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ICF Activity and Participation Needs in Post-stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ICF-based post-stroke rehabilitation program
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring ICF, Stroke rehabilitation

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Society for Rehabilitation Cheng Tak Yim Day Rehabilitation and Care Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICF-based post-stroke rehabilitation program group

Arm Description

The ICF-PSRP based on the ICF Core Set for Stroke targeted to facilitate patients' functional improvement, and community and social reintegration. Duration of the ICF-PSRP was eight or 12 weeks, comprising of 30 or 48 two-hour sessions depending on the patients' needs and progress.

Outcomes

Primary Outcome Measures

Modified Barthel Index
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.
Modified Barthel Index
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.
Lawton Instrumental Activities of Daily Living Scale
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.
Lawton Instrumental Activities of Daily Living Scale
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.
Elderly Mobility Scale
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.
Elderly Mobility Scale
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.
Therapy Outcome Measure
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.
Therapy Outcome Measure
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
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.
Manual Muscle Testing - Lower Extremity
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.
Functional Test for the Hemiplegic Upper Extremity
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.
Functional Test for the Hemiplegic Upper Extremity
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.
Oxford Cognitive Screen
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.
Oxford Cognitive Screen
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 Outcome Measures

Goal Attainment Scale
It enables patients to set individualised achievable goals at the beginning of the program. The score ranges from -2 to +2. All patients begin at the level of -2. A zero score indicates patients' improvements to reach their goal(s). A +2 score indicates an out-of-expectation improvement in the program.
Stroke Specific Quality of Life Scale
It measures post-stroke patients' health-related quality of life with good internal consistency. All items range from 1 to 5. A lower item score implies a disagreement or requirement of total help from patients' perspectives, and vice versa for a higher item score. The same interpretation applies to the sum of scores.
Stroke Specific Quality of Life Scale
It measures post-stroke patients' health-related quality of life with good internal consistency. All items range from 1 to 5. A lower item score implies a disagreement or requirement of total help from patients' perspectives, and vice versa for a higher item score. The same interpretation applies to the sum of scores.

Full Information

First Posted
June 20, 2023
Last Updated
July 9, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
The Hong Kong Society for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT05941078
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The Hong Kong Society for Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
ICF, Stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICF-based post-stroke rehabilitation program group
Arm Type
Experimental
Arm Description
The ICF-PSRP based on the ICF Core Set for Stroke targeted to facilitate patients' functional improvement, and community and social reintegration. Duration of the ICF-PSRP was eight or 12 weeks, comprising of 30 or 48 two-hour sessions depending on the patients' needs and progress.
Intervention Type
Behavioral
Intervention Name(s)
ICF-based post-stroke rehabilitation program
Intervention Description
Patients completed an intake interview with a case therapist for an initial assessment and setting of personal treatment goals. The therapist assisted the patient with setting goals that were related to their life roles and functional gaps in terms of body function and activity and participation. Patients' personalized treatment plans were composed in case conferences. The treatment program contents were organized as ICF-based body function and activity and participation intervention modules. Each of the occupational therapy, physiotherapy, and speech therapy disciplines set the aims and developed the training contents, intensities, durations, and upgrading and completion criteria.
Primary Outcome Measure Information:
Title
Modified Barthel Index
Description
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.
Time Frame
Baseline
Title
Modified Barthel Index
Description
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.
Time Frame
Up to 12 weeks
Title
Lawton Instrumental Activities of Daily Living Scale
Description
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.
Time Frame
Baseline
Title
Lawton Instrumental Activities of Daily Living Scale
Description
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.
Time Frame
Up to 12 weeks
Title
Elderly Mobility Scale
Description
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.
Time Frame
Baseline
Title
Elderly Mobility Scale
Description
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.
Time Frame
Up to 12 weeks
Title
Therapy Outcome Measure
Description
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.
Time Frame
Baseline
Title
Therapy Outcome Measure
Description
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.
Time Frame
Up to 12 weeks
Title
Manual Muscle Testing - Lower Extremity
Description
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.
Time Frame
Baseline
Title
Manual Muscle Testing - Lower Extremity
Description
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.
Time Frame
Up to 12 weeks
Title
Functional Test for the Hemiplegic Upper Extremity
Description
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.
Time Frame
Baseline
Title
Functional Test for the Hemiplegic Upper Extremity
Description
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.
Time Frame
Up to 12 weeks
Title
Oxford Cognitive Screen
Description
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.
Time Frame
Baseline
Title
Oxford Cognitive Screen
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Goal Attainment Scale
Description
It enables patients to set individualised achievable goals at the beginning of the program. The score ranges from -2 to +2. All patients begin at the level of -2. A zero score indicates patients' improvements to reach their goal(s). A +2 score indicates an out-of-expectation improvement in the program.
Time Frame
Baseline
Title
Stroke Specific Quality of Life Scale
Description
It measures post-stroke patients' health-related quality of life with good internal consistency. All items range from 1 to 5. A lower item score implies a disagreement or requirement of total help from patients' perspectives, and vice versa for a higher item score. The same interpretation applies to the sum of scores.
Time Frame
Baseline
Title
Stroke Specific Quality of Life Scale
Description
It measures post-stroke patients' health-related quality of life with good internal consistency. All items range from 1 to 5. A lower item score implies a disagreement or requirement of total help from patients' perspectives, and vice versa for a higher item score. The same interpretation applies to the sum of scores.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: 1. Participants with neurological disabilities other than the stroke condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Che Hin Chetwyn Chan, PhD
Organizational Affiliation
The Education University of Hong Kong
Official's Role
Study Chair
Facility Information:
Facility Name
The Hong Kong Society for Rehabilitation Cheng Tak Yim Day Rehabilitation and Care Centre
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The collected data, such as treatment goal contents, assessment results and demographic variables, may reveal participants' identities. Further, participants were not informed about sharing their information with parties other than the research team and rehabilitation centre.

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ICF Activity and Participation Needs in Post-stroke Patients

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