Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatments robot-assisted therapy, distributed constraint-induced therapy, dose-matched control therapy
Sponsor Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Start date August 2013
End date July 2016
Trial size 80 participants
Trial identifier NCT01907139, 01-M07-072

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks.
distributed constraint-induced therapy dCIT
The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping. The shaping techniques will involve individualized task selection, graded task difficulty (e.g., practicing deficient parts of the selected activity and then performing the entire activity), verbal feedback, prompting, physical assistance with movements, and modeling. The level of challenge will be adapted based on patient ability and improvement. Participants will be also required to place their unaffected hand and wrist in a mitt for 6 hours a day during the 4-week period and document mitt compliance in daily logs.
(Experimental)
The ArmeoSpring (Hocoma AG, Switzerland) will be adopted in this study. It is a 5 degree-of-freedom skeleton mechanism that automates arm movement in a gravity-supported and computer-enhanced environment. The design of the arm support component of the ArmeoSpring is based on Wilmington Robotic Exoskeleton, an antigravity arm support. The ArmeoSpring g provides weight support for the arm across a large 3D workspace, enabling naturalistic movement across approximately 66% of the normal workspace in the vertical plane and 72% in the horizontal plane. Its main structure consists of an arm exoskeleton with elastic bands that relieve the weight of the limb and provide a sense of arm flotation at all positions in the available workspace. A custom grip sensor consisting of a water-filled cylindrical bladder detects grip pressure and finger movement and allows incorporation of grasp and release practice into arm training.
robot-assisted therapy RT
Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment. Vu Therapy games were developed with the goal of enabling repetitive task-specific practice including grocery shopping, cleaning a stovetop, and playing basketball. In this way, stroke patients who are unable to use their severely weakened arms in a functional way are able to practice task-specific movements in a simulated, gravity-reduced environment. Auditory and visual feedback is provided throughout game play to maintain the patient's attention and motivation. In addition, users are provided objective feedback of task performance at the end of each game to enhance motivation and awareness of progress.
(Active Comparator)
The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening.
dose-matched control therapy DMCT
The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening. The treatment protocol will include (1) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes, (2) tasks for training fine motor or dexterous function for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected UL for 15 to 20 minutes, and (5) activities of daily living or functional tasks practice for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment and individual needs of the patients.
(Experimental)
In this combination therapy group, the participants will received 2 weeks of RT using the ArmeoSpring and followed by 2 weeks of distributed CIT. The treatment principles of RT and distributed CIT are the same with those described in the monotherapy of RT or dCIT, respectively. This combined intervention group may integrate proximal (shoulder and elbow) to distal (wrist and hand) training of the UL and help transfer from motor ability gained to functional performance improvement. That is, it appears to associate with the advantages/effects of each RT and dCIT intervention.
robot-assisted therapy RT
Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment. Vu Therapy games were developed with the goal of enabling repetitive task-specific practice including grocery shopping, cleaning a stovetop, and playing basketball. In this way, stroke patients who are unable to use their severely weakened arms in a functional way are able to practice task-specific movements in a simulated, gravity-reduced environment. Auditory and visual feedback is provided throughout game play to maintain the patient's attention and motivation. In addition, users are provided objective feedback of task performance at the end of each game to enhance motivation and awareness of progress.
distributed constraint-induced therapy dCIT
The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping. The shaping techniques will involve individualized task selection, graded task difficulty (e.g., practicing deficient parts of the selected activity and then performing the entire activity), verbal feedback, prompting, physical assistance with movements, and modeling. The level of challenge will be adapted based on patient ability and improvement. Participants will be also required to place their unaffected hand and wrist in a mitt for 6 hours a day during the 4-week period and document mitt compliance in daily logs.

Primary Outcomes

Measure
Change in Fugl-Meyer Assessment (FMA)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Wolf Motor Function Test (WMFT)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Functional Independence Measure (FIM)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Motor Activity Log (MAL)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Stroke Impact Scale Version 3.0 (SIS 3.0)
time frame: Baseline, 2 weeks, and 4 weeks

Secondary Outcomes

Measure
Change in Medical Research Council scale (MRC)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Modified Ashworth Scale (MAS)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Revised Nottingham Sensory Assessment (RNSA)
time frame: Baseline, 2 weeks, and 4 weeks
Change in MyotonPRO
time frame: Baseline, 2 weeks, and 4 weeks
Change in Actigraphy
time frame: Baseline, 2 weeks, and 4 weeks
Change in Visual analogue scale (VAS) for assessing post-exertional fatigue and pain
time frame: From the date of treatment started until the date of treatment ended at 0, 90, 105 minutes for each treatment period
Change in Urinary 8-hydroxydeoxyguanosine (8-OHdG)
time frame: Baseline, 2 weeks, and 4 weeks
Change in Kinematic analysis
time frame: Baseline, 2 weeks, and 4 weeks

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

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?
Principal investigator Keh-chung Lin, ScD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.