StrokeNCT06140316
Biopsychosocial and Motor Predictor of Functional Recovery in Stroke Survivors
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Up to the researcher knowledge, there is currently limited literature available that thoroughly investigates the biopsychosocial and motor predictors of functional recovery in stroke survivors. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2023to 10 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Design: The study design is a prospective cohort study, where a group of participants will be followed over time to observe changes in patient outcomes after receiving physiotherapy interventions. Study Setting: Data for this study will be collected from the Dera Ghazi Khan Teaching Hospital and the affiliated physiotherapy center. Study Duration: The study will span a period of six months, commencing after receiving approval from the Bioethical Review Board (BASR). Sample Size: The study will include a total of 104 participants.
Who may be able to join
- Either gender
- Patients with age between 45 to 65 years.
- Ischemic stroke patients
- Patients having stroke from 3 to 7 days at the time of recruitment
Who cannot join
- Patients with previous stroke history
- Presence or history of intracranial tumor, with/without tumor bleeding.
- Presence or history of traumatic brain injury.
- Presence or history of encephalopathy/myelopathy.
- Presence or history of central nervous system infection/ inflammation.
- Presence or history of degenerative central or peripheral nervous system disease, including neuropathy, neuronopathy, or myopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biopsychosocial and Motor Predictor of Functional Recovery in Stroke Survivors, A Prospective Cohort
Up to the researcher knowledge, there is currently limited literature available that thoroughly investigates the biopsychosocial and motor predictors of functional recovery in stroke survivors. Previous studies have only focused on examining these factors individually, without considering their collective impact on functional outcomes. As a result, there is a significant research gap in understanding how these factors interact and influence the recovery process. By integrating the biopsychosocial model with motor predictors, this study will provide a unique and comprehensive perspective on the recovery trajectory of stroke survivors.
Read the detailed description
Stroke is a leading cause of impairment, with 20% of survivors requiring institutional care for 3 months afterward, and 15% to 30% being disabled permanently. A review in 2016 has shown that over the past four decades, a statistically significant trend in stroke incidence rate declined in high-income countries (42%) but in low- to middle-income countries, it was increasing to a greater than 100% trend over time. Functional recovery after a stroke is a complex and multifactorial process influenced by a combination of biopsychosocial and motor factors. Biopsychosocial factors encompass the interplay between biological, psychological, and social aspects of an individual's life that can influence their recovery trajectory. Motor factors, on the other hand, specifically focus on impairments and functional limitations related to movement and mobility. Only a few studies have explored the role of various biopsychosocial and motor factors in predicting functional recovery in stroke survivors and these studies have focused on the factors individually. Biologically, factors such as lesion location, stroke severity, age, and comorbidities have been shown to influence recovery outcomes. Psychologically, factors like motivation, self-efficacy, depression, and cognitive function can significantly impact a person's ability to engage in rehabilitation and regain functional abilities. Social factors, including social support, access to rehabilitation services, and socioeconomic status also play a critical role in facilitating or hindering recovery.
Likewise, motor factors, such as motor impairment, balance, gait, speed, and functional mobility are strong predictors of functional recovery. Motor recovery is closely associated with the reorganization of neural pathways and the restoration of motor function. Up to the researcher knowledge, there is currently limited literature available that thoroughly investigates the biopsychosocial and motor predictors of functional recovery in stroke survivors. Previous studies have only focused on examining these factors individually, without considering their collective impact on functional outcomes. As a result, there is a significant research gap in understanding how these factors interact and influence the recovery process.
- Conditions
- Stroke
- Keywords
- Biopsychosocial, Functional recovery, Motor predictors, Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulatory Classification
A classification system that categorizes individuals based on their level of functional ambulation, ranging from non-ambulatory to fully independent ambulation.
Measured: 8 weeks
Fugl-Meyer Assessment
A standardized assessment that evaluates the motor function and recovery of the lower limbs and upper limb, including voluntary movement, reflex activity, coordination, and balance.
Measured: 8 weeks
Mini-Balance Evaluation Systems Test
A clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.
Measured: 8 weeks
Modified Barthel Index
A widely used functional assessment tool that measures a person's ability to perform activities of daily living (ADLs) independently, including self-care tasks such as bathing, dressing, and toileting
Measured: 8 weeks
Hospital Anxiety and Depression Scale
A self-report questionnaire designed to assess symptoms of anxiety and depression in individuals with physical health conditions, providing a measure of emotional well-being and psychological distress.
Measured: 8 weeks
National Institute of health Stroke Scale
The NIH Stroke Scale (NIHSS) is a widely used tool to assess and measure the severity of neurological deficits after a stroke.
Measured: 8 weeks
Motricity Score
The Motricity Scale is a standardized assessment tool designed to evaluate motor function and strength in individuals with stroke.
Measured: 8 weeks
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to measure spasticity in individuals with neurological conditions.
Measured: 8 weeks
Trunk Control test
The trunk control test is a clinical assessment that evaluates the stability and control of the core region of the body, helping determine functional abilities and guide rehabilitation interventions.
Measured: 8 weeks
Functional Independence Measure
The Functional Independence Measure (FIM) is a standardized assessment tool that measures a person's level of independence in daily activities.
