Clinical trial NCT05941078: ICF Activity and Participation Needs in Post-stroke Patients
Official title: An International Classification of Functioning, Disability and Health (ICF)-Based Post-stroke Program for Meeting Activity and Participation Needs in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: ICF
Stroke rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Society for Rehabilitation
First posted: 2023-07-12
Enrollment: 55
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke is regarded as one of the leading causes of adult mortality and disability. Conventional rehabilitation programs for post-stroke patients focus on the augmentation of body functions. Their service delivery models are mostly operationalized according to the individual discipline's knowledge domain and practices. The International Classification of Functioning, Disability and Health (ICF) model provides a comprehensive framework which places focus on patients' activity and participation. It also emphasizes cross-disciplinary integration of service provision, patient-centred approach and personalization of treatment aims. This study is aimed to investigate how the ICF model can be integrated into the planning and implementation of personalized post-stroke programs, and evaluate the program's effectiveness in fulfilling the activity and participation needs of patients.

Detailed description: Stroke is a neurological disease and is regarded as one of the leading causes of adult mortality and disability. Post-stroke rehabilitation to promote functional recovery is important to restitute the brain tissue to relearn and compensate for the lost functions. Early rehabilitation to enhance neuroplasticity within three to six months of post-stroke is recommended to reduce neurological deficits caused by stroke. Promising stroke rehabilitation interventions to tackle mobility and cognitive impairments include fitness training, upper and lower extremity interventions, and reminiscence therapy.

The ICF model is proposed by the World Health Organization to describe health and health-related domains. It was developed based on the biopsychosocial model. Within the model, disability and functioning are identified as difficulties in 1) body functions and structure; 2) activity; and 3) participation. They are affected by the interaction between health conditions and contextual factors. The former is different diseases, disorders and injuries, while the latter consists of environmental factors and personal factors. The ICF model has been widely applied in assessment, treatment and evaluation in various disciplines. On top of the ICF model, there is a related neurorehabilitation process framed by ICF which makes up four steps. The first step is the assessment to understand the diagnosis and consequences of the current health condition of an individual. Followed by the goal-setting part to formulate short-term or long-term rehabilitation plans for patients' perspective. These two steps will inform the therapists of an ICF rehabilitation plan with corresponding ICF codes to describe patients' health conditions. The third step is to launch appropriate interventions based on the ICF rehabilitation plan, and the final step is the outcome measurements to review the appropriateness of interventions. Yet, a similar process has seldom been applied in post-stroke rehabilitation to guide the treatment program.

This project aims to investigate how the ICF model can be integrated into planning and implementation of an ICF-based post-stroke rehabilitation program (ICF-PSRP), and evaluate the program's effectiveness on fulfilling the activity and participation needs of patients.

Eligibility criteria: Inclusion Criteria:

1. had a diagnosis of stroke with an onset no more than 24 months,
2. were medically stable,
3. were able to transfer or walk with no more than one item of assistance, and
4. were able to tolerate at least 2 hours of active rehabilitation treatment.

Exclusion criteria:

1. Participants with neurological disabilities other than the stroke condition.

Primary outcomes:
measure: Modified Barthel Index
timeFrame: Baseline
measure: Modified Barthel Index
timeFrame: Up to 12 weeks
measure: Lawton Instrumental Activities of Daily Living Scale
timeFrame: Baseline
measure: Lawton Instrumental Activities of Daily Living Scale
timeFrame: Up to 12 weeks
measure: Elderly Mobility Scale
timeFrame: Baseline
measure: Elderly Mobility Scale
timeFrame: Up to 12 weeks
measure: Therapy Outcome Measure
timeFrame: Baseline
measure: Therapy Outcome Measure
timeFrame: Up to 12 weeks
measure: Manual Muscle Testing - Lower Extremity
timeFrame: Baseline
measure: Manual Muscle Testing - Lower Extremity
timeFrame: Up to 12 weeks
measure: Functional Test for the Hemiplegic Upper Extremity
timeFrame: Baseline
measure: Functional Test for the Hemiplegic Upper Extremity
timeFrame: Up to 12 weeks
measure: Oxford Cognitive Screen
timeFrame: Baseline
measure: Oxford Cognitive Screen
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Goal Attainment Scale
timeFrame: Baseline
measure: Stroke Specific Quality of Life Scale
timeFrame: Baseline
measure: Stroke Specific Quality of Life Scale
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Society for Rehabilitation Cheng Tak Yim Day Rehabilitation and Care Centre
Study officials:
affiliation: The Education University of Hong Kong
name: Che Hin Chetwyn Chan, PhD
role: STUDY_CHAIR
References: