StrokeNCT05941078
ICF Activity and Participation Needs in Post-stroke Patients
A study testing ICF-based post-stroke rehabilitation program in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- ICF-based post-stroke rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2021to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Participants with neurological disabilities other than the stroke condition.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Society for Rehabilitation Cheng Tak Yim Day Rehabilitation and Care Centre
Hong Kong
About this study
Official title: An International Classification of Functioning, Disability and Health (ICF)-Based Post-stroke Program for Meeting Activity and Participation Needs in Patients
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- ICF-based post-stroke rehabilitation program
- Keywords
- ICF, Stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF-based post-stroke rehabilitation programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ICF-based post-stroke rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start12 Apr 2021
- Primary completion27 Apr 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Society for Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Che Hin Chetwyn Chan, PhD, Study chair, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941078
- Sponsor's protocol ID
- PolyU RS ICF01
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38020626
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Classification of Functioning, Disability and Health (ICF)-Based Post-stroke Program for Meeting Activity and Participation Needs in Patients
- ClinicalTrials.gov ID
- NCT05941078
- Acronym / sponsor ID
- PolyU RS ICF01
- Conditions
- Stroke
- Keywords
- ICF, Stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Society for Rehabilitation
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICF-based post-stroke rehabilitation program group | Experimental | Behavioral: ICF-based post-stroke rehabilitation programThe 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Participants with neurological disabilities other than the stroke condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICF-based post-stroke rehabilitation programPatients 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. | Behavioural | ICF-based post-stroke rehabilitation program group |
Primary outcome
Modified Barthel Index
Time frame: Baseline
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
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.
Lawton Instrumental Activities of Daily Living Scale
Time frame: Baseline
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
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.
Elderly Mobility Scale
Time frame: Baseline
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
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.
Therapy Outcome Measure
Time frame: Baseline
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
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: Baseline
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
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.
Functional Test for the Hemiplegic Upper Extremity
Time frame: Baseline
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
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.
Oxford Cognitive Screen
Time frame: Baseline
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
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.
3 secondary outcomes
Goal Attainment Scale
Time frame: Baseline
Stroke Specific Quality of Life Scale
Time frame: Baseline
Stroke Specific Quality of Life Scale
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Derived from this study: PubMed 38020626Wong 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Che Hin Chetwyn Chan, PhD study chair
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICF-based post-stroke rehabilitation program in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barthel Index (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.