Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation

NCT ID: NCT01907139

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Distributed constraint-induced therapy

Intervention Type: BEHAVIORAL

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.

Robot-assisted therapy (RT)

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.

Group Type: EXPERIMENTAL

Robot-assisted therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Dose-matched control therapy

Intervention Type: BEHAVIORAL

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.

RT + dCIT

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.

Group Type: EXPERIMENTAL

Robot-assisted therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

Robot-assisted therapy

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.

Intervention Type: BEHAVIORAL

Distributed constraint-induced therapy

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.

Intervention Type: BEHAVIORAL

Dose-matched control therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

RT; dCIT; DMCT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

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

Yi-shiung Horng, PhD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital Taipei Branch

Locations

Buddhist Tzu Chi General Hospital Taipei Branch

New Taipei City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

01-M07-072

Identifier Type: -

Identifier Source: org_study_id