Stroke Clinical Trial
Official title:
A Randomized Controlled Trial of Distributed Schedule of Robot Assisted Training After Botulinum Toxin Injection in Patient With Spastic Hemiplegic Stroke: Motor Learning Process and Behavioral Outcomes
NCT number | NCT03321097 |
Other study ID # | NMRPG8G0211 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | May 7, 2019 |
Verified date | August 2018 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this project is to examine and compare the immediate and long-term effects of
combined Botulinum toxin type A (BoNT-A) injection between condensed and distributed
robot-assisted training (RT) programs in patients with spastic hemiplegic stroke. Spasticity,
a common impairment after stroke, has a profound impact on activity and participation for
patients. According to the result of the investigator's ongoing study, the investigators
found BoNT-A injection combined with robot-assisted training is recommended to enhance
functional recovery for patients with spastic hemiplegic stroke. However, the optimal program
as considering the RT frequency is unknown.
The aims of this study are to determine and compare the immediate and longer-term effects
between condensed and distributed programs of RT following BoNT-A injection in subjects with
spastic hemiplegic stroke .
Participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned
to either condensed or distributed RT groups post BoNT-A injection. Each training session
included 40 minutes RT, followed by 40-minute functional training. The condensed group will
receive 4 sessions per week, for 6 weeks, the distributed group 2 sessions per week, for 12
weeks. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified
Ashworth Scale. Activity and participation measures include Wolf Motor Function Test, Motor
Activity Log, and Canadian Occupational Performance Measure. In addition, to directly reflect
a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will
be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment,
and 6-week follow-up. The investigators will also use the movement time of robot without
powered assistance and surface EMG to determine the motor learning processes of patients
receiving the two practice frequencies of RT.
This comparative efficacy study will be the first to examine and compare the motor learning
processes and immediate and long-term effects between condensed and distributed RT post BoNT
injection. The results may provide clinicians with the appropriate methods to scheduling RT
following BoNT-A injection to improve upper limb functions for patients with hemiplegic
spasticity stroke.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 7, 2019 |
Est. primary completion date | May 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. clinical and imagine diagnosis of a first or recurrent unilateral stroke = 3 months 2. upper limb spasticity (modified Ashworth scale of = 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon & Smith, 1987) 3. initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, & Feussner, 1992; Fugl Meyer, Jaasko, & Leyman, 1975; Park, Wolf, Blanton, Winstein, & Nichols-Larsen, 2008) 4. no serious cognitive impairment (i.e., Mini Mental State Exam score > 20) (Teng & Chui, 1987) 5. age = 18 years 6. willing to provide written informed consent Exclusion Criteria: 1. pregnant 2. with bilateral hemispheric or cerebellar lesions 3. sever aphasia 4. significant visual field deficits or hemineglect 5. contraindication for BoNT-A injection 6. treatment with BoNT-A within 4 months before recruitment 7. any fixed joint contracture of the affected upper limb 8. a history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | Chang Gung University, Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment (FMA) | The upper-extremity (UE) subscale of the FMA will be used to assess neuromusculoskeletal and movement related functions. It consists of 33 upper extremity items for the reflexes and movement of 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)(Fugl Meyer et al., 1975). Higher score indicates better motor function of UE. The maximum score is 66, and the minimum score is 0. Satisfactory psychometric properties of the FMA have been demonstrated(Hsueh & Hsieh, 2002;Platz et al., 2005). The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention. |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported | |
Primary | Wolf Motor Function Test (WMFT)-Time | The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks. The WMFT includes 17 tasks (15 function-based and 2 strength-based). In this study only 15 function-based tasks were used. Performances were timed and rated by using a 6-point ordinal scale ranging from 0 to 5 ,There are 2 different scores: the WMFT -Time (time required to complete the tasks) and WMFT -FAS (functional Ability Scale, where a score of 6 points is used to assess the functional capacity of each task: 0 indicating that the patient cannot attempt the task, and 5 where the movement seems normal) The item ratings and time are summed respectively, and the average item rating and time are reported.The minimum value of mean FAS is 0, maximum 5, the higher the better. The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after in |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported | |
Primary | Modified Ashworth Scale (Masiero et al.) | Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon & Smith, 1987). It uses a 6-level scale to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity (Pandyan et al., 1999). The maximum of MAS scale is 4, and the minimum is 0. The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), post intervention, 6 weeks after intervention. |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported | |
Primary | Wolf Motor Function Test (WMFT)-Function | The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks. The WMFT includes 17 tasks (15 function-based and 2 strength-based). In this study only 15 function-based tasks were used. Performances were timed and rated by using a 6-point ordinal scale ranging from 0 to 5 ,There are 2 different scores: the WMFT -Time (time required to complete the tasks) and WMFT -FAS (functional Ability Scale, where a score of 6 points is used to assess the functional capacity of each task: 0 indicating that the patient cannot attempt the task, and 5 where the movement seems normal) The item ratings and time are summed respectively, and the average item rating and time are reported.The minimum value of mean FAS is 0, maximum 5, the higher the better. The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after in |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported | |
Secondary | Canadian Occupational Performance Measure (COPM) | The COPM, a semi-structured interview, will be used to assess a participant's perception of the performance in the areas of self-care, productivity and leisure (Dedding, Cardol, Eyssen, & Beelen, 2004). The COPM can capture information about activities that the participant wants, needs or is expected to perform. The participant will be asked to rate five most important activities on a 10-point scale for performance, ranging from 1 (not at all able) to 10 (able to perform extremely well), and for satisfaction, ranging from 1 (not at all satisfied) to 10 (extremely satisfied)(Dedding et al.,2004). The COPM is a reliable, valid, and responsive outcome measure for practitioners and researchers (Carswell et al., 2004). The outcome will be measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention. |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported | |
Secondary | Goal Attainment Scale (GAS) | The Goal Attainment Scale (GAS) is a measure of participants' individual goals that could be achieved in the course of intervention. Each goal will be rated on a 5-point scale ranging from -2 to +2 (maximum +2, minimum -2, the higher score indicates a better outcome. ) These attainment levels were combined in a single T-score by applying the formula recommended by Kiresuk & Sherman, which accounts for variable numbers of goals, inter-correlation of goal areas and variable weighting: Total score = 50 +{(10S(wi xi ))/(0.7Swi 2 + 0.3(Swi )2 )½} where wi =weight assigned to the ith goal and xi = the score of the ith goal. In the first session, the therapist will discuss with the participants and their families to define the goals. In the last session, the therapist use the GAS to qualify interpretation results. The outcome is measured at 4 time points: 1 week before intervention, 5 weeks after injection (in the middle of intervention), post-intervention, 6 weeks after intervention. |
assessed at 1 week before intervention, 5 weeks after injection (in the middle of intervention), 1 week after intervention (post-intervention), 6 weeks after intervention., change from baseline at 1.5 months reported |
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