Effects of RR and MT on Patient With Stroke

NCT01655446 | Unknown

• 1 other identifier: 201012131RB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 the clinical predictors that will potentially influence the functional outcomes after interventions.

Conditions

Cerebrovascular Accident

Keywords

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

Outcome Measures

Primary Outcomes (13)

• Fugl-Meyer Assessment (FMA)

  The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).

  Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks

• Modified Ashworth Scale (MAS)

  The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity. Higher score indicates a more severe hypertonia.

  Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks

• Functional independence measure (FIM)

  The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 based on the required level of assistance to perform the tasks.

  Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks

• Movement units (MU)

  The parameter of movement units 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. One acceleration phase and one deceleration phase constitute a MU. The number of MU indicates the movement smoothness.

  Change from baseline in MU at 4 weeks

• Total displacement (TD)

  The TD 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 shifting in three-dimensional space and is a measurement of trajectory smoothness.

  Change from baseline in TD at 4 weeks

• Percentage of peak velocity (PPV)

  PPV 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. PPV indicates the percentage of acceleration phase among the whole movement process. It is an outcome measurement of pre-motor planning ability.

  Change from baseline in PPV at 4 weeks

• Reaction time (RT)

  The reaction 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. RT is the time required to prepare a motor response toward an external signal and indicates speed of motor planning.

  Change from baseline in RT at 4 weeks

• Action Research Arm Test (ARAT)

  The ARAT assesses the ability to handle objects with 19 items divided into 4 subscales of grasp, grip, pinch, and gross movement by 4-level ordinal scale. Higher the score, better the performance.

  Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks

• Medical Research Council scale (MRC)

  The MRC scale assesses muscle power with scores ranging from 0 (no contraction) to 5 (normal power). The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist flexors/extensors, and finger extensors are graded.

  Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks

• MYOTON-3

  MYOTON-3 is used to assess muscle tone of the affected upper limb. There are three measurement parameters in the MYOTON-3: F - Frequency, Hz, characterizing muscle tone; D - Decrement, characterizing muscle elasticity; and S - Stiffness, N/m, characterizing muscle stiffness.

  Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks

• Accelerometers

  Accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. In this project, acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.

  Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks

• Peak velocity (PV)

  PPV 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. PV corresponds to the changeover from the acceleration to the deceleration phase and is related to the force produced.

  Change from baseline in PV at 4 weeks

• Trunk related Kinematic variables

  The parameter of movement units 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. These parameters include trunk displacement, trunk flexion angular change, trunk-arm delay, shoulder flexion \& trunk flexion correlation, and elbow extension \& trunk flexion correlation. These variables indicate the degree of trunk compensatory movement and interjoint coordination.

  Change from baseline in trunk related kinematic variables at 4 weeks

Secondary Outcomes (8)

• Motor Activity Log (MAL)

  Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks

• ABILHAND Questionnaire

  Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks

• Stroke Impact Scale Version 3.0 (SIS 3.0)

  Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks

• Nottingham Extended Activities of Daily Living Scale (NEADL)

  Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks

• revised Nottingham Sensory Assessment (rNSA)

  Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks

Study Arms (5)

Robotic Rehabilitation with FES

EXPERIMENTAL

Robotic rehabilitation combined Functional Electrical Stimulation (FES)

Behavioral: Robotic rehabilitation with FES

Mirror Therapy

EXPERIMENTAL

Mirror Therapy (MT)

Behavioral: Mirror Therapy

Conventional Rehabilitation

ACTIVE COMPARATOR

Conventional Rehabilitation (CR) mainly focuses on occupational therapy training

Behavioral: Conventional Rehabilitation

Robotic Rehabilitation

EXPERIMENTAL

Robotic Rehabilitation (RR)

Behavioral: Robotic Rehabilitation

Robotic Rehabilitation with PI

PLACEBO COMPARATOR

Robotic rehabilitation with Placebo Intervention (RR-PI)

Behavioral: Robotic Rehabilitation with PI

Interventions

Mirror Therapy 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.

Also known as: MT

Mirror Therapy

Conventional Rehabilitation 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.

Also known as: CR, Control Treatment, CT

Conventional Rehabilitation

Robotic Rehabilitation 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).

Also known as: RR, Robotic Therapy, RT

Robotic Rehabilitation

Robotic rehabilitation with FES BEHAVIORAL

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

Also known as: RR-Functional Electrical Stimulation, RR combined Functional Electrical Stimulation, RR-FES

Robotic Rehabilitation with FES

Robotic Rehabilitation with PI 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.

Also known as: Robotic Rehabilitation-PI, RR with Placebo Intervention, RR-PI

Robotic Rehabilitation with PI

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 26520398 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy; proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Keh-chung Lin, ScD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-chung Lin, ScD

CONTACT

886-2-33668180; kehchunglin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: August 1, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

TW (1)