Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

Hemiplegic Cerebral Palsy Clinical Trial

— RoboCP  

Official title:

Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233710
• Other study ID #: REB17-1008
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2020
• Source: University of Calgary
• Contact: Rachel L Hawe, DPT, PhD
• Phone: 403-944-1094
• Email: rachel.hawe[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Perinatal Stroke

Intervention

Combination Product:
• Robot Rehabilitation + tDCS
Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.

Behavioral:
• Robotic Rehabilitation + sham tDCS
Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)