StrokeSmart-RehabNCT03282734
Home-based Exercise Program With Smart Rehabilitation System
A study testing Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) and Conventional home rehabilitation exercise in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) and Conventional home rehabilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2017to 31 Dec 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult stroke patients (more than 18 years old)
- less than 6 months after stroke onset
- discharged to home or the plan to discharge to home less than 3 days
- independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)
Who cannot join
- Advanced liver, kidney, cardiac, or pulmonary disease
- A terminal medical diagnosis consistent with survival < 1 year)
- Pre-existing and active major neurological disease
- Pre-existing and active major psychiatric disease
- Severe language disorders
- Severe cognitive disorders (10 or less than 10 in K-MMSE)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.
Read the detailed description
The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.
- Conditions
- Stroke
- Being tested
- Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.), Conventional home rehabilitation exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)Other
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks
Conventional home rehabilitation exerciseOther
Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| The smart rehab group | Experimental | Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks Receives: Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) |
| The control group | Active comparator | Conventional home rehabilitation exercise education for 4 weeks Receives: Other: Conventional home rehabilitation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test
Assessment of balance and gait function
Measured: Change from baseline Timed Up and Go test at 4 weeks
Secondary outcomes (6)
Tinetti Performance Oriented Mobility Assessment
Assessment of balance and gait function
Measured: Change from baseline Timed Up and Go test at 4 weeks
Berg Balance scale
Assessment of balance
Measured: Change from baseline Timed Up and Go test at 4 weeks
Korean-Geriatric Depression Scale- Short Form
Assessment of mood
Measured: Change from baseline Timed Up and Go test at 4 weeks
EQ-5D
Assessment of quality of life
Measured: Change from baseline Timed Up and Go test at 4 weeks
Falls Efficacy Scale
Assessment of fall risk
Measured: Change from baseline Timed Up and Go test at 4 weeks
Korean version of Physical Activity Scale for the Elderly
Assessment of physical activity
Measured: Change from baseline Timed Up and Go test at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start18 Sep 2017
- Primary completion30 Jun 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282734
- Sponsor's protocol ID
- 2017-07-072
- Acronym
- Smart-Rehab
- Status last verified
- Mar 2020
- First submitted
- 10 Sep 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT03282734
- Acronym / sponsor ID
- Smart-Rehab / 2017-07-072
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Sep 2017 (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.
A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.
Detailed description
The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The smart rehab group | Experimental | Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks |
| The control group | Active comparator | Other: Conventional home rehabilitation exerciseConventional home rehabilitation exercise education for 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult stroke patients (more than 18 years old)
- less than 6 months after stroke onset
- discharged to home or the plan to discharge to home less than 3 days
- independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)
Key exclusion criteria (6 listed)
- Advanced liver, kidney, cardiac, or pulmonary disease
- A terminal medical diagnosis consistent with survival < 1 year)
- Pre-existing and active major neurological disease
- Pre-existing and active major psychiatric disease
- Severe language 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 |
|---|---|---|
| Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks | Other | The smart rehab group |
| Conventional home rehabilitation exerciseConventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks | Other | The control group |
Primary outcome
Timed Up and Go test
Time frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of balance and gait function
6 secondary outcomes
Tinetti Performance Oriented Mobility Assessment
Time frame: Change from baseline Timed Up and Go test at 4 weeks
Berg Balance scale
Time frame: Change from baseline Timed Up and Go test at 4 weeks
Korean-Geriatric Depression Scale- Short Form
Time frame: Change from baseline Timed Up and Go test at 4 weeks
EQ-5D
Time frame: Change from baseline Timed Up and Go test at 4 weeks
Falls Efficacy Scale
Time frame: Change from baseline Timed Up and Go test at 4 weeks
Korean version of Physical Activity Scale for the Elderly
Time frame: Change from baseline Timed Up and Go test at 4 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 18 Mar 2020.
- Individual participant dataSharing planned: No
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Music Therapy in Post-Stroke Patients: A Clinical Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) and Conventional home rehabilitation exercise in people with Stroke, run by Samsung Medical Center at 1 site in South Korea.
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 6 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 18 Mar 2020. 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 South Korea. 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?
Timed Up and Go test (time frame: Change from baseline Timed Up and Go test at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.