Measured: 8 weeks
Recovery Locus of Control Scale
The Recovery Locus of Control Scale is a psychometric tool used to assess an individual's perception of control over their own recovery process. It
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Nov 2023
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PHD*, Principal investigator, Riphah International University Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140316
- Sponsor's protocol ID
- REC/0243 Aniqa Nasreen
- Status last verified
- May 2024
- First submitted
- 15 Nov 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychosocial and Motor Predictor of Functional Recovery in Stroke Survivors, A Prospective Cohort
- ClinicalTrials.gov ID
- NCT06140316
- Acronym / sponsor ID
- REC/0243 Aniqa Nasreen
- Conditions
- Stroke
- Keywords
- Biopsychosocial, Functional recovery, Motor predictors, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to the researcher knowledge, there is currently limited literature available that thoroughly investigates the biopsychosocial and motor predictors of functional recovery in stroke survivors. Previous studies have only focused on examining these factors individually, without considering their collective impact on functional outcomes. As a result, there is a significant research gap in understanding how these factors interact and influence the recovery process. By integrating the biopsychosocial model with motor predictors, this study will provide a unique and comprehensive perspective on the recovery trajectory of stroke survivors.
Detailed description
Stroke is a leading cause of impairment, with 20% of survivors requiring institutional care for 3 months afterward, and 15% to 30% being disabled permanently. A review in 2016 has shown that over the past four decades, a statistically significant trend in stroke incidence rate declined in high-income countries (42%) but in low- to middle-income countries, it was increasing to a greater than 100% trend over time. Functional recovery after a stroke is a complex and multifactorial process influenced by a combination of biopsychosocial and motor factors. Biopsychosocial factors encompass the interplay between biological, psychological, and social aspects of an individual's life that can influence their recovery trajectory. Motor factors, on the other hand, specifically focus on impairments and functional limitations related to movement and mobility. Only a few studies have explored the role of various biopsychosocial and motor factors in predicting functional recovery in stroke survivors and these studies have focused on the factors individually. Biologically, factors such as lesion location, stroke severity, age, and comorbidities have been shown to influence recovery outcomes. Psychologically, factors like motivation, self-efficacy, depression, and cognitive function can significantly impact a person's ability to engage in rehabilitation and regain functional abilities. Social factors, including social support, access to rehabilitation services, and socioeconomic status also play a critical role in facilitating or hindering recovery.
Likewise, motor factors, such as motor impairment, balance, gait, speed, and functional mobility are strong predictors of functional recovery. Motor recovery is closely associated with the reorganization of neural pathways and the restoration of motor function. Up to the researcher knowledge, there is currently limited literature available that thoroughly investigates the biopsychosocial and motor predictors of functional recovery in stroke survivors. Previous studies have only focused on examining these factors individually, without considering their collective impact on functional outcomes. As a result, there is a significant research gap in understanding how these factors interact and influence the recovery process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Design: The study design is a prospective cohort study, where a group of participants will be followed over time to observe changes in patient outcomes after receiving physiotherapy interventions. Study Setting: Data for this study will be collected from the Dera Ghazi Khan Teaching Hospital and the affiliated physiotherapy center. Study Duration: The study will span a period of six months, commencing after receiving approval from the Bioethical Review Board (BASR). Sample Size: The study will include a total of 104 participants.
Key inclusion criteria (4 listed)
- Either gender
- Patients with age between 45 to 65 years.
- Ischemic stroke patients
- Patients having stroke from 3 to 7 days at the time of recruitment
Key exclusion criteria (6 listed)
- Patients with previous stroke history
- Presence or history of intracranial tumor, with/without tumor bleeding.
- Presence or history of traumatic brain injury.
- Presence or history of encephalopathy/myelopathy.
- Presence or history of central nervous system infection/ inflammation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Ambulatory Classification
Time frame: 8 weeks
A classification system that categorizes individuals based on their level of functional ambulation, ranging from non-ambulatory to fully independent ambulation.
Fugl-Meyer Assessment
Time frame: 8 weeks
A standardized assessment that evaluates the motor function and recovery of the lower limbs and upper limb, including voluntary movement, reflex activity, coordination, and balance.
Mini-Balance Evaluation Systems Test
Time frame: 8 weeks
A clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.
Modified Barthel Index
Time frame: 8 weeks
A widely used functional assessment tool that measures a person's ability to perform activities of daily living (ADLs) independently, including self-care tasks such as bathing, dressing, and toileting
Hospital Anxiety and Depression Scale
Time frame: 8 weeks
A self-report questionnaire designed to assess symptoms of anxiety and depression in individuals with physical health conditions, providing a measure of emotional well-being and psychological distress.
National Institute of health Stroke Scale
Time frame: 8 weeks
The NIH Stroke Scale (NIHSS) is a widely used tool to assess and measure the severity of neurological deficits after a stroke.
Motricity Score
Time frame: 8 weeks
The Motricity Scale is a standardized assessment tool designed to evaluate motor function and strength in individuals with stroke.
Modified Ashworth Scale
Time frame: 8 weeks
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to measure spasticity in individuals with neurological conditions.
Trunk Control test
Time frame: 8 weeks
The trunk control test is a clinical assessment that evaluates the stability and control of the core region of the body, helping determine functional abilities and guide rehabilitation interventions.
Functional Independence Measure
Time frame: 8 weeks
The Functional Independence Measure (FIM) is a standardized assessment tool that measures a person's level of independence in daily activities.
Recovery Locus of Control Scale
Time frame: 8 weeks
The Recovery Locus of Control Scale is a psychometric tool used to assess an individual's perception of control over their own recovery process. It
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PHD* principal investigator
Riphah International University Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulatory Classification (time frame: 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.