Clinical trial NCT04233710: Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy
Official title: Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemiplegic Cerebral Palsy
Perinatal Stroke
Keywords: robotic rehabilitation
tDCS
non-invasive brain stimulation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reaching Accuracy
timeFrame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Secondary outcomes:
measure: Standardized robotic measures of motor and sensory performance
timeFrame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
measure: Assisting Hand Assessment
timeFrame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
measure: Box and Block Assessment
timeFrame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
measure: Purdue Pegboard
timeFrame: change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sean P Dukelow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.