StrokeRTNCT01767480
Effects of Intensive Robot-assisted Therapy in Patients With Subacute Stroke
A study testing RT and Conventional rehabilitation (CR) in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- RT and Conventional rehabilitation (CR)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first episode of unilateral stroke
- time since stroke less than 3 months, i.e., acute or subacute stage
- initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment
- no serious cognitive impairment (i.e., Mini Mental State Exam score > 23)
Who cannot join
- pregnant or breastfeeding women
- aphasia that might interfere with understanding instructions
- major health problems or poor physical conditions that might limit participation
- currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Mechanisms of Intensive Robot-Assisted Therapy in Patients With Subacute Stroke: Outcomes in Brain/Movement Reorganization, Sensorimotor and Daily Functions, and Physiological Markers.
Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.
This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.
Read the detailed description
Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 3 groups: RT with higher-intensity group, RT with lower-intensity group, and conventional intervention group. Assessments on sensorimotor impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton, Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40 minutes to complete. Evaluation of brain reorganization using functional magnetic resonance image and movement patterns by kinematic analysis take about 1 hour for each examination. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability) before and after intervention. Total 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive.
- Conditions
- Stroke
- Being tested
- RT, Conventional rehabilitation (CR)
- Keywords
- Intensive Robot Assisted Therapy, Subacute Stroke, Brain Reorganization, Sensory Motor, Physiological Marker
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTDevice
Also called Bi-Manu-Track, Reha-Stim Co., Berlin, Germany
The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.
Conventional rehabilitation (CR)Behavioural
Also called CR
CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.
| Study group | Role | What they receive |
|---|---|---|
| Higher-intensity RT group | Experimental | All participants received a duration-matched intervention for 90-120 minutes/day, 5 days/week for 4 consecutive weeks. For the RT groups, they will receive RT training together with functional rehabilitation trainings. Within 1 training session, each patient in the higher-intensity RT group will use Bi-Manual-Tract to practice 400-600 repetitions of the mode 1 and 800-1000 repetitions of mode 2, totaling 1200-1600 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 100-200 repetitions in mode 3, if application. Receives: Device: RT; Behavioral: Conventional rehabilitation (CR) |
| Lower-intensity RT group | Experimental | Patients in the lower-intensity RT received half the number of the repetitions per unit of time than patients in the higher-intensity RT group. Within 1 training session, patients in the lower-intensity RT group will practice 200-300 repetitions of the mode 1 and 400-500 repetitions of mode 2, totaling 600-800 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 50-100 repetitions in mode 3, if application. Receives: Device: RT; Behavioral: Conventional rehabilitation (CR) |
| Conventional rehabilitation (CR) group | Active comparator | The CR group will be designed to control for the duration of therapeutic activities. CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice. Receives: Behavioral: Conventional rehabilitation (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The upper limb part of FMA will be used to evaluate sensorimotor impairment. The motor part consists of 33 items for the reflexes and movement of shoulder, elbow, forearm, wrist, hand, and coordination/speed. The non-motor part consists of 30 items for sensation, passive joint motion, and joint pain of the upper limb. Each item is scored on a scale of 0-2 with a maximum of 66 for motor part and 60 for non-motor (sensory) part. Higher score indicates better sensorimotor function of upper limb.
Measured: At baseline and immediately after the completion of intervention
Motor Status Scale (MSS)
The MSS will be used to identify and quantify change of motor function of upper limb after stroke. This scale isolates and grades movement of the shoulder, elbow, forearm, and wrist using a 6-point scale (0, -1, 1, +1, -2, 2), ranging from no volitional movement to faultless movement. Scoring for the hand is based on a 3-point scale (0-2). It consists of 2 subscales including shoulder/elbow scale and wrist/finger scale. The subscale of shoulder/elbow scale consists of the sum of measures of 12 shoulder movements and 5 elbow/forearm movements (maximum score = 40). The subscale of wrist/finger consists of the sum for 3 wrist and 15 hand movements and 3 hand-based functional tasks (maximal score = 42).
