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

NCT02749591 | Completed Phase 3

• 1 other identifier: 104-9732A3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke rehabilitation; spasticity; Botulinum toxin type A injection; robot-assisted therapy; mirror therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Motor function assessed on Fugl-Meyer Assessment (FMA)

  The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  Change from baseline at 5 months

Secondary Outcomes (13)

• Muscle power assessed on Medical Research Council Scale (MRC)

  Change from baseline at 5 months

• Muscle tone assessed on Modified Ashworth Scale (MAS)

  Change from baseline at 5 months

• The functional state assessed on Myometer Assessment

  Change from baseline at 5 months

• The amount of movement assessed on Actigraph Assessment

  Change from baseline at 2 months

• The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline at 5 months

Study Arms (3)

Robot-assisted therapy (RT)

EXPERIMENTAL

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; Other: Robot-assisted therapy

Mirror therapy (MT)

EXPERIMENTAL

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; Other: Mirror therapy

Control Intervention (CI)

ACTIVE COMPARATOR

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; Other: Control intervention

Interventions

Botulinum Toxin Type A 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

Also known as: Botulinum Toxin

Control Intervention (CI); Mirror therapy (MT); Robot-assisted therapy (RT)

Robot-assisted therapy 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.

Robot-assisted therapy (RT)

Mirror therapy 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.

Mirror therapy (MT)

Control intervention 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.

Control Intervention (CI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung City, 833, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 16777777 RESULT

• 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.

  PMID: 25592185 RESULT

• 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.

  PMID: 10896696 RESULT

• 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.

  PMID: 3809245 RESULT

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Jen-Wen Hung

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 25, 2016
• Study Start: May 2, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 18, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)