Cerebrovascular AccidentNCT01523925
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
A study testing dCIT, BAT and Functional electrical stimulation in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- dCIT, BAT and Functional electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The onset duration more than 6 months
- An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
- No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
- Considerable nonuse of the affected upper extremity (an AOU score < 2.5 of Motor Activity Log)
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.
About this study
Official title: Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.
Read the detailed description
Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT). CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm. BAT involves repetitive practice of symmetrical bilateral movements on robot. Both are evident to improve motor performance, motor control or daily function in high functioning patients. These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e. only appropriate for high-functioning or mildly motor impaired patients. Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution. Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients. Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery. This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.
- Conditions
- Cerebrovascular Accident
- Being tested
- dCIT, BAT, Control intervention group, Functional electrical stimulation
- Keywords
- Functional electrical therapy, Bilateral arm training, Constraint induced therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCITBehavioural
Also called distributed constraint induced therapy
This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
BATBehavioural
Also called bilateral arm training
The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
Control intervention groupBehavioural
Also called Control intervention
The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
Functional electrical stimulationBehavioural
Also called FES
| Study group | Role | What they receive |
|---|---|---|
| Combined dCIT with FET | Experimental | Combined distributed constraint induced therapy with functional electrical therapy Receives: Behavioral: dCIT; Behavioral: Functional electrical stimulation |
| Combined BAT with FET | Experimental | Combined bilateral arm treatment with functional electrical therapy Receives: Behavioral: BAT; Behavioral: Functional electrical stimulation |
| Control intervention group | Active comparator | Control intervention Receives: Behavioral: Control intervention group |
| dCIT | Experimental | distributed constraint induced therapy Receives: Behavioral: dCIT |
| BAT | Experimental | bilateral arm treatment Receives: Behavioral: BAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement time (MT)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.
Measured: Baseline and change from baseline in MT at 4 weeks
Total displacement (TD)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.
Measured: Baseline and change from baseline in TD at 4 weeks
Percentage of peak velocity (PPV)
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.
Measured: Baseline and change from baseline in PPV at 4 weeks
Secondary outcomes (7)
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
Medical Research Council scale (MRC)
The MRC scale examines the muscle strength of the affected arm and is reliable measurement with score ranged from 0 (no contraction) to 5 (normal power).
Measured: Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
Modified Ashworth Scale (MAS)
The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.
Measured: Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
MYOTON-3
Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
Measured: Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 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
Reintegration of Normal Living Index (RNL)
The RNL is used to measure the satisfaction with community reintegration. It scores on a 4-point ordinal scale, with higher scores indicating a higher level of satisfaction.
Measured: Baseline, change of RNL at 2 weeks, and change of RNL 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 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523925
- Sponsor's protocol ID
- NSC 99-2314-B-182-014-MY3
- Other IDs
- 98-3827B
- Status last verified
- Sep 2014
- First submitted
- 30 Jan 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration
- ClinicalTrials.gov ID
- NCT01523925
- Acronym / sponsor ID
- NSC 99-2314-B-182-014-MY3
- Conditions
- Cerebrovascular Accident
- Keywords
- Functional electrical therapy, Bilateral arm training, Constraint induced therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Feb 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.
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.
Detailed description
Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT). CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm. BAT involves repetitive practice of symmetrical bilateral movements on robot. Both are evident to improve motor performance, motor control or daily function in high functioning patients. These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e. only appropriate for high-functioning or mildly motor impaired patients. Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution. Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients. Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery. This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Combined dCIT with FET | Experimental | Behavioral: dCIT, Behavioral: Functional electrical stimulationCombined distributed constraint induced therapy with functional electrical therapy |
| Combined BAT with FET | Experimental | Behavioral: BAT, Behavioral: Functional electrical stimulationCombined bilateral arm treatment with functional electrical therapy |
| Control intervention group | Active comparator | Behavioral: Control intervention groupControl intervention |
| dCIT | Experimental | Behavioral: dCITdistributed constraint induced therapy |
| BAT | Experimental | Behavioral: BATbilateral arm treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The onset duration more than 6 months
- An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
- No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
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 |
|---|---|---|
| dCITAlso: distributed constraint induced therapyThis dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities. | Behavioural | Combined dCIT with FET, dCIT |
| BATAlso: bilateral arm trainingThe BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks. | Behavioural | BAT, Combined BAT with FET |
| Control intervention groupAlso: Control interventionThe conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities. | Behavioural | Control intervention group |
| Functional electrical stimulationAlso: FES | Behavioural | Combined BAT with FET, Combined dCIT with FET |
Primary outcome
Movement time (MT)
Time frame: Baseline and change from baseline in MT at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.
Total displacement (TD)
Time frame: Baseline and change from baseline in TD at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.
Percentage of peak velocity (PPV)
Time frame: Baseline and change from baseline in PPV at 4 weeks
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.
7 secondary outcomes
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
Medical Research Council scale (MRC)
Time frame: Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
Modified Ashworth Scale (MAS)
Time frame: Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
MYOTON-3
Time frame: Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
Motor Activity Log (MAL)
Time frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks
ABILHAND Questionnaire
Time frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks
Reintegration of Normal Living Index (RNL)
Time frame: Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
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 dCIT, BAT and Functional electrical stimulation 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 6 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: withdrawn, as of the sponsor's last update on 11 Feb 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 was withdrawn before enrolling participants, so there are no results.
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?
Movement time (MT) (time frame: Baseline and change from baseline in MT at 4 weeks). The study lists 3 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 11 Feb 2015.