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Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients

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ClinicalTrials.gov Identifier: NCT02749591
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy.

Condition or disease Intervention/treatment Phase
Stroke Drug: Botulinum Toxin Type A Other: Robot-assisted therapy Other: Mirror therapy Other: Control intervention Phase 3

Detailed Description:

The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A injection with mirror therapy (MT) and with bilateral robot-assisted (RT) in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. BoNT-A injection combined with rehabilitation training is recommended to enhance functional recovery for stroke patients with spasticity. Although the positive combination effects of BoNT-A with stretch, RT, and constraint-induced movement therapy were reported, the quality of the evidence was weak due to methodology limitations. In addition, patients with spasticity usually have lower motor function and worse sensory deficits than patients without spasticity. Designing the post BoNT-A injection rehabilitation program should consider the above issues. RT and MT are two interventions providing sensorimotor input for patient with low level of motor function. It is unknown whether combining BoNT-A injection with RT or with MT have positive effects and engenders differential effects on motor and related functional performance.

At least 60 participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to one of 3 groups: BoNT-A injection with RT, BoNT-A injection with MT, and BoNT-A injection with control intervention (CI). All the post-injection interventions will be implemented 60 minutes/day, 3 days/week, for 8 weeks. The RT group will receive 30-minute RT, followed by 30-minute functional training. The MT group will receive 30-minute MT, followed by 30-minute functional training. The CI group will receive 60-minute rehabilitation program, such as bilateral arm training and functional task practice. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale, Medical Research Council scale, myometer (Myoton-3), actigraph, and Pittsburgh Sleep Quality Index. Activity and participation measures include Wolf Motor Function Test, Ten meter walk test, Motor Activity Log, Nottingham Extended Activities of Daily Living Scale, 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 3-month follow-up.

This comparative efficacy study will be the first to examine and compare the immediate and long-term combination effects of BoNT injection with RT, MT, or CI. The follow-up assessments will provide the long-term effects of different treatments on health-related outcomes, which are crucial for community reentry. In addition, the results of objective assessments and patient-reported outcomes may lead to individualized upper limb training following BoNT-A injection for patients with spastic hemiplegic stroke.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Hybrid Effects of Combining Botulinum Toxin Type A With Robot-assisted Training v.s. With Mirror Therapy for Stroke Patients With Upper Extremity Spasticity: A Randomized Controlled Study
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Robot-assisted therapy (RT)
After injection with Botulinum Toxin Type A, a schedule of robot-assisted therapy appointments will be established. Each intervention includes 45 minutes of robotic training and 30 minutes of training in functional activities.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals
Other Name: Botulinum Toxin

Other: Robot-assisted therapy
After injecting Botulinum toxin type A on the spasticity upper extremity, the RT group will receive a 45 minutes of robotic training and 30 minutes of training in functional training.

Experimental: Mirror therapy (MT)
After injection with Botulinum Toxin Type A, a schedule of mirror therapy appointments will be established.The MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals
Other Name: Botulinum Toxin

Other: Mirror therapy
After injecting Botulinum toxin type A on the spasticity upper extremity, the MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.

Active Comparator: Control Intervention (CI)
After injection with Botulinum Toxin Type A, a schedule of control intervention appointments will be established.The CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
Drug: Botulinum Toxin Type A
To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals
Other Name: Botulinum Toxin

Other: Control intervention
After injecting Botulinum toxin type A on the spasticity upper extremity, the CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.




Primary Outcome Measures :
  1. Motor function assessed on Fugl-Meyer Assessment (FMA) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.


Secondary Outcome Measures :
  1. Muscle power assessed on Medical Research Council Scale (MRC) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  2. Muscle tone assessed on Modified Ashworth Scale (MAS) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  3. The functional state assessed on Myometer Assessment [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.

  4. The amount of movement assessed on Actigraph Assessment [ Time Frame: Change from baseline at 2 months ]
    The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.

  5. The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  6. Walking speed assessed on Ten Meter Walk Test (10MWT) [ Time Frame: Change from baseline at 2 months ]
    The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.

  7. The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  8. The quality of movement and amount of use assessed on Motor Activity Log (MAL) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  9. The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  10. The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from baseline at 2 months ]
    The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.

  11. The participants' individual goals assessed on Goal attainment scale (GAS) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.

  12. Revised Notttingham Sensory Assessment (RNSA) [ Time Frame: Change from baseline at 2 months ]
    The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.

  13. Stroke Impact Scale (SIS) [ Time Frame: Change from baseline at 5 months ]
    The outcome will be measured at 4 time points: 0 week, 1 week, 8 weeks, and 5 months after recruitment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to provide written informed consent
  • Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
  • Upper limb spasticity (Modified Ashworth scale of ≥ 2)
  • Moderate to severe movement impairment of U/E (FMA score ranging from 18 to 56)
  • No serious cognitive impairment (i.e., Mini Mental State Exam score > 18)
  • Age ≥ 18 years

Exclusion Criteria:

  • Pregnant
  • Bilateral hemispheric or cerebellar lesions
  • Significant visual field deficits or hemineglect
  • Contraindication for BoNT-A injection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749591


Locations
Taiwan
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Jen-Wen Hung Chang Gung Memorial Hospital

Publications of Results:
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02749591     History of Changes
Other Study ID Numbers: 104-9732A3
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
stroke rehabilitation
spasticity
Botulinum toxin type A injection
robot-assisted therapy
mirror therapy
randomized controlled trial

Additional relevant MeSH terms:
Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents