Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01724164
First received: August 28, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Behavioral: Mirror Therapy
Behavioral: Robotic assisted therapy
Behavioral: Robotic Rehabilitation with PI
Behavioral: Robotic rehabilitation with FES
Behavioral: Conventional Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot- Versus Mirror-Assisted Motor Interventions in Rehabilitating Upper-Limb Motor and Muscle Performance and Daily Functions Poststroke: A Comparative Effectiveness Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Fugl-Meyer Assessment (FMA) [ Time Frame: 2011/8 to 2013/1 (up to 2 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
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).
Other Name: RT
Experimental: 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.
Behavioral: 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.
Other Name: MT
Active Comparator: 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.
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.
Other Names:
  • CR
  • Control Treatment
  • CT
Experimental: 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.
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.
Other Name: RR combined Functional Electrical Stimulation (RR-FES)
Placebo Comparator: 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.
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.
Other Name: RR with Placebo Intervention (RR-PI)

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).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724164

Contacts
Contact: Keh-chung Lin, ScD 886-2-33668180 kehchunglin@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Keh-chung Lin, ScD    886-2-33668180    kehchunglin@ntu.edu.tw   
National Taiwan University Hosipital Recruiting
Taipei, Taiwan, 100
Contact: Keh-chung Lin, ScD    886-2-33668167    kehchunglin@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Keh-chung Lin, ScD School of Occupational Therapy, College of Medicine, National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01724164     History of Changes
Other Study ID Numbers: 201003058R
Study First Received: August 28, 2012
Last Updated: November 8, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014