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?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in Motor Activity Log (MAL)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Motor Activity Log (MAL)
Time Frame: Baseline, 2 weeks, and 4 weeks
The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The summary score is the mean of the item scores. The clinimetric properties of the MAL in stroke patients have been validated.
Change in Stroke Impact Scale Version 3.0 (SIS 3.0)
Time Frame: Baseline, 2 weeks, and 4 weeks
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.
Change in Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, 2 weeks, and 4 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Change in Wolf Motor Function Test (WMFT)
Time Frame: Baseline, 2 weeks, and 4 weeks
The WMFT was originally designed to assess the effects of CIT on the return of arm function for stroke and traumatic brain injury. The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients.
Change in Functional Independence Measure (FIM)
Time Frame: Baseline, 2 weeks, and 4 weeks
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 (maximum score 126) based on the required level of assistance to perform the tasks (e.g., 1-complete assistance and 7-complete independence). A higher score on any subscale indicates a less disability. The FIM has been shown to have good inter-rater reliability, construct validity, and discriminant validity.
Secondary Outcomes
- Change in Urinary 8-hydroxydeoxyguanosine (8-OHdG)(Baseline, 2 weeks, and 4 weeks)
- Change in Revised Nottingham Sensory Assessment (RNSA)(Baseline, 2 weeks, and 4 weeks)
- Change in MyotonPRO(Baseline, 2 weeks, and 4 weeks)
- Change in Medical Research Council scale (MRC)(Baseline, 2 weeks, and 4 weeks)
- Change in Actigraphy(Baseline, 2 weeks, and 4 weeks)
- Change in Kinematic analysis(Baseline, 2 weeks, and 4 weeks)
- Change in Modified Ashworth Scale (MAS)(Baseline, 2 weeks, and 4 weeks)
- Change in Visual analogue scale (VAS) for assessing post-exertional fatigue and pain(From the date of treatment started until the date of treatment ended at 0, 90, 105 minutes for each treatment period)