Clinical trial NCT01727648: Effects of RAT in Sequential Combination With CIT in Stroke Rehabilitation
Official title: Effects of Robot-Assisted Therapy in Sequential Combination With Constraint-Induced Therapy in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Stroke rehabilitation
Comparative efficacy research
Combined therapy
Robot-Assisted Therapy
Constraint-Induced Therapy
Kinematic analysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.

Detailed description: The overall goal of this research project will be to provide scientific evidence of the robot-assisted therapy in sequential combination with distributed constraint-induced therapy (RT + dCIT)versus monotherapy of the robot-assisted therapy (RT), distributed constraint-induced therapy (dCIT), and a dose-matched control therapy (DMCT)in stroke rehabilitation. The specific aims of this proposed research are identified as follows:

1. The investigators will investigate the treatment effects of RT + dCIT compared to RT, CIT, and DMCT on motor ability, muscle function, sensory function, daily performance, real-world arm activity, quality of life, and motor control variables at before treatment, midterm assessment, and after treatment. In addition to study of treatment benefits, physiological responses as the potential adverse effects including post-exertional fatigue, post-exertional pain, and a biomarker of oxidative stress will be also examined in this project. The investigators hypothesized that the therapeutic regimen combining RT with dCIT will contribute to more significantly reduction in impairment and disability for stroke patients than the other intervention groups.
2. The investigators will investigate if the clinical characteristics or behavioral markers of stroke patients will influence the outcomes after interventions. The proposed potential predictors will be chronicity, side of lesion, muscle tone, motor ability of distal part of upper limb, and amount of affected hand use.
3. The investigators will examine whether the improved scores after each treatment reach clinically important changes in order to establish the clinical significance relevant for individualized medicine. The investigators will also assess and compare the clinimetric properties (e.g., validity, responsiveness, minimal detectable change, and minimal clinically important difference) of the rehabilitation outcomes to inform selection of instruments.

Eligibility criteria: Inclusion Criteria:

* 6 months onset from a first-ever unilateral stroke
* An initial UL subsection of the Fugl-Meyer Assessment score of 20 to 50 indicating moderate and moderate to severe UL movement impairment
* No balance problems sufficient to compromise safety when wearing the study's constraint device
* No excessive spasticity in any of the joints of the affected UL (modified Ashworth scale ≤ 3)
* Without upper limb fracture within 3 months
* Be able to follow study instructions and perform study tasks (Mini Mental State Examination ≥ 24)
* Willing to provide written informed consent

Exclusion Criteria:

* Exhibit physician-determined major medical problems or poor physical conditions that would interfere with participation
* Excessive pain in any joint that might limit participation

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: An expected average of 4 weeks
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: An expected average of 4 weeks
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: An expected average of 4 weeks
measure: Visual analogue scale (VAS) for assessing post-exertional fatigue and pain
timeFrame: An expected average of 4 weeks
measure: Actigraphy
timeFrame: An expected average of 4 weeks
measure: Motor Status Score (MSS)
timeFrame: An expected average of 4 weeks
measure: Wolf Motor Function Test (WMFT)
timeFrame: An expected average of 4 weeks
measure: Medical Research Council scale (MRC)
timeFrame: An expected average of 4 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: An expected average of 4 weeks
measure: Revised Nottingham Sensory Assessment (RNSA)
timeFrame: An expected average of 4 weeks
measure: Myoton
timeFrame: An expected average of 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsieh YW, Liing RJ, Lin KC, Wu CY, Liou TH, Lin JC, Hung JW. Sequencing bilateral robot-assisted arm therapy and constraint-induced therapy improves reach to press and trunk kinematics in patients with stroke. J Neuroeng Rehabil. 2016 Mar 22;13:31. doi: 10.1186/s12984-016-0138-5.
citation: Hsieh YW, Lin KC, Horng YS, Wu CY, Wu TC, Ku FL. Sequential combination of robot-assisted therapy and constraint-induced therapy in stroke rehabilitation: a randomized controlled trial. J Neurol. 2014 May;261(5):1037-45. doi: 10.1007/s00415-014-7345-4. Epub 2014 Apr 20.