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

NCT ID: NCT02749591

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2017-11-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

Robot-assisted therapy

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

Mirror therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

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

Control intervention

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Botulinum Toxin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen-Wen Hung

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Kaohsiung City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 16777777 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25592185 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10896696 (View on PubMed)

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.

Reference Type: RESULT

PMID: 3809245 (View on PubMed)

Other Identifiers

104-9732A3

Identifier Type: -

Identifier Source: org_study_id