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Effects of RR and MT on Patient With Stroke

NCT ID: NCT01655446

Last Updated: 2012-08-01

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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Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Conditions

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Cerebrovascular Accident

Keywords

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Comparative effectiveness research Robotic rehabilitation Mirror therapy Functional electrical therapy Combined therapy Stroke rehabilitation Translational science

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic Rehabilitation with FES

Robotic rehabilitation combined Functional Electrical Stimulation (FES)

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.

Mirror Therapy

Mirror Therapy (MT)

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

Conventional Rehabilitation (CR) mainly focuses on occupational therapy training

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

Robotic Rehabilitation (RR)

Group Type EXPERIMENTAL

Robotic Rehabilitation

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).

Robotic Rehabilitation with PI

Robotic rehabilitation with Placebo Intervention (RR-PI)

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 UL 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

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

Robotic Rehabilitation

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 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

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 UL but there is no output of electrical stimulation.

Intervention Type BEHAVIORAL

Other Intervention Names

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MT CR Control Treatment CT RR Robotic Therapy RT RR-Functional Electrical Stimulation RR combined Functional Electrical Stimulation RR-FES Robotic Rehabilitation-PI RR with Placebo Intervention RR-PI

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 UE subtest of the 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
* Occurence 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 Hospital

Taipei, , 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

References

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Lee YY, Lin KC, Cheng HJ, Wu CY, Hsieh YW, Chen CK. Effects of combining robot-assisted therapy with neuromuscular electrical stimulation on motor impairment, motor and daily function, and quality of life in patients with chronic stroke: a double-blinded randomized controlled trial. J Neuroeng Rehabil. 2015 Oct 31;12:96. doi: 10.1186/s12984-015-0088-3.

Reference Type DERIVED
PMID: 26520398 (View on PubMed)

Other Identifiers

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201012131RB

Identifier Type: -

Identifier Source: org_study_id