NCT05958732

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

May 9, 2023

Last Update Submit

July 14, 2023

Conditions

Keywords

StrokeBalance,Coordinationmini-mental scaleBBSCognition

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Somato-sensorial exercises therapyOther: Conventional Therapy

Control group

OTHER

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.

Other: Conventional Therapy

Interventions

It includes exercises, which is already mentioned in the arm description.

Experimental Group

It Includes routine exercises for the stroke patient the detail is already given in the arm description.

Control groupExperimental Group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female gender.
  • Sub-acute hemiplegic stroke patients.
  • Age 30 or older.

You may not qualify if:

  • Other comorbid conditions.
  • Neurological diseases other than stroke are excluded
  • Severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa Tameer-e-Millat University Islamabad

Islamabad, Fedral, 44000, Pakistan

RECRUITING

Related 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.

    PMID: 26957757BACKGROUND
  • 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.

    PMID: 32449959BACKGROUND
  • 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.

    PMID: 26504340BACKGROUND
  • 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.

    PMID: 31088342BACKGROUND
  • 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.

    PMID: 34653188BACKGROUND
  • 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.

    PMID: 30656163BACKGROUND
  • 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.

    PMID: 29209731BACKGROUND
  • 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.

    PMID: 26891641BACKGROUND
  • 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.

    PMID: 25013283BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Roshneck Haneed, MS-PT*

    Shifa Tameer-e-Millat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manan Haider, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be masked for the treatment groups. Non of the participants know to which treatment group they are assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 9, 2023

First Posted

July 25, 2023

Study Start

May 9, 2023

Primary Completion

July 25, 2023

Study Completion

July 31, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations