ICF Activity and Participation Needs in Post-stroke Patients

NCT05941078 | Completed

• 1 other identifier: PolyU RS ICF01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

ICF; Stroke rehabilitation

Outcome Measures

Primary Outcomes (14)

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

• 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.

  Baseline

• 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.

  Up to 12 weeks

Secondary Outcomes (3)

• Goal Attainment Scale

  Baseline

• Stroke Specific Quality of Life Scale

  Baseline

• Stroke Specific Quality of Life Scale

  Up to 12 weeks

Study Arms (1)

ICF-based post-stroke rehabilitation program group

EXPERIMENTAL

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.

Behavioral: ICF-based post-stroke rehabilitation program

Interventions

ICF-based post-stroke rehabilitation program BEHAVIORAL

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.

ICF-based post-stroke rehabilitation program group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Participants with neurological disabilities other than the stroke condition.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The Hong Kong Society for Rehabilitation: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Related Publications (1)

• Wong MN, Cheung MK, Ng YM, Yuan HL, Lam BY, Fu SN, Chan CCH. International Classification of Functioning, Disability, and Health-based rehabilitation program promotes activity and participation of post-stroke patients. Front Neurol. 2023 Nov 3;14:1235500. doi: 10.3389/fneur.2023.1235500. eCollection 2023.

  PMID: 38020626 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Che Hin Chetwyn Chan, PhD

  The Education University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 12, 2023
• Study Start: April 12, 2021
• Primary Completion: April 27, 2022
• Study Completion: July 21, 2022
• Last Updated: July 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)