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Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients

NCT ID: NCT01724164

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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

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Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic assisted therapy

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).

Group Type EXPERIMENTAL

Robotic assisted therapy

Intervention Type BEHAVIORAL

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).

Mirror Therapy

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.

Group Type EXPERIMENTAL

Mirror Therapy

Intervention Type BEHAVIORAL

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.

Conventional Rehabilitation

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.

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type BEHAVIORAL

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.

Robotic rehabilitation with FES

This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.

Group Type EXPERIMENTAL

Robotic rehabilitation with FES

Intervention Type BEHAVIORAL

This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.

Robotic Rehabilitation with 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.

Group Type PLACEBO_COMPARATOR

Robotic Rehabilitation with PI

Intervention Type BEHAVIORAL

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.

Interventions

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Mirror Therapy

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.

Intervention Type BEHAVIORAL

Robotic assisted therapy

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).

Intervention Type BEHAVIORAL

Robotic Rehabilitation with 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.

Intervention Type BEHAVIORAL

Robotic rehabilitation with FES

This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.

Intervention Type BEHAVIORAL

Conventional Rehabilitation

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MT RT RR with Placebo Intervention (RR-PI) RR combined Functional Electrical Stimulation (RR-FES) CR Control Treatment CT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

School of Occupational Therapy, College of Medicine, National Taiwan University

Locations

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National Taiwan University Hosipital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Keh-chung Lin, ScD

Role: CONTACT

Phone: 886-2-33668180

Email: [email protected]

Facility Contacts

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Keh-chung Lin, ScD

Role: primary

Keh-chung Lin, ScD

Role: primary

Other Identifiers

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201003058R

Identifier Type: -

Identifier Source: org_study_id