StrokeNCT01693341
A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
A study testing Care-giver mediated training in people with Stroke, run by Asia University at 1 site in Taiwan.
Trial summary
To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Care-giver mediated training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Jan 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
- No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)
Who cannot join
- Recurring strokes
- Mental or cognitive impairment
- Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
- Caregiver with mental/behavioral disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caregiver-mediated Intervention in Home-living Chronic Stroke Patients
To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.
Read the detailed description
In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.
- Conditions
- Stroke
- Being tested
- Care-giver mediated training
- Keywords
- Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care-giver mediated trainingOther
A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Care-giver mediated training | Active comparator | Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need. Receives: Other: Care-giver mediated training |
| Standard-care | No intervention | Maintain the inherent standard-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale
Change from baseline in Stroke Impact Scale at 12 weeks
Measured: Baseline and 12 weeks
Secondary outcomes (6)
10-meter walking speed
Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks
Measured: Baseline and 12 weeks
Berg balance scale
Change from baseline in berg balance scale score at 12 weeks
Measured: Baseline and 12 weeks
6-min walking distance
Change from baseline in 6-min walking distance at 12 weeks
Measured: Baseline and 12 weeks
Bathel index score
Change from baseline in Bathel index score at 12 weeks
Measured: Baseline and 12 weeks
Lawton Instrumental Activities of Daily Living scale (IADL)
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
Measured: Baseline and 12 weeks
Fugl-Meyer Assessment Scale
Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Alan. C Tsai, PhD, Study chair, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693341
- Sponsor's protocol ID
- CT-tsaiac1943
- Status last verified
- Jul 2024
- First submitted
- 20 Sep 2012
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.
PubMed 21233462
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver-mediated Intervention in Home-living Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT01693341
- Acronym / sponsor ID
- CT-tsaiac1943
- Conditions
- Stroke
- Keywords
- Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- 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.
To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.
Detailed description
In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care-giver mediated training | Active comparator | Other: Care-giver mediated trainingEach patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need. |
| Standard-care | No intervention | –Maintain the inherent standard-care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
- No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)
Key exclusion criteria (4 listed)
- Recurring strokes
- Mental or cognitive impairment
- Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
- Caregiver with mental/behavioral disorders
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 |
|---|---|---|
| Care-giver mediated trainingA physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks. | Other | Care-giver mediated training |
Primary outcome
Stroke Impact Scale
Time frame: Baseline and 12 weeks
Change from baseline in Stroke Impact Scale at 12 weeks
6 secondary outcomes
10-meter walking speed
Time frame: Baseline and 12 weeks
Berg balance scale
Time frame: Baseline and 12 weeks
6-min walking distance
Time frame: Baseline and 12 weeks
Bathel index score
Time frame: Baseline and 12 weeks
Lawton Instrumental Activities of Daily Living scale (IADL)
Time frame: Baseline and 12 weeks
Fugl-Meyer Assessment Scale
Time frame: Baseline and 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 31 Jul 2024.
- Background: PubMed 21233462Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.
Related trials for Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Acute Ischemic Stroke
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.
Alan. C Tsai, PhD study chair
Asia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care-giver mediated training in people with Stroke, run by Asia University at 1 site in Taiwan.
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 2 inclusion and 4 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 31 Jul 2024. 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 Taiwan. 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?
Stroke Impact Scale (time frame: Baseline and 12 weeks). 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 NCT01693341, 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 31 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.