Measured: At baseline and immediately after the completion of intervention
Modified Ashworth Scale (MAS)
The MAS is the most frequently used clinical rating scale to measure muscle spasticity. This measure involves manually moving a limb through the range of motion (ROM) to passively stretch specific muscle groups. The grades of spasticity in MAS are as follows: 0=No increase in muscle tone; 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is(are) moved in flexion or extension; 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3=Considerable increase in muscle tone, passive movement difficult; 4=Affected part(s) rigid in flexion or extension.
Measured: At baseline and immediately after the completion of intervention
MyotonPRO
The Myoton is a hand-held device measure of three mechanical properties of muscle: tone, stiffness and elasticity. Three measurement parameters in the Myoton: F - Frequency, Hz, characterizes muscle tone; D - Decrement, characterizes muscle elasticity; S - Stiffness, N/m, characterizes muscle stiffness. There have been several prototypes of Myoton. Present study will use MyotonPRO; the basic principle is the same in all prototypes but the MyotonPRO has several updates such as a triaxial accelerometer. Comparing with the single axis accelerometer in the earlier prototypes, MyotonPRO makes it more feasible for application.
Measured: At baseline and immediately after the completion of intervention
Muscle metabolism (NIRS)
Muscle metabolic dysfunction will be measured by the near-infrared ray spectroscopy (NIRS). The NIRS will be applied to both the affected and the unaffected arms. The NIRS sensor will be fixed on the targeted muscle of one of the forearms and a cuff is placed on the upper arm of the same side. The artery occlusion will be applied by inflating the cuff to a pressure of at least 60 to 80 above systolic pressure to block both venous outflow and artery inflow. The artery occlusion will last approximate 30 seconds then the cuff pressure is released. The decrease rate of oxyhemoglobin and the increase rate of deoxyhemoglobin during artery occlusion can reflect muscle's anaerobic metabolism during vasoconstriction. The hyperaemic response of the muscle during recovery phase can be characterized by reoxygenation rate and recovery time.
Measured: At baseline and immediately after the completion of intervention
Box and Block Test (BBT)
The BBT will be used as a test of manual dexterity. There are 150 blocks in a test box. When testing begins, the subject should grasp one block at a time with dominant hand, transport the block over the partition, and release it into the opposite compartment. Instruction of this test is "I want to see how quickly you can pick up one block at a time with your right (or left) hand [point to the hand]. Carry it to the other side of the box and drop it. Make sure your fingertips cross the partition." The testing time is one minute. Then, the procedure will be repeated with the nondominant hand. After testing, the examiner should count the blocks. The score is the number of blocks carried from one compartment to the other in one minute. Score for each hand will be separately calculated.
Measured: At baseline and immediately after the completion of intervention
Revised Nottingham Sensory Assessment (RNSA)
The changes on somatosensory function will be determined by the RNSA. This is a standardized tool with good reliability to measure sensory function in the stroke population.The RNSA includes 3 major types of sensation: tactile sensation, proprioception, and stereognostic sense. For the purpose of this study, the regions of upper limb will be selected to be assessed.
Measured: At baseline and immediately after the completion of intervention
Functional Independence Measure (FIM)
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 low score on any subscale indicates a more severe disability.
Measured: At baseline and immediately after the completion of intervention
Motor Activity Log (MAL)
The MAL will be used to capture the level of use of affected upper limb in daily living. The MAL is a semi-structured interview assessing the amount of use (AOU) and quality of movement (QOM) of the affected arm in 30 main daily activities. It scores 0-5 for each activity. Higher score means better performance of the affected arm.
Measured: At baseline, immediately after the completion of intervention, at a 6-month follow up
ABILHAND Questionnaire
The ABILHAND Questionnaire will be used to evaluate the ability of upper limb in bimanual activities. There are 23 bimanual activities to measure subjectively perceived difficulty of patients in performing some common activities in daily living, such as buttoning, cutting nails, and opening a bottle. It scores on a scale of 0-3 (0-cannot perform, 1-performs partially or with great difficulty, 2-performs with some difficulty, 3-performs fully). Its reliability and construct validity has been confirmed.
Measured: At baseline, immediately after the completion of intervention, at a 6-month follow up
Adelaide Activities Profile (AAP)
The AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities. It scores on a scale of 0-3, with higher score indicating more frequent participation.
