Skip to main content
Clinical Trials/NCT05941078
NCT05941078
Completed
Not Applicable

An International Classification of Functioning, Disability and Health (ICF)-Based Post-stroke Program for Meeting Activity and Participation Needs in Patients

The Hong Kong Polytechnic University1 site in 1 country55 target enrollmentApril 12, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
The Hong Kong Polytechnic University
Enrollment
55
Locations
1
Primary Endpoint
Modified Barthel Index
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
July 21, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • had a diagnosis of stroke with an onset no more than 24 months,
  • were medically stable,
  • were able to transfer or walk with no more than one item of assistance, and
  • were able to tolerate at least 2 hours of active rehabilitation treatment.
  • Exclusion criteria:
  • Participants with neurological disabilities other than the stroke condition.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Modified Barthel Index

Time Frame: Up to 12 weeks

It measures the level of self-care management activities. Scores for the bladder, bowel, ambulation (indoor walking), stairs, dressing, feeding and on and off toilet items range from 0 to 10; transfer (bed mobility, sitting and floor), ambulation (outdoor walking), personal hygiene and bathing items range from 0 to 5. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.

Elderly Mobility Scale

Time Frame: Up to 12 weeks

It measures the mobility level. The lying to sitting and sitting to lying items range from 0 to 2. The functional reach item ranges from 0 to 4. Other items, including sit to stand, stand, gait and time walk, range from 0 to 3. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.

Functional Test for the Hemiplegic Upper Extremity

Time Frame: Up to 12 weeks

It measures the recovery of the hemiplegic upper extremity. The score ranges from level 1 to level 7 based on Brunnstrom's developmental stages of stroke recovery. A lower level reveals the severe impairment of the upper extremity to perform simple hand movements. A higher level indicates less or no impairments on the upper extremity to perform fine hand functional tasks.

Lawton Instrumental Activities of Daily Living Scale

Time Frame: Up to 12 weeks

It measures the level of independent living. All items in the scale range from 0 to 3. A higher score in each item indicates a better independence level, and vice versa for the dependence level on caregivers.

Therapy Outcome Measure

Time Frame: Up to 12 weeks

It assesses patients' abilities and difficulties in terms of their impairment, activity, participation, and well-being in expressive and receptive language abilities. All items range from 0 to 5. A lower score reflects severely impaired language abilities, while scores close to 5 indicate less impaired or no impairment in language abilities.

Manual Muscle Testing - Lower Extremity

Time Frame: Up to 12 weeks

It measures lower extremity muscle strength impairments. The score ranges from 0 to 5. A lower score indicates a trend of weak or no movements detected on the lower extremity. A higher score indicates a trend of slight decline or no impairments in muscle contraction under full resistance.

Oxford Cognitive Screen

Time Frame: Up to 12 weeks

It measures stroke-induced cognitive disabilities. Areas include attention (score ranges from 0 to 63), memory (score ranges from 0 to 12), language (score ranges from 0 to 22), praxis (score ranges from 0 to 12) and number (score ranges from 0 to 4). A higher score indicates fewer impairments in the specific area, and vice versa for a lower score in the specific area.

Secondary Outcomes

  • Goal Attainment Scale(Baseline)
  • Stroke Specific Quality of Life Scale(Up to 12 weeks)

Study Sites (1)

Loading locations...

Similar Trials