Clinical trial NCT01907139: Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation
Official title: Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation: Does the Combined Therapy Improve Outcomes Compared With Monotherapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: comparative efficacy research
combination therapy
neurorehabilitation
robot-assisted therapy
constraint-induced therapy
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There are 3 specific study purposes. First, we will examine the treatment effects of RT combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions, amount of arm activity in real-life situations, patient-reported outcomes of daily performance and quality of life, and kinematic performance. Additionally, potential adverse effects including fatigue, pain, and a biomarker of oxidative stress will be examined. Second, we will investigate if the demographical and clinical characteristics of stroke patients may predict the probability of achieving clinically important changes of treatment outcomes. Thirdly, this study will examine whether the improvements after treatment reach clinically important or not and assess clinimetric properties of the outcome measures.

Detailed description: This research project will investigate the efficacy of RT in sequential combination with dCIT relative to the therapies given alone and study the factors relevant to outcomes prediction to inform clinical practice. There will be 3 primary purposes in this comprehensive research:

Ⅰ. We will examine the effects of RT combined with dCIT (RT + dCIT) compared to RT, dCIT, and a dose-matched control therapy (DMCT) in stroke patients. Outcome domains will include motor, sensory, and muscle functions, amount of arm activity in real-life situations, patient-reported outcomes of daily performance and quality of life, and kinematic performance at before treatment, midterm assessment, and after treatment. In addition, potential adverse effects including post-exertional fatigue, post-exertional pain, and a biomarker of oxidative stress will be examined. We 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.

Ⅱ. We will investigate if the demographical and clinical characteristics of stroke patients may significantly predict the probability of achieving clinically significant changes of treatment outcomes. The proposed candidate predictors will be chronicity, side of lesion, muscle tone, finger extension, motor function of distal upper limb (UL), and amount of real-life arm activity.

Ⅲ. We will examine whether the improvements after treatments are clinically important and will assess clinimetric properties of the outcome measures to establish the clinical significance relevant for individualized stroke rehabilitation. We 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 56
* minimal motor criteria to receive CIT (i.e., ≥ 100 wrist extension and ≥ 100 extension at the thumb and any two other digits)
* 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)
* welling to provide written informed consent

Exclusion Criteria:

* 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: Change in Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Wolf Motor Function Test (WMFT)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Functional Independence Measure (FIM)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Motor Activity Log (MAL)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, 2 weeks, and 4 weeks
Secondary outcomes:
measure: Change in Medical Research Council scale (MRC)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Modified Ashworth Scale (MAS)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Revised Nottingham Sensory Assessment (RNSA)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in MyotonPRO
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Actigraphy
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Visual analogue scale (VAS) for assessing post-exertional fatigue and pain
timeFrame: From the date of treatment started until the date of treatment ended at 0, 90, 105 minutes for each treatment period
measure: Change in Urinary 8-hydroxydeoxyguanosine (8-OHdG)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Kinematic analysis
timeFrame: Baseline, 2 weeks, and 4 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Buddhist Tzu Chi General Hospital Taipei Branch
Study officials:
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University, Taiwan
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buddhist Tzu Chi General Hospital Taipei Branch
name: Yi-shiung Horng, PhD
role: PRINCIPAL_INVESTIGATOR
References: