StrokeNCT03807557
Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection
A study testing Robotic Constraint-induced movement therapy and conventional UE rehabilitation training in people with Stroke and Hemiplegia, Spastic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Hemiplegia, Spastic
- What is being tested?
- Robotic Constraint-induced movement therapy and conventional UE rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2019to 30 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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 ≥ 20 years ; and (6) willing to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center
Kaohsiung City
About this study
Official title: Effects of Robotic Modified Constraint -Induced Therapy on Behavioral Outcomes and Motor-learning Process in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin Type A Injection: A Randomized Controlled Trial
Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection.
Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day).
Read more
Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants.
Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) * 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.
- Conditions
- Stroke, Hemiplegia, Spastic
- Being tested
- Robotic Constraint-induced movement therapy, conventional UE rehabilitation training
- Keywords
- Stroke rehabilitation, Botulinum toxin type A injection, robot-assisted therapy, Constraint-induced movement therapy, spasticity
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Constraint-induced movement therapyOther
i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique.
ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks.
iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic.
conventional UE rehabilitation trainingOther
focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Robotic mCIMT group | Experimental | 1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day Receives: Other: Robotic Constraint-induced movement therapy |
| Control group | Active comparator | conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day Receives: Other: conventional UE rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, and the maximum score is 66. Satisfactory psychometric properties of the FMA have been demonstrated(Platz et al., 2005)
Measured: Change from baseline at 1.5 months
Modified Ashworth Scale
Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon \& Smith, 1987).It uses a 6-point 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).
Measured: Change from baseline at 1.5 months
Actigraph
The amount of the impaired arm movement will be assessed by the activity monitors (i.e. accelerometers)(Schasfort, Busmann, Martens, \& Stam, 2006; Uswatte, Giuliani, et al., 2006; Uswatte et al., 2000). Accelerometers, objectively recording the amount of activity in free-living conditions and estimating energy expenditure, have been applied to measure the amount of affected arm use over time. In addition, accelerometers were also used to provide a measure of sleep latency and efficiency in this project. The participants were required to comply with wearing the accelerometer on each arm for 3 consecutive days. The accelerometers used in this project will be wireless plastic units about the size and weight of a large wrist watch. The participants will wear them proximal to the wrist on terrycloth bands. The compliance of wearing accelerometers was approximately 76% of waking time (Schasfort et al., 2006).
Measured: Change from baseline at 1.5 months
Wolf Motor Function Test (WMFT)
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Uswatte, Taub, Stuss, Winocur, \& Robertson, 1999). The WMFT includes 17 tasks (15 function-based and 2 strength-based). Performances were timed and rated by using a 6-point ordinal scale. The WMFT has good interrater reliability and criterion validity in patients with UE hemiparesis (D. M. Morris, Uswatte, Crago, Cook, \& Taub, 2001) .
Measured: Change from baseline at 1.5 months
Secondary outcomes (3)
Motor Activity Log (MAL)
The MAL is a semi-structured interview to rate how well [quality of movement scale (QOM)] and how much [amount of use scale (AOU)] they use their affected upper extremity in 30 daily activities using a 6-point scale (Uswatte, Taub, Morris, Light, \& Thompson, 2006). Higher scores represent better performance. The MAL has established reliability, validity, and responsiveness in patients with stroke (Uswatte, Taub, et al., 2006; Uswatte et al., 2005; Van der Lee, Beckerman, Knol, De Vet, \& Bouter, 2004) . The MAL will be used to measure daily use of the affected upper limb in daily life in this project.
Measured: Change from baseline at 1.5 months
Nottingham Extended Activities of Daily Living Scale (NEADL)
The NEADL is a measure of the requirement for help in performing instrumental activities of daily living (IADL) for patients with stroke(Nouri \& Lincoln, 1987). The NEADL has 22 items divided into 4 areas of daily life: mobility, kitchen, domestic, and leisure activities. Participants need to choose the level of the independence (not at all, with help, on your own with difficulty, on your own). The reliability, validity, and responsiveness of the NEADL have well-established in patients with stroke.(Gladman, Lincoln, \& Adams, 1993; Gompertz, Pound, \& Ebrahim, 1994; Nouri \& Lincoln, 1987).
