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Impact of Rehabilitation Team on Disability Among Stroke Patients

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rehabilitation team
Sponsored by
Farzana Khan Shoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • 1st episode of stroke patients after neurological stabilization
  • Patients having gross disability, such as mobility,speech,self care, vocational problem,sphinter control
  • Stroke survivors attending within 4 weeks of incidence
  • Patients age > 18 years;
  • Written consent to participate in the protocol, signed by the patient Exclusion Criteria
  • Seriously ill patients like unconsciousness, recent MI, unstable angina and Bronchial asthma, Dyslipidemia
  • Uncontrolled diabetes mellitus, hypertension
  • Patient with significant cognitive deficit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    team meeting

    patient

    Arm Description

    the team meeting will help to measure the effectiveness of rehabilitation team meeting on disability among stroke patinets in Functional Independent Measure (FIM) score

    they will be the subject

    Outcomes

    Primary Outcome Measures

    Impact of rehabilitation team on disability among stroke patients
    Rehabilitation team meeting provides better functional recovery than conventional rehabilitation therapy among stroke patients

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2021
    Last Updated
    December 14, 2021
    Sponsor
    Farzana Khan Shoma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05165667
    Brief Title
    Impact of Rehabilitation Team on Disability Among Stroke Patients
    Official Title
    Impact of Rehabilitation Team on Disability Among Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Farzana Khan Shoma

    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
    Physical Medicine and Rehabilitation (PMR) is a newer rapidly growing specialty in Bangladesh. Because of the improved primary care and acute care services people are living longer with a raised demand of hospitalizations of patients with disabilities resulting from trauma and disease conditions. There is necessity of developing a better service outlet of the patients withpain and paralysis in association of various disabilities. Patients undergoing comprehensive rehabilitation require the services of multiple health care providers who possess unique skills, training, and expertise that are employed for the full restoration of these patients' function and their optimal reintegration into all aspects of life. Assessment, treatment planning, and therapy are often provided by rehabilitation clinicians specializing in occupational therapy, physical therapy, prosthetics and orthotics, psychology and recreational therapy, speech and language pathology, rehabilitation nursing, social work, dietary science, case management, and others. Rapidly expanding Bangabandhu Sheikh Mujib Medical University (BSMMU) has been working as the center of excellence for patient managements and postgraduate medical education in Bangladesh. Rehabilitation Medicine wards Indoor services started during June 2015 and over a total of 600 patients were treated in the facilities so far. Rehabilitation team meeting occurs in the department of PMR in the many countries of the world. Still there is no team meeting in PMR department in our country. So we started Rehabilitation team meeting in our department in BSMMU for the wellbeing of the patient and this will increase the reputation of this University.
    Detailed Description
    Background: Physical Medicine and Rehabilitation (PMR) is a newer rapidly growing specialty in Bangladesh. Because of the improved primary care and acute care services people are living longer with a raised demand of hospitalizations of patients with disabilities resulting from trauma and disease conditions. There is necessity of developing a better service outlet of the patients withpain and paralysis in association of various disabilities. Patients undergoing comprehensive rehabilitation require the services of multiple health care providers who possess unique skills, training, and expertise that are employed for the full restoration of these patients' function and their optimal reintegration into all aspects of life. Assessment, treatment planning, and therapy are often provided by rehabilitation clinicians specializing in occupational therapy, physical therapy, prosthetics and orthotics, psychology and recreational therapy, speech and language pathology, rehabilitation nursing, social work, dietary science, case management, and others. Rapidly expanding Bangabandhu Sheikh Mujib Medical University (BSMMU) has been working as the center of excellence for patient managements and postgraduate medical education in Bangladesh. Rehabilitation Medicine wards Indoor services started during June 2015 and over a total of 600 patients were treated in the facilities so far. Rehabilitation team meeting occurs in the department of PMR in the many countries of the world. Still there is no team meeting in PMR department in our country. So we started Rehabilitation team meeting in our department in BSMMU for the wellbeing of the patient and this will increase the reputation of this University. Objective: To evaluate the impact of rehabilitation team on disability among stroke patinets attending in the Department of Physical Medicine and Rehabilitation (PMR) in BSMMU Materials & Methods: A randomized controlled trial will be conducted in Dept. of Physical Medicine and Rehabilitation, BSMMU, Dhaka for duration of one year after clearance from IRB. A number of total 136 patients who have disability after stroke will be selected as per inclusion and exclusion criteria. Patients will be randomly allocated by lottery in two groups- group A (received Rehabilitation Team Meeting service) and group B (received conventional Rehabilitation treatment). The meeting comprised physiotherapist, occupational therapist, rehabilitation nurse, speech and language therapists, social worker, nutritionist, psychologists under the team leader guidance by physiatrist. Respondents of both groups will be assessed to see the effects of treatment at 6th weeks, 12th weeks and 24th weeks. Outcomes will be measured by FIM (Functional independence Measure) scores. Process of obtaining consent: Consent form will be a written statement. This study result will add benefit to the society by providing information about rehabilitation . Use of new drugs: No experimental drug or placebo will be used for this study. Use hospital records: Hospital records will not be used in our study. Risk and Benefit: The nature and purpose of the study will be informed in detail to all participants. Voluntary participations will be encouraged. There will be no potential physical, psychological, legal and social risk to the subjects. This study will bring fruitful medical information useful for the study subjects and other patients who will be undergoing the provided treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    team meeting
    Arm Type
    Experimental
    Arm Description
    the team meeting will help to measure the effectiveness of rehabilitation team meeting on disability among stroke patinets in Functional Independent Measure (FIM) score
    Arm Title
    patient
    Arm Type
    Active Comparator
    Arm Description
    they will be the subject
    Intervention Type
    Other
    Intervention Name(s)
    rehabilitation team
    Intervention Description
    The meeting comprised physiotherapist, occupational therapist, rehabilitation nurse, speech and language therapists, social worker, nutritionist, psychologists under the team leader guidance by physiatrist. Respondents of both groups will be assessed to see the effects of treatment at 6 th weeks, 12 th weeks and 24 th weeks. Outcomes will be measured by FIM (Functional independence Measure) scores.
    Primary Outcome Measure Information:
    Title
    Impact of rehabilitation team on disability among stroke patients
    Description
    Rehabilitation team meeting provides better functional recovery than conventional rehabilitation therapy among stroke patients
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria 1st episode of stroke patients after neurological stabilization Patients having gross disability, such as mobility,speech,self care, vocational problem,sphinter control Stroke survivors attending within 4 weeks of incidence Patients age > 18 years; Written consent to participate in the protocol, signed by the patient Exclusion Criteria Seriously ill patients like unconsciousness, recent MI, unstable angina and Bronchial asthma, Dyslipidemia Uncontrolled diabetes mellitus, hypertension Patient with significant cognitive deficit

    12. IPD Sharing Statement

    Learn more about this trial

    Impact of Rehabilitation Team on Disability Among Stroke Patients

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