Measured: At baseline, immediately after the completion of intervention, at a 6-month follow up
EQ-5D-5L
The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
Measured: At baseline and immediately after the completion of intervention
Accelerometers
The activity monitors (i.e. accelerometers) will be used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. This measure, quantitatively recording the amount of activity in free-living conditions, will be used to reflect increase in the amount of affected arm use over time. The participants will be asked to wear an accelerometer on each arm for 3 consecutive days to measure what they actually do. The accelerometers to be used will be wireless plastic units about the size and weight of a large wristwatch that will be worn proximal to the wrist on terrycloth bands.
Measured: At baseline, immediately after the completion of intervention, at a 6-month follow-up.
Functional magnetic resonance imaging (fMRI)
Participants will receive fMRI scanning before and after the intervention on a 3T clinical MRI scanner at Chang Gung Memorial Hospital in Linkou. During the scanning sessions, the head and the unaffected hand of the participants will be restrained and stabilized in a head coil and by a customized splint mask and a wooden apparatus with straps, respectively. Both of their upper limbs will be posited by their torsos. During the two sessions of examination, the relative activity time courses of the blood oxygenation level-dependent (BOLD) response will be collected for further analysis.
Measured: At baseline and immediately after the completion of intervention
Kinematic analysis
The kinematic analysis will involve unilateral and bilateral tasks, in which the participants will be asked to perform by using the affected upper limb or both upper limb simultaneously. A motion analysis system with 7 cameras (VICON MX 30d, Oxford Metrics Inc., Oxford, UK) will be used to capture the motion of arm (s) in kinematic testing. The markers will be attached on the styloid processes of the ulna. Depending on the unilateral or bilateral tasks, the makers will be placed on the affected arm or the both arms, respectively.
Measured: At baseline and immediately after the completion of intervention
Inflammatory markers
Proinflammatory markers and anti-inflammatory markers will be used to reflect the changes on inflammation. Proinflammatory markers include C-reactive protein, tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6, soluble intercellular adhesion molecule (sICAM), and matrix metalloproteinase 9 (MMP 9). Anti-inflammatory markers include IL-10 and IL-1 receptor antagonist.
Measured: At baseline and immediately after the completion of intervention
Oxidative stress markers
Oxidative stress markers and antioxidative markers will be used to reflect the changes on oxidative stress. Oxidative stress makers include malondialdehyde (MDA), 8-Hydroxy-2-deoxyguanosine (8-OHdG), and immunoglobulin G (IgG), whereas antioxidants include superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase.
Measured: At baseline and immediately after the completion of intervention
Erythrocyte deformability
The Elongation Index (EI) will be used to determine the red blood cell deformability, which is based on an isointensity curve in the diffraction pattern by using an ellipse-fitting program. EI is calculated by (L-W)/(L+W), where L and W are the major and minor axes of the ellipse, respectively. The deformability index (δ) is defined as the ratio of the major to the minor axis length (L/W).
Measured: At baseline and immediately after the completion of intervention
Blood glucose indicators
To investigate the relationships between blood glucose levels and functional outcomes, we will also test the level of glucose and HbA1C for the participants before and after rehabilitation intervention.
Measured: At baseline and immediately after the completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767480
- Sponsor's protocol ID
- 101-3905A3
- Acronym
- RT
- Status last verified
- Jul 2015
- First submitted
- 11 Jan 2013
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
PubMed 34695300
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Intensive Robot-Assisted Therapy in Patients With Subacute Stroke: Outcomes in Brain/Movement Reorganization, Sensorimotor and Daily Functions, and Physiological Markers.
- ClinicalTrials.gov ID
- NCT01767480
- Acronym / sponsor ID
- RT / 101-3905A3
- Conditions
- Stroke
- Keywords
- Intensive Robot Assisted Therapy, Subacute Stroke, Brain Reorganization, Sensory Motor, Physiological Marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robot-assisted training (RT) devices developed to date have a significant impact on stroke rehabilitation. Several research groups have developed the robotic devices and examined their efficacy on improving upper limb function after stroke. All these robotic devices have been applied in stroke rehabilitation and their efficacy are evaluated, but the scientific evidence for the mechanisms of RT-induced recovery, the optimal treatment intensity, and the impact on physiological responses is still lacking.
