider, PhD
• Phone: +923334839810
• Email: m_manan.drs[@]stmu.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke is sudden disruption in central nervous system function due to disturbance of the blood flow circulation in the brain. Cerebrovascular accident (CVA), is the second most leading cause of mortality (5.5 million cases yearly). Its occurrence remains high, with 13.7 million annual incident cases globally. Ischemic strokes are more common with a prevalence ratio of 76-119 per 100,000 per year worldwide ). Stroke is a neurological disease that decrease sensorimotor functions by causing irreversible impairments to the nervous system due to cerebral vascular problems . Patients with balance and activity disturbance are indicated by reduce in body functions. It is very essential for CVA patients to improve balance stability and muscle power for recovery and for normal activities ). Balance is an essential factor for independent living. It is maintained by adjusting COG (Center of Gravity) over the BOS (Base of Support). These adjustments are done through sensational inputs from the vestibular, visual and somatosensory system and are maintained by brain.

Description:

Impairment of balance stability is common in stroke patients. Patients with cerebrovascular accident (CVA) present mainly with asymmetric standing balance that affects their stability limits, and leads to major difficulty in functional independence. A reduction in maintaining balance is one of the major element that adversely affect after stroke. Coordination is another important factor, which allows a person to perform purposeful movement. After cerebrovascular accidents mainly impairment in coordination may be an element in mobility and movement limitations. Restoring the coordinated movement after cerebrovascular accident in important in regaining normal living activities. Those patients who survive from stroke may experience instant changes in thinking, language, balance, coordination, proprioception, body functions and quality of life. Stroke rehabilitation is the restoring functions of the impaired body regions and it is a long and time taking process, both for patients and for rehabilitation teams. Body awareness therapy (BAT) is a physiotherapeutic restorative approach that examine the patient's condition and focus towards relearning self-awareness movements. Body awareness therapy helps in strengthening the patient and also performing in activities of daily living (ADLs). A basic movement is stimulation of center line by weight shifting from right towards left and rotatory movements around the center of body and vice versa. Movements can be achieved in supine, sitting and standing position. Unfortunately, no randomized controlled trial (RCT) study has so far evaluated the effect of body awareness therapy (BAT) on balance and coordination in stroke survivals. Therefore, the purpose of this study is to assess BAT on balance and coordination in patients with cerebrovascular accident (CVA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 31, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Both male and female gender.

2. Sub-acute hemiplegic stroke patients.

3. Age 30 or older.

Exclusion Criteria:

1. Other comorbid conditions.

2. Neurological diseases other than stroke are excluded

3. Severe cognitive impairment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Somato-sensorial exercises therapy
It includes exercises, which is already mentioned in the arm description.
• Conventional Therapy
It Includes routine exercises for the stroke patient the detail is already given in the arm description.

Locations

Country	Name	City	State
Pakistan	Shifa Tameer-e-Millat University Islamabad	Islamabad	Fedral

Sponsors (1)

Lead Sponsor	Collaborator
Shifa Tameer-e-Millat University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Bang DH, Cho HS. Effect of body awareness training on balance and walking ability in chronic stroke patients: a randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(1):198-201. doi: 10.1589/jpts.2016.198. Epub 2016 Jan 30. — View Citation

Barclay RE, Stevenson TJ, Poluha W, Semenko B, Schubert J. Mental practice for treating upper extremity deficits in individuals with hemiparesis after stroke. Cochrane Database Syst Rev. 2020 May 25;5(5):CD005950. doi: 10.1002/14651858.CD005950.pub5. — View Citation

Choi JU, Kang SH. The effects of patient-centered task-oriented training on balance activities of daily living and self-efficacy following stroke. J Phys Ther Sci. 2015 Sep;27(9):2985-8. doi: 10.1589/jpts.27.2985. Epub 2015 Sep 30. — View Citation

Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15. — View Citation

Kass B, Dornquast C, Meisel A, Holmberg C, Rieckmann N, Reinhold T. Cost-effectiveness of patient navigation programs for stroke patients-A systematic review. PLoS One. 2021 Oct 15;16(10):e0258582. doi: 10.1371/journal.pone.0258582. eCollection 2021. — View Citation

Kim JC, Lim JH. The effects of coordinative locomotor training on coordination and gait in chronic stroke patients: a randomized controlled pilot trial. J Exerc Rehabil. 2018 Dec 27;14(6):1010-1016. doi: 10.12965/jer.1836386.193. eCollection 2018 Dec. — View Citation

Kutlay S, Genc A, Gok H, Oztuna D, Kucukdeveci AA. Kinaesthetic ability training improves unilateral neglect and functional outcome in patients with stroke: A randomized control trial. J Rehabil Med. 2018 Feb 13;50(2):159-164. doi: 10.2340/16501977-2301. — View Citation

Lindvall MA, Anderzen Carlsson A, Forsberg A. Basic Body Awareness Therapy for patients with stroke: Experiences among participating patients and physiotherapists. J Bodyw Mov Ther. 2016 Jan;20(1):83-89. doi: 10.1016/j.jbmt.2015.06.004. Epub 2015 Jun 15. — View Citation

Yoo J, Jeong J, Lee W. The effect of trunk stabilization exercise using an unstable surface on the abdominal muscle structure and balance of stroke patients. J Phys Ther Sci. 2014 Jun;26(6):857-9. doi: 10.1589/jpts.26.857. Epub 2014 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance	The assessment tests need individual corporation and the assessment is about 15 to 20 minutes. Berg Balance Scale involves 14 different tasks that can be categorized into different domains. Each task is divided into five grades for assessing the level of stability and un-stability and grades are from zero to four. Zero is graded when the person is unable and not performing the task fully and four is given when the person is fully able and able to perform the task independently. However, the score of the Berg balance scale ranges from 0 to 56. The score can be calculated or measured after assessment. From zero to twenty (0-20) severe impairment. From score Twenty-one to forty (21-40) moderate impairment. From score forty-one to fifty-six (41-56) minimal impairment.	2 weeks
Primary	Co-ordination	The tests that can be performed to measure the coordination of the upper region and the lower region can be equilibrium and non-equilibrium tests.; The non-Equilibrium test is a simple and very effective clinical assessment screening test and would be assessed as the Finger nose test, Finger Finger Test, and Rebound Phenomena. For the lower limb heel-to-shin test, draw a circle test.; Equilibrium tests can be performed in a sitting position, in a standing position, and in a walking position. Coordination tests whether equilibrium or non-equilibrium can be assessed into five grades from 0 grade to 4 grade. Grade 0 (Activity Impossible) Grade 1 (severe Impairment) Grade 2 (moderate Impairment) Grade 3 (Minimal Impairment) Grade 4 ( normal Performance).	2 weeks
Primary	Cognition	The Mini-Mental State examination is used to check cognition, and orientation, registration, attention and calculation, and memory recall of the objects. The score of the mini-mental state examination ranges between 0 to 30. If the score ranges between thirty to twenty-four (30 to 24) then there is no cognitive impairment. If the score ranges between twenty-three to eighteen (23 to 18) then there is mild cognitive impairment. If the score ranges between seventeen to zero (17-0) then an individual is suffering from severe cognitive impairment.	2 weeks.