Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy (RoboCP)

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.

Study Overview

• Status: Unknown
• Conditions: Hemiplegic Cerebral Palsy; Perinatal Stroke
• Intervention / Treatment: Combination product: Robot Rehabilitation + tDCS; Behavioral: Robotic Rehabilitation + sham tDCS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Rachel L Hawe, DPT, PhD; Phone Number: 403-944-1094; Email: rachel.hawe@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot + 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.	Combination product: Robot Rehabilitation + tDCS; Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.
Sham Comparator: Robot + 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.	Behavioral: Robotic Rehabilitation + sham tDCS; Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized robotic measures of motor and sensory performance	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	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Assisting Hand Assessment	Performance on clinical assessment that determines how effectively the affected limb is used on tasks typically requiring both arms.	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Box and Block Assessment	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.	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Purdue Pegboard	Measure of manual dexterity measured by how many small pegs a child can place in a pegboard in 30 seconds.	change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Sean P Dukelow, MD, PhD, University of Calgary

Publications and helpful links

General Publications

• Raess L, Hawe RL, Metzler M, Zewdie E, Condliffe E, Dukelow SP, Kirton A. Robotic Rehabilitation and Transcranial Direct Current Stimulation in Children With Bilateral Cerebral Palsy. Front Rehabil Sci. 2022 Feb 25;3:843767. doi: 10.3389/fresc.2022.843767. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: tDCS; non-invasive brain stimulation; robotic rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: REB17-1008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No