Overview

This trial is active, not recruiting.

Condition stroke
Treatments botulinum toxin type a, robot-assisted therapy, mirror therapy, control intervention
Phase phase 3
Sponsor Chang Gung Memorial Hospital
Start date February 2016
End date October 2016
Trial size 60 participants
Trial identifier NCT02749591, 104-9732A3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
botulinum toxin type a Botulinum Toxin
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
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)
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.
botulinum toxin type a Botulinum Toxin
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
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)
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.
botulinum toxin type a Botulinum Toxin
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
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 Outcomes

Measure
Motor function assessed on Fugl-Meyer Assessment (FMA)
time frame: Change from baseline at 5 months

Secondary Outcomes

Measure
Muscle power assessed on Medical Research Council Scale (MRC)
time frame: Change from baseline at 5 months
Muscle tone assessed on Modified Ashworth Scale (MAS)
time frame: Change from baseline at 5 months
The functional state assessed on Myometer Assessment
time frame: Change from baseline at 5 months
The amount of movement assessed on Actigraph Assessment
time frame: Change from baseline at 2 months
The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)
time frame: Change from baseline at 5 months
Walking speed assessed on Ten Meter Walk Test (10MWT)
time frame: Change from baseline at 2 months
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
time frame: Change from baseline at 5 months
The quality of movement and amount of use assessed on Motor Activity Log (MAL)
time frame: Change from baseline at 5 months
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 participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)
time frame: Change from baseline at 2 months
The participants' individual goals assessed on Goal attainment scale (GAS)
time frame: Change from baseline at 5 months
Revised Notttingham Sensory Assessment (RNSA)
time frame: Change from baseline at 2 months
Stroke Impact Scale (SIS)
time frame: Change from baseline at 5 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jen-Wen Hung
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.