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Effect of Body Awarness Therapy on Balance and Coordination in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Somato-sensorial exercises therapy
Conventional Therapy
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Balance,, Coordination, mini-mental scale, BBS, Cognition

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both male and female gender. Sub-acute hemiplegic stroke patients. Age 30 or older. Exclusion Criteria: Other comorbid conditions. Neurological diseases other than stroke are excluded Severe cognitive impairment

Sites / Locations

  • Shifa Tameer-e-Millat University IslamabadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group

Control group

Arm Description

The experimental group will receive body awareness therapy for 20 minutes.The following steps will be conducted, (1) Put your left hand on your right toe. (2) Put your right hand on your left toe. (3) Touch your heels. (4) Put your feet together. (5) Put your knees together. (6) Touch your right knee with your left hand. (7) Touch your left knee with your right hand. (8) Touch one knee and one foot. (9) Put your right hand on your left knee. (10) Put your left hand on your right knee. (11) Put your feet apart. (12) Touch your toes with your arms crossed. (13) Touch your thumbs to your toes. (14) Bend your knees. (15) Stamp your feet. Duration is 5 days a week for two weeks. Along with conventional therapy.

conventional training plan: (1) 5 minute warm up then, (2) static balance exercises, such as, Two leg stance, One Leg stance, and (3) dynamic balance exercises such as, sideway walking with crossover, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, Jogging end to end, (4) Coordination exercises such as, Tandem stepping, Finger to nose, Finger to finger, Sitting with Shifting weight in all directions, Rebound Phenomenon and cool down for 5 minutes.

Outcomes

Primary Outcome Measures

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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2023
Last Updated
July 14, 2023
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05958732
Brief Title
Effect of Body Awarness Therapy on Balance and Coordination in Stroke
Official Title
Effect of Body Awarness Therapy on Balance and Coordination in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Balance,, Coordination, mini-mental scale, BBS, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group will be receiving conventional therapy and body awareness therapy for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured. control group will receive conventional physical therapy treatment for 30 minutes, 5 days a week for two weeks. Balance and coordination is measured before the treatment and after two weeks of treatment session it is again measured.
Masking
Participant
Masking Description
The participants will be masked for the treatment groups. Non of the participants know to which treatment group they are assigned.
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will receive body awareness therapy for 20 minutes.The following steps will be conducted, (1) Put your left hand on your right toe. (2) Put your right hand on your left toe. (3) Touch your heels. (4) Put your feet together. (5) Put your knees together. (6) Touch your right knee with your left hand. (7) Touch your left knee with your right hand. (8) Touch one knee and one foot. (9) Put your right hand on your left knee. (10) Put your left hand on your right knee. (11) Put your feet apart. (12) Touch your toes with your arms crossed. (13) Touch your thumbs to your toes. (14) Bend your knees. (15) Stamp your feet. Duration is 5 days a week for two weeks. Along with conventional therapy.
Arm Title
Control group
Arm Type
Other
Arm Description
conventional training plan: (1) 5 minute warm up then, (2) static balance exercises, such as, Two leg stance, One Leg stance, and (3) dynamic balance exercises such as, sideway walking with crossover, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, Jogging end to end, (4) Coordination exercises such as, Tandem stepping, Finger to nose, Finger to finger, Sitting with Shifting weight in all directions, Rebound Phenomenon and cool down for 5 minutes.
Intervention Type
Other
Intervention Name(s)
Somato-sensorial exercises therapy
Intervention Description
It includes exercises, which is already mentioned in the arm description.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
It Includes routine exercises for the stroke patient the detail is already given in the arm description.
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
2 weeks
Title
Co-ordination
Description
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).
Time Frame
2 weeks
Title
Cognition
Description
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.
Time Frame
2 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female gender. Sub-acute hemiplegic stroke patients. Age 30 or older. Exclusion Criteria: Other comorbid conditions. Neurological diseases other than stroke are excluded Severe cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manan Haider, PhD
Phone
+923334839810
Email
m_manan.drs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshneck Haneed, MS-PT*
Organizational Affiliation
Shifa Tameer-e-Millat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa Tameer-e-Millat University Islamabad
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manan Haider
Phone
+923334839819
Email
m_manan.drs@stmu.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26957757
Citation
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Results Reference
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32449959
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.
Results Reference
background
PubMed Identifier
26504340
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.
Results Reference
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PubMed Identifier
31088342
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.
Results Reference
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PubMed Identifier
34653188
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.
Results Reference
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PubMed Identifier
30656163
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.
Results Reference
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PubMed Identifier
29209731
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.
Results Reference
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PubMed Identifier
26891641
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.
Results Reference
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PubMed Identifier
25013283
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.
Results Reference
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Effect of Body Awarness Therapy on Balance and Coordination in Stroke

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