Clinical trial NCT02749591: Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke rehabilitation
spasticity
Botulinum toxin type A injection
robot-assisted therapy
mirror therapy
randomized controlled trial
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Motor function assessed on Fugl-Meyer Assessment (FMA)
timeFrame: Change from baseline at 5 months
Secondary outcomes:
measure: Muscle power assessed on Medical Research Council Scale (MRC)
timeFrame: Change from baseline at 5 months
measure: Muscle tone assessed on Modified Ashworth Scale (MAS)
timeFrame: Change from baseline at 5 months
measure: The functional state assessed on Myometer Assessment
timeFrame: Change from baseline at 5 months
measure: The amount of movement assessed on Actigraph Assessment
timeFrame: Change from baseline at 2 months
measure: The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline at 5 months
measure: Walking speed assessed on Ten Meter Walk Test (10MWT)
timeFrame: Change from baseline at 2 months
measure: The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
timeFrame: Change from baseline at 5 months
measure: The quality of movement and amount of use assessed on Motor Activity Log (MAL)
timeFrame: Change from baseline at 5 months
measure: The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Change from baseline at 5 months
measure: The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline at 2 months
measure: The participants' individual goals assessed on Goal attainment scale (GAS)
timeFrame: Change from baseline at 5 months
measure: Revised Notttingham Sensory Assessment (RNSA)
timeFrame: Change from baseline at 2 months
measure: Stroke Impact Scale (SIS)
timeFrame: Change from baseline at 5 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jen-Wen Hung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.
citation: Amano S, Takebayashi T, Hanada K, Umeji A, Marumoto K, Furukawa K, Domen K. Constraint-Induced Movement Therapy After Injection of Botulinum Toxin Type A for a Patient With Chronic Stroke: One-Year Follow-up Case Report. Phys Ther. 2015 Jul;95(7):1039-45. doi: 10.2522/ptj.20140329. Epub 2015 Jan 15.
citation: Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):217-21. doi: 10.1136/jnnp.69.2.217.
citation: Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.