Cerebrovascular AccidentNCT01656876
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
A study testing Mirror box training, mesh glove stimulation and conventional intervention in people with Cerebrovascular Accident, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Mirror box training, mesh glove stimulation and conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2010to May 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
- No serious attention deficits
- No excessive spasticity in any of the joints of the affected UL exclusion criteria
Who cannot join
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shuang-Ho Hospital, Taipei Medical University
New Taipei City, 23561
About this study
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
Read the detailed description
55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
- Conditions
- Cerebrovascular Accident
- Being tested
- Mirror box training, mesh glove stimulation, conventional intervention
- Keywords
- Comparative effectiveness research, Mirror therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis, Mesh glove, Combined therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror box trainingBehavioural
Also called MT
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
mesh glove stimulationOther
Also called MG
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
conventional interventionBehavioural
Also called CI
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | mirror box training with or without sham mesh glove stimulation Receives: Behavioral: Mirror box training |
| Mirror therapy + Mesh glove stimulation | Experimental | Mirror therapy combined with mesh glove stimulation Receives: Behavioral: Mirror box training; Other: mesh glove stimulation |
| Controlled intervention | Active comparator | conventional interventions Receives: Behavioral: conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
Measured: Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
Wolf Motor Function Test (WMFT)
- The WMFT composed of 3 parts: Time, Functional ability, and Strength
- Includes 15 function-based tasks and 2 strength based tasks
- Performance time is referred to as WMFT-TIME
- Functional ability is referred to as WMFT-FAS
- Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks.
- Examiner should test the less affected upper extremity followed by the most affected side.
- Uses a 6-point ordinal scale
- "0" = "does not attempt with the involved arm" to
- "5" = "arm does participate; movement appears to be normal."
- Maximum score is 75
- Lower scores are indicative of lower functioning levels
- WMFT-TIME allows 120 seconds per task
Measured: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
Accelerometers
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. Acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
Measured: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
revised Nottingham Sensory Assessment (rNSA)
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
Measured: Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
Secondary outcomes (6)
Kinematic analyses
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used. The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
Measured: Baseline, change from baseline in kinematic parameters 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 superior amount and quality of use in affected upper extremity.
Measured: Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
Semmes-Weinstein monofilaments
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
Measured: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
Functional Independence Measure (FIM)
The FIM consists of 18 items grouped into 6 subscales. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.
Measured: Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Stroke Impact Scale version 3.0 (SIS 3.0)
The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains. Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Measured: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
8-OHdG
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions. The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis. A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
Measured: Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
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.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsan-hon Liou, PhD, Principal investigator, Shuang-Ho Hospital, Taipei Medical UniversityChing-yi Wu, ScD, Principal investigator, Department of Occupational Therapy, College of Medicine, Chang Gung UniversityKeh-chung Lin, ScD, Principal investigator, School of Occupational Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656876
- Sponsor's protocol ID
- CRC-09-10-08
- Status last verified
- Nov 2012
- First submitted
- 27 Jul 2012
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
- ClinicalTrials.gov ID
- NCT01656876
- Acronym / sponsor ID
- CRC-09-10-08
- Conditions
- Cerebrovascular Accident
- Keywords
- Comparative effectiveness research, Mirror therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis, Mesh glove, Combined therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 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 is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
Detailed description
55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Behavioral: Mirror box trainingmirror box training with or without sham mesh glove stimulation |
| Mirror therapy + Mesh glove stimulation | Experimental | Behavioral: Mirror box training, Other: mesh glove stimulationMirror therapy combined with mesh glove stimulation |
| Controlled intervention | Active comparator | Behavioral: conventional interventionconventional interventions |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
Key exclusion criteria (2 listed)
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
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 |
|---|---|---|
| Mirror box trainingAlso: MTThis protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror. | Behavioural | Mirror therapy, Mirror therapy + Mesh glove stimulation |
| mesh glove stimulationAlso: MGThe MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes. | Other | Mirror therapy + Mesh glove stimulation |
| conventional interventionAlso: CIParticipants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach | Behavioural | Controlled intervention |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
Wolf Motor Function Test (WMFT)
Time frame: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
* The WMFT composed of 3 parts: Time, Functional ability, and Strength * Includes 15 function-based tasks and 2 strength based tasks * Performance time is referred to as WMFT-TIME * Functional ability is referred to as WMFT-FAS * Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. * Examiner should test the less affected upper extremity followed by the most affected side. * Uses a 6-point ordinal scale * "0" = "does not attempt with the involved arm" to * "5" = "arm does participate; movement appears to be normal." * Maximum score is 75 * Lower scores are indicative of lower functioning levels * WMFT-TIME allows 120 seconds per task
Accelerometers
Time frame: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. Acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
6 secondary outcomes
Kinematic analyses
Time frame: Baseline, change from baseline in kinematic parameters at 4 weeks
Motor Activity Log (MAL)
Time frame: Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
Semmes-Weinstein monofilaments
Time frame: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
Functional Independence Measure (FIM)
Time frame: Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Stroke Impact Scale version 3.0 (SIS 3.0)
Time frame: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
8-OHdG
Time frame: Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 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 5 Nov 2015.
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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.
Tsan-hon Liou, PhD principal investigator
Shuang-Ho Hospital, Taipei Medical University
Ching-yi Wu, ScD principal investigator
Department of Occupational Therapy, College of Medicine, Chang Gung University
Keh-chung Lin, ScD principal investigator
School of Occupational Therapy, College of Medicine, National Taiwan 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 Mirror box training, mesh glove stimulation and conventional intervention in people with Cerebrovascular Accident, run by Taipei Medical University 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 7 inclusion and 2 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 5 Nov 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 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks). The study lists 4 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 5 Nov 2015.