This trial is to examine (1) the immediate effects of treatment intensity in RT on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in RT by conducting a 6-month follow up evaluation; and (3) the effects of RT on cortical/movement reorganization as well as on the physiological markers of inflammation, oxidative stress, and erythrocyte deformability. These overall findings will help better understanding of the efficacy of RT on functional outcomes, brain and movement reorganization, and physiological markers.
Detailed description
Subacute stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 3 groups: RT with higher-intensity group, RT with lower-intensity group, and conventional intervention group. Assessments on sensorimotor impairments (Fugl Mayer Assessment, Motor Status Scale, Modified Ashworth Scale, Myoton, Muscle Metabolism, Box and Block Test, and Revised Nottingham Sensory assessment) and functional performance (Functional Independence Measure, Motor Activity Log, ABILHAND Questionnaire, Adelaide Activities Profile, EQ-5D-5L, and accelerometer) take about 40 minutes to complete. Evaluation of brain reorganization using functional magnetic resonance image and movement patterns by kinematic analysis take about 1 hour for each examination. Blood samples of the patients (12 ml.) will be collected to examine the physiological markers (ie, inflammation-related markers, oxidative stress markers, and erythrocyte deformability) before and after intervention. Total 24 ml blood will be collected in this study. Except for the blood taking, all the examinations are non-invasive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Higher-intensity RT group | Experimental | Device: RT, Behavioral: Conventional rehabilitation (CR)All participants received a duration-matched intervention for 90-120 minutes/day, 5 days/week for 4 consecutive weeks. For the RT groups, they will receive RT training together with functional rehabilitation trainings. Within 1 training session, each patient in the higher-intensity RT group will use Bi-Manual-Tract to practice 400-600 repetitions of the mode 1 and 800-1000 repetitions of mode 2, totaling 1200-1600 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 100-200 repetitions in mode 3, if application. |
| Lower-intensity RT group | Experimental | Device: RT, Behavioral: Conventional rehabilitation (CR)Patients in the lower-intensity RT received half the number of the repetitions per unit of time than patients in the higher-intensity RT group. Within 1 training session, patients in the lower-intensity RT group will practice 200-300 repetitions of the mode 1 and 400-500 repetitions of mode 2, totaling 600-800 repetitions, respectively for the forearm and the wrist movements. In addition, the patients will practice 50-100 repetitions in mode 3, if application. |
| Conventional rehabilitation (CR) group | Active comparator | Behavioral: Conventional rehabilitation (CR)The CR group will be designed to control for the duration of therapeutic activities. CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first episode of unilateral stroke
- time since stroke less than 3 months, i.e., acute or subacute stage
- initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment
- no serious cognitive impairment (i.e., Mini Mental State Exam score > 23)
Key exclusion criteria (4 listed)
- pregnant or breastfeeding women
- aphasia that might interfere with understanding instructions
- major health problems or poor physical conditions that might limit participation
- currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTAlso: Bi-Manu-Track, Reha-Stim Co., Berlin, GermanyThe Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions. | Device | Higher-intensity RT group, Lower-intensity RT group |
| Conventional rehabilitation (CR)Also: CRCR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice. | Behavioural | Conventional rehabilitation (CR) group, Higher-intensity RT group, Lower-intensity RT group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: At baseline and immediately after the completion of intervention
The upper limb part of FMA will be used to evaluate sensorimotor impairment. The motor part consists of 33 items for the reflexes and movement of shoulder, elbow, forearm, wrist, hand, and coordination/speed. The non-motor part consists of 30 items for sensation, passive joint motion, and joint pain of the upper limb. Each item is scored on a scale of 0-2 with a maximum of 66 for motor part and 60 for non-motor (sensory) part. Higher score indicates better sensorimotor function of upper limb.
