- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958732
Effect of Body Awarness Therapy on Balance and Coordination in Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manan Haider, PhD
- Phone Number: +923334839810
- Email: m_manan.drs@stmu.edu.pk
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 44000
- Recruiting
- Shifa Tameer-e-Millat University Islamabad
-
Contact:
- Manan Haider
- Phone Number: +923334839819
- Email: m_manan.drs@stmu.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
It includes exercises, which is already mentioned in the arm description.
It Includes routine exercises for the stroke patient the detail is already given in the arm description.
|
|
Other: Control group
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.
|
It Includes routine exercises for the stroke patient the detail is already given in the arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 2 weeks
|
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
|
|
Co-ordination
Time Frame: 2 weeks
|
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
|
|
Cognition
Time Frame: 2 weeks.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roshneck Haneed, MS-PT*, Shifa Tameer-e-Millat University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 0352-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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