Cerebrovascular AccidentNCT01724164
Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients
A study testing Mirror Therapy, Robotic assisted therapy and Robotic Rehabilitation with PI in people with Cerebrovascular Accident, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Mirror Therapy, Robotic assisted therapy and Robotic Rehabilitation with PI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2011to Jul 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide the written informed consent
- More than 6 months onset of unilateral stroke
- An initial 25-56 or 18-50 scores on the upper limb subtest of the Fugl-Meyer assessment (FMA)
- Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
- Without upper limb fracture within 3 months
Who cannot join
- Recurrent of stroke or seizure episode during the intervention
- Occurrence of serious or continuous pain on affected upper-extremity
- History of other neurological disease or severe orthopaedic condition
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hosipital
Taipei, Taiwan, 100
Keh-chung Lin, ScD, 886-2-33668167, kehchunglin@ntu.edu.tw
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Keh-chung Lin, ScD, 886-2-33668180, kehchunglin@ntu.edu.tw
About this study
Official title: Robot- Versus Mirror-Assisted Motor Interventions in Rehabilitating Upper-Limb Motor and Muscle Performance and Daily Functions Poststroke: A Comparative Effectiveness Study
The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.
Read the detailed description
Emerging stroke rehabilitation therapies have shown promise for improving motor recovery after stroke and involve elements of high-intensity and repetitive task-specific practice, which might be the essential elements of treatment success. Two prominent examples of advances in innovative rehabilitation therapies after stroke include robotic rehabilitation (RR) and mirror therapy (MT). Based on the development of mechanical and biomedical engineering, RR has emerged that incorporates therapeutic elements for success in motor rehabilitation: high-intensity, repetitiveness, task-specificity, feedback, and bilateral training into its design. MT has been proposed in the light of translational research of mirror neurons. In MT, patients place a mirror beside the unaffected limb to block their view of the affected limb, creating the illusion that both limbs are intact. The motor visual input from MT facilitates the activations in the premotor, primary motor and somatosensory areas, which enhance sensory, perception and motor abilities. The MT may be used to restore sensory functions, improve grip/grasp strength and motor function. In addition, an innovative technology, functional electrical stimulation (FES), is proposed as an adjunct to assist in movement execution and increase the electric activity of muscles for movement and the active range of motion in patients with low functioning. Robotic rehabilitation that emphasizes muscle strengthening and motor restoration may be implemented in combination with the FES to improve treatment outcomes in stroke patients with moderate-to-severe motor impairments in movement performance and functional outcomes. Despite these promises, research studies that investigate comparative efficacy of the rival therapies and the effects of combined therapy relative to mono-therapy are lacking. An additional gap in contemporary neurorehabilitation is the lack of sufficient information on the threshold values of clinically significant change in a variety of functional domains relevant for individualized medicine. In addition, research on the potential vales of biomarkers (eg, level of oxidative stress) for use in outcomes study in intense rehabilitation falls far behind disciplines of basic sciences. This proposed research project will be devoted to comparative efficacy trials and clinimetric study to promote evidence-based neurorehabilitation and translational research in stroke.
It has been called for comparative effectiveness research of the innovative treatments to promote evidence-based practice and translational science in stroke motor rehabilitation. Scientific evidence for comparative effectiveness research of RR versus MT on functional outcomes (e.g., motor, muscle, sensory, and daily functions) and adverse physiological responses (e.g., fatigue and oxidative responses) in stroke patients is limited. More rigorous studies are needed to compare the efficacy of RR and MT with control intervention (CI), to identify the predictors of treatment success, and to study change in functions (motor, muscle, sensory, and daily) and level of fatigue and oxidative stress after intense training in order to promote translational science in movement therapy. Therefore, this comparative efficacy research aims at performing a randomized controlled trial (RCT) to (1) verify the efficacy and motor control mechanisms of dose-matched RR, MT, and CI; (2) examine whether RR combined with FES will enhance the effect of RR; (3) study the predictors of treatment outcomes and clinimetric properties of the outcome measures. We hypothesize the RR and MT groups would produce better performance in motor control, muscle function, sensory function, daily functions, and quality of life than the CI group. We further hypothesize that there will be a differential improvements in movement performance and sensory functions between the RR and MT. Combined therapy of the RR and FES (RR-FES) will enhance the effect of RR as compared with the RR plus placebo intervention (RR-PI).
