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

Phase 3

Completed

• Conditions: Stroke
• Interventions: Drug: Botulinum Toxin Type A; Other: Robot-assisted therapy; Other: Mirror therapy; Other: Control intervention

• Registration Number: NCT02749591
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-05-02
• Status Verified: 2017-05
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted therapy (RT)	Robot-assisted therapy	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.
Mirror therapy (MT)	Mirror therapy	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.
Control Intervention (CI)	Control intervention	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.
Robot-assisted therapy (RT)	Botulinum Toxin Type A	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.
Mirror therapy (MT)	Botulinum Toxin Type A	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.
Control Intervention (CI)	Botulinum Toxin Type A	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.

Primary Outcome Measures

Name	Time	Method
Motor function assessed on Fugl-Meyer Assessment (FMA)	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

Name	Time	Method
Muscle power assessed on Medical Research Council Scale (MRC)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
Walking speed assessed on Ten Meter Walk Test (10MWT)	Change from baseline at 2 months	The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
The quality of movement and amount of use assessed on Motor Activity Log (MAL)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)	Change from baseline at 2 months	The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.
The participants' individual goals assessed on Goal attainment scale (GAS)	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.
Revised Notttingham Sensory Assessment (RNSA)	Change from baseline at 2 months	The outcome will be measured at 3 time points: 0 week, 1week, and 8 weeks after recruitment.
Muscle tone assessed on Modified Ashworth Scale (MAS)	Change from baseline at 5 months	The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
The functional state assessed on Myometer Assessment	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.
The amount of movement assessed on Actigraph Assessment	Change from baseline at 2 months	The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
Stroke Impact Scale (SIS)	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.

Trial Locations

Locations (1)

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