- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819266
Cognitive Postural Training for Hemineglect Patient After Stroke (CPT)
EFFECT OF COGNITIVE POSTURAL TRAINING ON POSTURAL STABILITY IN HEMISPATIAL NEGELCT PATIENTS POST STROKE
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alaa M Elbaroudy
- Phone Number: 201061547547
- Email: Alaaelbaroudy76@gmail.com
Study Locations
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Giza, Egypt
- The out patient clinic Faculty of physicaltherapy Cairo university
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Contact:
- Amal Y Yosef
- Phone Number: 0237617693
- Email: dean@pt.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients from both genders with hemispatial neglect due to first ever right cerebral hemisphere stroke (ischemic or hemorrhagic).
- Age of participants ranged from 45 to 65 years.
- Mild to moderate degree of unilateral spatial neglect according to Catherine Bergego scale.(Appendix VI)
- The duration of the stroke was at least six months.
- Body mass index ranged from 18.5 - 30 Kg/m2.
- Montreal cognitive assessment score more than 21 (Nasreddine, et al., 2005).
- Mini mental state examination score between 20 and 24 (Li, et al., 2016).
- Grade of spasticity less than two according to Modified Ashworth Scale (Harb and kishner 2022).
- Berg balance scale score less than 45 (Miranda-Cantellops, et al., 2022).
- Muscle power of lower limbs 3 or more
Exclusion Criteria:
21) Other brain injuries/illnesses, psychiatric, sever cognitive impairment, severe sensory or proprioceptive loss.
22) Other causes of cognitive dysfunction. 23) Severe apraxia, severe aphasia. 24) Drugs that affect balance or cognition 25) Ankle disorders (e.g.sprain), vestibular disorder 26) ophthalmic disorders, homonymous hemianopsia 27) Progressive neurological disease (e.g., dementia)
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 |
|---|---|
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Experimental: Cognitive postural training group
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CPT consisted of simultaneous performance of cognitive tasks and postural control activities to challenge cognitive-motor integration and postural stability.
Cognitive tasks included verbal fluency (e.g., naming animals), mental sequencing (e.g., reciting the months of the year in reverse order), and route-description tasks.
Training was progressively performed in different postural positions, including supine, sitting, sit-to-stand, and standing, according to the participant's abilities and level of postural control.
conventional balance training focuses on improving postural control, balance, and functional mobility.
Training included static and dynamic balance exercises performed in different postural positions, including sitting, sit-to-stand, and standing.
Exercises were progressed according to the participant's functional ability and balance performance and included weight-shifting activities, maintaining and changing the base of support, and functional balance activities.
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Active Comparator: Conventional physical therapy program group
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conventional balance training focuses on improving postural control, balance, and functional mobility.
Training included static and dynamic balance exercises performed in different postural positions, including sitting, sit-to-stand, and standing.
Exercises were progressed according to the participant's functional ability and balance performance and included weight-shifting activities, maintaining and changing the base of support, and functional balance activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Stability Index (OSI) - Biodex Balance System
Time Frame: Once at enrollment once at the end of treatment that will last 4 weeks
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Once at enrollment once at the end of treatment that will last 4 weeks
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Psotural stability- Berg Balance Score
Time Frame: Once at enrollment once at end of treatment that will last for 4 weeks
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Once at enrollment once at end of treatment that will last for 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cognitive Function - Montreal Cognitive Assessment (MoCA)
Time Frame: Once at enrollment once at end of treatment that will last for 4 weeks
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Once at enrollment once at end of treatment that will last for 4 weeks
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Global Cognitive Function - Mini-Mental State Examination (MMSE)
Time Frame: Once at enrollment once at end of treatment that will last for 4 weeks
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Once at enrollment once at end of treatment that will last for 4 weeks
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Hemispatial Neglect - Star Cancellation Test
Time Frame: Once at enrollment once at the end of treatment that will last 4 weeks
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Once at enrollment once at the end of treatment that will last 4 weeks
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Hemispatial Neglect - Catherine Bergego Scale (CBS)
Time Frame: Once at enrollment once at the end of treatment that will last 4 weeks
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Once at enrollment once at the end of treatment that will last 4 weeks
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Functional Independence - Barthel Index (BI)
Time Frame: Once at enrollment once at the end of treatment that will last 4 weeks
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Once at enrollment once at the end of treatment that will last 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- P.T.REC/012/005787 (Other Identifier: Cairo university)
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
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