- Conditions
- Cerebrovascular Accident
- Being tested
- Mirror Therapy, Robotic assisted therapy, Robotic Rehabilitation with PI, Robotic rehabilitation with FES, Conventional Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyBehavioural
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 mirror visual feedback reflected by the unaffected upper extremity.
Robotic assisted therapyBehavioural
Also called RT
This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
Robotic Rehabilitation with PIBehavioural
Also called RR with Placebo Intervention (RR-PI)
The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
Robotic rehabilitation with FESBehavioural
Also called RR combined Functional Electrical Stimulation (RR-FES)
This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
Conventional RehabilitationBehavioural
Also called CR, Control Treatment, CT
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted therapy | Experimental | This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany). Receives: Behavioral: Robotic assisted therapy |
| Mirror Therapy | Experimental | 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 mirror visual feedback reflected by the unaffected upper extremity. Receives: Behavioral: Mirror Therapy |
| Conventional Rehabilitation | Active comparator | Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups. Receives: Behavioral: Conventional Rehabilitation |
| Robotic rehabilitation with FES | Experimental | This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR. Receives: Behavioral: Robotic rehabilitation with FES |
| Robotic Rehabilitation with PI | Placebo comparator | The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation. Receives: Behavioral: Robotic Rehabilitation with PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Measured: 2011/8 to 2013/1 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2014 (estimated)
- Study completionJul 2014 (estimated)
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 National Taiwan University 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keh-chung Lin, ScD, Principal investigator, School of Occupational Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724164
- Sponsor's protocol ID
- 201003058R
- Status last verified
- Nov 2012
- First submitted
- 28 Aug 2012
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot- Versus Mirror-Assisted Motor Interventions in Rehabilitating Upper-Limb Motor and Muscle Performance and Daily Functions Poststroke: A Comparative Effectiveness Study
- ClinicalTrials.gov ID
- NCT01724164
- Acronym / sponsor ID
- 201003058R
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 9 Nov 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 proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.
Detailed description
Emerging stroke rehabilitation therapies have shown promise for improving motor recovery after stroke and involve elements of high-intensity and repetitive task-specific practice, which might be the essential elements of treatment success. Two prominent examples of advances in innovative rehabilitation therapies after stroke include robotic rehabilitation (RR) and mirror therapy (MT). Based on the development of mechanical and biomedical engineering, RR has emerged that incorporates therapeutic elements for success in motor rehabilitation: high-intensity, repetitiveness, task-specificity, feedback, and bilateral training into its design. MT has been proposed in the light of translational research of mirror neurons. In MT, patients place a mirror beside the unaffected limb to block their view of the affected limb, creating the illusion that both limbs are intact. The motor visual input from MT facilitates the activations in the premotor, primary motor and somatosensory areas, which enhance sensory, perception and motor abilities. The MT may be used to restore sensory functions, improve grip/grasp strength and motor function. In addition, an innovative technology, functional electrical stimulation (FES), is proposed as an adjunct to assist in movement execution and increase the electric activity of muscles for movement and the active range of motion in patients with low functioning. Robotic rehabilitation that emphasizes muscle strengthening and motor restoration may be implemented in combination with the FES to improve treatment outcomes in stroke patients with moderate-to-severe motor impairments in movement performance and functional outcomes. Despite these promises, research studies that investigate comparative efficacy of the rival therapies and the effects of combined therapy relative to mono-therapy are lacking. An additional gap in contemporary neurorehabilitation is the lack of sufficient information on the threshold values of clinically significant change in a variety of functional domains relevant for individualized medicine. In addition, research on the potential vales of biomarkers (eg, level of oxidative stress) for use in outcomes study in intense rehabilitation falls far behind disciplines of basic sciences. This proposed research project will be devoted to comparative efficacy trials and clinimetric study to promote evidence-based neurorehabilitation and translational research in stroke.
