Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

Phase 2

• Conditions: Hemiplegic Cerebral Palsy; Perinatal Stroke
• Interventions: Behavioral: Robotic Rehabilitation + sham tDCS; Combination Product: Robot Rehabilitation + tDCS

• Registration Number: NCT04233710
• Lead Sponsor: University of Calgary

Brief Summary

This study evaluates the use of robotic rehabilitation with and without transcranial direct current stimulation (tDCS) to improve motor performance in children with hemiparetic cerebral palsy. Half of the participants will receive robotic rehabilitation and half will receive robotic rehabilitation with tDCS. We hypothesize that tDCS may augment the robotic therapy and show greater improvements than robotic therapy alone.

Detailed Description

The defining feature of hemiparetic cerebral palsy is motor impairments primarily on one side of the body. Robotic rehabilitation and non-invasive brain stimulation are both emerging technologies that may be beneficial in improving motor performance in individuals with hemiparetic cerebral palsy. Robotic rehabilitation can allow for hundreds of arm movements in the span of an hour, a level of concentrated repetitions that is not possible in traditional rehabilitation. Additionally, robotics can target specific deficits, such as coordinating both arms together, improving accuracy of reaching movements, or improving proprioception, while simultaneously giving the therapist and patient quantitative feedback on performance. Non-invasive brain stimulation using transcranial direct current stimulation (tDCS) can safely modulate activity in regions of the brain and has emerged as a tool to enhance motor learning in typically developing children and augment therapy in children with hemiparetic cerebral palsy.

Children with hemiparetic cerebral palsy will be randomized to receive robotic rehabilitation with tDCS or robotic rehabilitation with sham-tDCS. Participants and the assessors will be blinded to the treatment. All children will complete 10 sessions within 3 weeks of 1.5 hours of robotic rehabilitation. The Kinarm Exoskeleton Robot will be used and children will play games with their affected arm or both arms to target different aspects of sensorimotor control. Children will simultaneously receive real or sham tDCS for the first 20 minutes of the session. tDCS will consist of 1 mA current with the cathode applied over the contralesional M1 area. All children will be assessed before and after the 10 session intervention period using robotic and clinical measures of motor and sensory performance, and at a 3 month follow up.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-25
• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• confirmed diagnosis of hemiparetic cerebral palsy due to unilateral perinatal stroke
• age 6-18 years
• Manual Ability Classification System (MACS) Level I-III
• Modified Ashworth Score in shoulder and elbow <=3;
• Visual acuity (corrected) better than 20/50 in both eyes
• able to follow instructions and comply with protocol;
• able to give consent/assent;
• able to commit to all assessment and intervention sessions.

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Exclusion Criteria

• significant contractures in the upper extremity;
• other neurological conditions or active medical disease;
• unstable epilepsy;
• contraindications to tDCS;
• botulinum toxin A injections in the upper extremity in the past 6 months;
• upper extremity surgical intervention in past 6 months;
• involvement in another interventional study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot + sham tDCS	Robotic Rehabilitation + sham tDCS	10 sessions of 1.5 hrs of robotic therapy within a 3 week period with 20 minutes of SHAM tDCS applied during the first 20 minutes of the robotic therapy. As with experimental arm, electrode will be placed on contralesional M1. Current will ramp up and then immediately ramp down to simulate the cutaneous sensations felt with actual tDCS. Robotic therapy will be delivered with Kinarm Exoskeleton robot and use games to target unilateral and bilateral motor and sensory impairments.
Robot + tDCS	Robot Rehabilitation + tDCS	10 sessions of 1.5 hrs of robotic therapy within a 3 week period, with 20 minutes of 1mA cathodal tDCS applied to the contralesional M1 area during first 20 minutes of robotic therapy. Robotic therapy will be conducted using the Kinarm Exoskeleton robot and use games to target unilateral and bilateral motor and sensory impairments.

Primary Outcome Measures

Name	Time	Method
Reaching Accuracy	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)	Change in reaching accuracy as measured by initial direction error on robotic visually guided reaching task.

Secondary Outcome Measures

Name	Time	Method
Box and Block Assessment	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)	Measure of ability to reach, grasp and release that measures how many 1" cubes a child can move from one side of a box to another in 1 minute.
Standardized robotic measures of motor and sensory performance	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)	Robotic measures of spatiotemporal reaching (path length ratio, reaction time, movement speed, number of speed maximums), proprioception (variability in position matching) and bilateral object hitting task (number of balls hit with each hand). Each measure will be assessed as change from pre-assessment to immediate post-assessment
Assisting Hand Assessment	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)	Performance on clinical assessment that determines how effectively the affected limb is used on tasks typically requiring both arms.
Purdue Pegboard	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)	Measure of manual dexterity measured by how many small pegs a child can place in a pegboard in 30 seconds.

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada