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
About this trial
This is an interventional supportive care trial for Stroke
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
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
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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