Measured: Change from baseline at 1.5 months
Goal attainment scale (GAS)
The GAS is a useful measure of participants' individual goals that could be achieved in the course of intervention(Turner-Stokes, 2009). In the first session, the therapist will discuss with the participants and their families to define the goals. Each goal will be rated on a 5-point scale ranging from -2 to +2 in the last session. The higher score represents better performance. The GAS enables the data to be placed on a quantitative measurement scale and can be helpful for qualitative interpretation (Turner-Stokes, 2009). Evidence of validity and responsiveness for the GAS was reported in previous studies(Rockwood, Stolee, \& FoxP, 1993).
Measured: Change from baseline at 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start30 Jan 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University
- Responsible party
- Sponsor
- Investigators
- Jen-Wen Hung, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807557
- Sponsor's protocol ID
- CMRPG8H1261
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Robotic Modified Constraint -Induced Therapy on Behavioral Outcomes and Motor-learning Process in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin Type A Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03807557
- Acronym / sponsor ID
- CMRPG8H1261
- Conditions
- Stroke, Hemiplegia, Spastic
- Keywords
- Stroke rehabilitation, Botulinum toxin type A injection, robot-assisted therapy, Constraint-induced movement therapy, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- 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.
Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection.
Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day).
Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants.
Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) * 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic mCIMT group | Experimental | Other: Robotic Constraint-induced movement therapy1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day |
| Control group | Active comparator | Other: conventional UE rehabilitation trainingconventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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 ≥ 20 years ; and (6) willing to provide written informed consent.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Robotic Constraint-induced movement therapyi.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique. ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks. iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic. | Other | Robotic mCIMT group |
| conventional UE rehabilitation trainingfocusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities. | Other | Control group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Change from baseline at 1.5 months
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, and the maximum score is 66. Satisfactory psychometric properties of the FMA have been demonstrated(Platz et al., 2005)
Modified Ashworth Scale
Time frame: Change from baseline at 1.5 months
Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon \& Smith, 1987).It uses a 6-point 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).
Actigraph
Time frame: Change from baseline at 1.5 months
The amount of the impaired arm movement will be assessed by the activity monitors (i.e. accelerometers)(Schasfort, Busmann, Martens, \& Stam, 2006; Uswatte, Giuliani, et al., 2006; Uswatte et al., 2000). Accelerometers, objectively recording the amount of activity in free-living conditions and estimating energy expenditure, have been applied to measure the amount of affected arm use over time. In addition, accelerometers were also used to provide a measure of sleep latency and efficiency in this project. The participants were required to comply with wearing the accelerometer on each arm for 3 consecutive days. The accelerometers used in this project will be wireless plastic units about the size and weight of a large wrist watch. The participants will wear them proximal to the wrist on terrycloth bands. The compliance of wearing accelerometers was approximately 76% of waking time (Schasfort et al., 2006).
Wolf Motor Function Test (WMFT)
Time frame: Change from baseline at 1.5 months
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Uswatte, Taub, Stuss, Winocur, \& Robertson, 1999). The WMFT includes 17 tasks (15 function-based and 2 strength-based). Performances were timed and rated by using a 6-point ordinal scale. The WMFT has good interrater reliability and criterion validity in patients with UE hemiparesis (D. M. Morris, Uswatte, Crago, Cook, \& Taub, 2001) .
3 secondary outcomes
Motor Activity Log (MAL)
Time frame: Change from baseline at 1.5 months
Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Change from baseline at 1.5 months
Goal attainment scale (GAS)
Time frame: Change from baseline at 1.5 months
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 29 Jul 2021.
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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.
Jen-Wen Hung 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 Robotic Constraint-induced movement therapy and conventional UE rehabilitation training in people with Stroke and Hemiplegia, Spastic, 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 1 inclusion and 1 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 29 Jul 2021. 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: Change from baseline at 1.5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.