Motor Status Scale (MSS)
Time frame: At baseline and immediately after the completion of intervention
The MSS will be used to identify and quantify change of motor function of upper limb after stroke. This scale isolates and grades movement of the shoulder, elbow, forearm, and wrist using a 6-point scale (0, -1, 1, +1, -2, 2), ranging from no volitional movement to faultless movement. Scoring for the hand is based on a 3-point scale (0-2). It consists of 2 subscales including shoulder/elbow scale and wrist/finger scale. The subscale of shoulder/elbow scale consists of the sum of measures of 12 shoulder movements and 5 elbow/forearm movements (maximum score = 40). The subscale of wrist/finger consists of the sum for 3 wrist and 15 hand movements and 3 hand-based functional tasks (maximal score = 42).
Modified Ashworth Scale (MAS)
Time frame: At baseline and immediately after the completion of intervention
The MAS is the most frequently used clinical rating scale to measure muscle spasticity. This measure involves manually moving a limb through the range of motion (ROM) to passively stretch specific muscle groups. The grades of spasticity in MAS are as follows: 0=No increase in muscle tone; 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is(are) moved in flexion or extension; 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3=Considerable increase in muscle tone, passive movement difficult; 4=Affected part(s) rigid in flexion or extension.
MyotonPRO
Time frame: At baseline and immediately after the completion of intervention
The Myoton is a hand-held device measure of three mechanical properties of muscle: tone, stiffness and elasticity. Three measurement parameters in the Myoton: F - Frequency, Hz, characterizes muscle tone; D - Decrement, characterizes muscle elasticity; S - Stiffness, N/m, characterizes muscle stiffness. There have been several prototypes of Myoton. Present study will use MyotonPRO; the basic principle is the same in all prototypes but the MyotonPRO has several updates such as a triaxial accelerometer. Comparing with the single axis accelerometer in the earlier prototypes, MyotonPRO makes it more feasible for application.
Muscle metabolism (NIRS)
Time frame: At baseline and immediately after the completion of intervention
Muscle metabolic dysfunction will be measured by the near-infrared ray spectroscopy (NIRS). The NIRS will be applied to both the affected and the unaffected arms. The NIRS sensor will be fixed on the targeted muscle of one of the forearms and a cuff is placed on the upper arm of the same side. The artery occlusion will be applied by inflating the cuff to a pressure of at least 60 to 80 above systolic pressure to block both venous outflow and artery inflow. The artery occlusion will last approximate 30 seconds then the cuff pressure is released. The decrease rate of oxyhemoglobin and the increase rate of deoxyhemoglobin during artery occlusion can reflect muscle's anaerobic metabolism during vasoconstriction. The hyperaemic response of the muscle during recovery phase can be characterized by reoxygenation rate and recovery time.
Box and Block Test (BBT)
Time frame: At baseline and immediately after the completion of intervention
The BBT will be used as a test of manual dexterity. There are 150 blocks in a test box. When testing begins, the subject should grasp one block at a time with dominant hand, transport the block over the partition, and release it into the opposite compartment. Instruction of this test is "I want to see how quickly you can pick up one block at a time with your right (or left) hand [point to the hand]. Carry it to the other side of the box and drop it. Make sure your fingertips cross the partition." The testing time is one minute. Then, the procedure will be repeated with the nondominant hand. After testing, the examiner should count the blocks. The score is the number of blocks carried from one compartment to the other in one minute. Score for each hand will be separately calculated.
Revised Nottingham Sensory Assessment (RNSA)
Time frame: At baseline and immediately after the completion of intervention
The changes on somatosensory function will be determined by the RNSA. This is a standardized tool with good reliability to measure sensory function in the stroke population.The RNSA includes 3 major types of sensation: tactile sensation, proprioception, and stereognostic sense. For the purpose of this study, the regions of upper limb will be selected to be assessed.
Functional Independence Measure (FIM)
Time frame: At baseline and immediately after the completion of intervention
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 low score on any subscale indicates a more severe disability.
Motor Activity Log (MAL)
Time frame: At baseline, immediately after the completion of intervention, at a 6-month follow up
The MAL will be used to capture the level of use of affected upper limb in daily living. The MAL is a semi-structured interview assessing the amount of use (AOU) and quality of movement (QOM) of the affected arm in 30 main daily activities. It scores 0-5 for each activity. Higher score means better performance of the affected arm.