It has been called for comparative effectiveness research of the innovative treatments to promote evidence-based practice and translational science in stroke motor rehabilitation. Scientific evidence for comparative effectiveness research of RR versus MT on functional outcomes (e.g., motor, muscle, sensory, and daily functions) and adverse physiological responses (e.g., fatigue and oxidative responses) in stroke patients is limited. More rigorous studies are needed to compare the efficacy of RR and MT with control intervention (CI), to identify the predictors of treatment success, and to study change in functions (motor, muscle, sensory, and daily) and level of fatigue and oxidative stress after intense training in order to promote translational science in movement therapy. Therefore, this comparative efficacy research aims at performing a randomized controlled trial (RCT) to (1) verify the efficacy and motor control mechanisms of dose-matched RR, MT, and CI; (2) examine whether RR combined with FES will enhance the effect of RR; (3) study the predictors of treatment outcomes and clinimetric properties of the outcome measures. We hypothesize the RR and MT groups would produce better performance in motor control, muscle function, sensory function, daily functions, and quality of life than the CI group. We further hypothesize that there will be a differential improvements in movement performance and sensory functions between the RR and MT. Combined therapy of the RR and FES (RR-FES) will enhance the effect of RR as compared with the RR plus placebo intervention (RR-PI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted therapy | Experimental | Behavioral: Robotic assisted therapyThis protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany). |
| Mirror Therapy | Experimental | Behavioral: Mirror TherapyThis 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 mirror visual feedback reflected by the unaffected upper extremity. |
| Conventional Rehabilitation | Active comparator | Behavioral: Conventional RehabilitationParticipants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups. |
| Robotic rehabilitation with FES | Experimental | Behavioral: Robotic rehabilitation with FESThis combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR. |
| Robotic Rehabilitation with PI | Placebo comparator | Behavioral: Robotic Rehabilitation with PIThe RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to provide the written informed consent
- More than 6 months onset of unilateral stroke
- An initial 25-56 or 18-50 scores on the upper limb subtest of the Fugl-Meyer assessment (FMA)
- Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
- Without upper limb fracture within 3 months
Key exclusion criteria (3 listed)
- Recurrent of stroke or seizure episode during the intervention
- Occurrence of serious or continuous pain on affected upper-extremity
- History of other neurological disease or severe orthopaedic condition
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 TherapyAlso: 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 mirror visual feedback reflected by the unaffected upper extremity. | Behavioural | Mirror Therapy |
| Robotic assisted therapyAlso: RTThis protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany). | Behavioural | Robotic assisted therapy |
| Robotic Rehabilitation with PIAlso: RR with Placebo Intervention (RR-PI)The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation. | Behavioural | Robotic Rehabilitation with PI |
| Robotic rehabilitation with FESAlso: RR combined Functional Electrical Stimulation (RR-FES)This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR. | Behavioural | Robotic rehabilitation with FES |
| Conventional RehabilitationAlso: CR, Control Treatment, CTParticipants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups. | Behavioural | Conventional Rehabilitation |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: 2011/8 to 2013/1 (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
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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.
Keh-chung Lin, ScD principal investigator
School of Occupational Therapy, College of Medicine, National Taiwan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy, Robotic assisted therapy and Robotic Rehabilitation with PI in people with Cerebrovascular Accident, run by National Taiwan University Hospital at 2 sites 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keh-chung Lin, ScD (886-2-33668180, kehchunglin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: 2011/8 to 2013/1 (up to 2 years)). 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 9 Nov 2012.