Cerebrovascular AccidentNCT01655160
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
A study testing MT with low-intensity group (MT-LI), MT with moderate-intensity group and Mirror therapy with high intensity group in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- MT with low-intensity group (MT-LI), MT with moderate-intensity group and Mirror therapy with high intensity group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Mar 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first episode of stroke in cortical regions
- time since stroke less than 3 months
- initial motor part of UE of FMA score ranging from 24 to 52
- no serious cognitive impairment
Who cannot join
- aphasia
- visual impairments
- major health problems or poor physical conditions
- currently participation in any other
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.
Read the detailed description
This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.
- Conditions
- Cerebrovascular Accident
- Being tested
- MT with low-intensity group (MT-LI), MT with moderate-intensity group, Mirror therapy with high intensity group, Control intervention group
- Keywords
- Stroke rehabilitation, Mirror therapy, Functional performance, Kinematic analysis, Functional magnetic resonance image, Motor recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT with low-intensity group (MT-LI)Behavioural
Also called MT-LI
The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
MT with moderate-intensity groupBehavioural
Also called MT-MI
The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
Mirror therapy with high intensity groupBehavioural
Also called MT-HI
The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
Control intervention groupBehavioural
Also called CI
The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
| Study group | Role | What they receive |
|---|---|---|
| mirror therapy treatment | Experimental | Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI) Receives: Behavioral: MT with low-intensity group (MT-LI); Behavioral: MT with moderate-intensity group; Behavioral: Mirror therapy with high intensity group |
| control intervention group | Active comparator | The part of this project will involve 1 treatment groups:control intervention group (CI) Receives: Behavioral: Control intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Measured: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
Action Research Arm Test (ARAT)
ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
Measured: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks
Motor Activity Log (MAL)
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.
Measured: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
ABILHAND Questionnaire
ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.
Measured: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
Adelaide Activities Profile (AAP)
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.
Measured: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks
Secondary outcomes (2)
Functional magnetic resonance imaging (fMRI)
uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.
Measured: Baseline and change of fMRI at 4 weeks
Physiological marker measures
measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.
Measured: Baseline and change from baseline in physiological marker measures 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 posted1 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655160
- Sponsor's protocol ID
- 100-4548B
- Status last verified
- Jun 2015
- First submitted
- 30 Jul 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.
- ClinicalTrials.gov ID
- NCT01655160
- Acronym / sponsor ID
- 100-4548B
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke rehabilitation, Mirror therapy, Functional performance, Kinematic analysis, Functional magnetic resonance image, Motor recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Aug 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.
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.
Detailed description
This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirror therapy treatment | Experimental | Behavioral: MT with low-intensity group (MT-LI), Behavioral: MT with moderate-intensity group, Behavioral: Mirror therapy with high intensity groupThree groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI) |
| control intervention group | Active comparator | Behavioral: Control intervention groupThe part of this project will involve 1 treatment groups:control intervention group (CI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first episode of stroke in cortical regions
- time since stroke less than 3 months
- initial motor part of UE of FMA score ranging from 24 to 52
- no serious cognitive impairment
Key exclusion criteria (4 listed)
- aphasia
- visual impairments
- major health problems or poor physical conditions
- currently participation in any other
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 |
|---|---|---|
| MT with low-intensity group (MT-LI)Also: MT-LIThe MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training. | Behavioural | mirror therapy treatment |
| MT with moderate-intensity groupAlso: MT-MIThe MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training. | Behavioural | mirror therapy treatment |
| Mirror therapy with high intensity groupAlso: MT-HIThe MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training | Behavioural | mirror therapy treatment |
| Control intervention groupAlso: CIThe CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training. | Behavioural | control intervention group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
Action Research Arm Test (ARAT)
Time frame: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks
ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
Motor Activity Log (MAL)
Time frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.
ABILHAND Questionnaire
Time frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.
Adelaide Activities Profile (AAP)
Time frame: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.
2 secondary outcomes
Functional magnetic resonance imaging (fMRI)
Time frame: Baseline and change of fMRI at 4 weeks
Physiological marker measures
Time frame: Baseline and change from baseline in physiological marker measures 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 8 Jun 2015.
Related trials for Cerebrovascular Accident
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled 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.
Ching-yi Wu, ScD principal investigator
Chang Gung 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 MT with low-intensity group (MT-LI), MT with moderate-intensity group and Mirror therapy with high intensity group in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital 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 4 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 8 Jun 2015. 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?
Fugl-Meyer Assessment (FMA) (time frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks). The study lists 5 primary outcomes in all. 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 8 Jun 2015.