NCT03807557

Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection

Effects of Robotic Modified Constraint -Induced Therapy on Behavioral Outcomes and Motor-learning Process in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin Type A Injection: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection. Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day). Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants. Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) \* 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.

Conditions

• Stroke
• Hemiplegia, Spastic

Interventions

Type	Name	Description
OTHER	Robotic Constraint-induced movement therapy	i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique. ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks. iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic.
OTHER	conventional UE rehabilitation training	focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.

Timeline

• Start date: 2019-01-30
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-01-17
• Last updated: 2021-07-29

Locations

1 site across 1 country: Taiwan