ABILHAND Questionnaire
Time frame: At baseline, immediately after the completion of intervention, at a 6-month follow up
The ABILHAND Questionnaire will be used to evaluate the ability of upper limb in bimanual activities. There are 23 bimanual activities to measure subjectively perceived difficulty of patients in performing some common activities in daily living, such as buttoning, cutting nails, and opening a bottle. It scores on a scale of 0-3 (0-cannot perform, 1-performs partially or with great difficulty, 2-performs with some difficulty, 3-performs fully). Its reliability and construct validity has been confirmed.
Adelaide Activities Profile (AAP)
Time frame: At baseline, immediately after the completion of intervention, at a 6-month follow up
The AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities. It scores on a scale of 0-3, with higher score indicating more frequent participation.
EQ-5D-5L
Time frame: At baseline and immediately after the completion of intervention
The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
Accelerometers
Time frame: At baseline, immediately after the completion of intervention, at a 6-month follow-up.
The activity monitors (i.e. accelerometers) will be used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. This measure, quantitatively recording the amount of activity in free-living conditions, will be used to reflect increase in the amount of affected arm use over time. The participants will be asked to wear an accelerometer on each arm for 3 consecutive days to measure what they actually do. The accelerometers to be used will be wireless plastic units about the size and weight of a large wristwatch that will be worn proximal to the wrist on terrycloth bands.
Functional magnetic resonance imaging (fMRI)
Time frame: At baseline and immediately after the completion of intervention
Participants will receive fMRI scanning before and after the intervention on a 3T clinical MRI scanner at Chang Gung Memorial Hospital in Linkou. During the scanning sessions, the head and the unaffected hand of the participants will be restrained and stabilized in a head coil and by a customized splint mask and a wooden apparatus with straps, respectively. Both of their upper limbs will be posited by their torsos. During the two sessions of examination, the relative activity time courses of the blood oxygenation level-dependent (BOLD) response will be collected for further analysis.
Kinematic analysis
Time frame: At baseline and immediately after the completion of intervention
The kinematic analysis will involve unilateral and bilateral tasks, in which the participants will be asked to perform by using the affected upper limb or both upper limb simultaneously. A motion analysis system with 7 cameras (VICON MX 30d, Oxford Metrics Inc., Oxford, UK) will be used to capture the motion of arm (s) in kinematic testing. The markers will be attached on the styloid processes of the ulna. Depending on the unilateral or bilateral tasks, the makers will be placed on the affected arm or the both arms, respectively.
Inflammatory markers
Time frame: At baseline and immediately after the completion of intervention
Proinflammatory markers and anti-inflammatory markers will be used to reflect the changes on inflammation. Proinflammatory markers include C-reactive protein, tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6, soluble intercellular adhesion molecule (sICAM), and matrix metalloproteinase 9 (MMP 9). Anti-inflammatory markers include IL-10 and IL-1 receptor antagonist.
Oxidative stress markers
Time frame: At baseline and immediately after the completion of intervention
Oxidative stress markers and antioxidative markers will be used to reflect the changes on oxidative stress. Oxidative stress makers include malondialdehyde (MDA), 8-Hydroxy-2-deoxyguanosine (8-OHdG), and immunoglobulin G (IgG), whereas antioxidants include superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase.
Erythrocyte deformability
Time frame: At baseline and immediately after the completion of intervention
The Elongation Index (EI) will be used to determine the red blood cell deformability, which is based on an isointensity curve in the diffraction pattern by using an ellipse-fitting program. EI is calculated by (L-W)/(L+W), where L and W are the major and minor axes of the ellipse, respectively. The deformability index (δ) is defined as the ratio of the major to the minor axis length (L/W).
Blood glucose indicators
Time frame: At baseline and immediately after the completion of intervention
To investigate the relationships between blood glucose levels and functional outcomes, we will also test the level of glucose and HbA1C for the participants before and after rehabilitation intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 34695300Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT and Conventional rehabilitation (CR) in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: At baseline and immediately after the completion of intervention). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.