Clinical trial NCT06140316: Biopsychosocial and Motor Predictor of Functional Recovery in Stroke Survivors
Official title: Biopsychosocial and Motor Predictor of Functional Recovery in Stroke Survivors, A Prospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Biopsychosocial
Functional recovery
Motor predictors
Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 104
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Functional Ambulatory Classification
timeFrame: 8 weeks
measure: Fugl-Meyer Assessment
timeFrame: 8 weeks
measure: Mini-Balance Evaluation Systems Test
timeFrame: 8 weeks
measure: Modified Barthel Index
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 8 weeks
measure: National Institute of health Stroke Scale
timeFrame: 8 weeks
measure: Motricity Score
timeFrame: 8 weeks
measure: Modified Ashworth Scale
timeFrame: 8 weeks
measure: Trunk Control test
timeFrame: 8 weeks
measure: Functional Independence Measure
timeFrame: 8 weeks
measure: Recovery Locus of Control Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: DHQ Dera Ghazi Khan
state: Punjab
Study officials:
affiliation: Riphah International University Pakistan
name: Aruba Saeed, PHD*
role: PRINCIPAL_INVESTIGATOR
References: