Impact of Rehabilitation Team on Disability Among Stroke Patients

NCT ID: NCT05165667

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

team meeting

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

Group Type EXPERIMENTAL

rehabilitation team

Intervention Type OTHER

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.

patient

they will be the subject

Group Type ACTIVE_COMPARATOR

rehabilitation team

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rehabilitation team

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Exclusion Criteria

* Seriously ill patients like unconsciousness, recent MI, unstable angina and Bronchial asthma, Dyslipidemia
* Uncontrolled diabetes mellitus, hypertension
* Patient with significant cognitive deficit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Farzana Khan Shoma

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Farzana Khan Shoma

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

shoma

Identifier Type: -

Identifier Source: org_study_id