Robotic Rehabilitation and Brain Stimulation for Children With Hemiparetic Cerebral Palsy
RoboCP
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2019
CompletedFirst Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 18, 2020
January 1, 2020
1.8 years
January 15, 2020
January 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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)
Assisting Hand Assessment
change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Box and Block Assessment
change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Purdue Pegboard
change between pre-assessment (within 1 week of starting intervention) and post-assessment (within 1 week of completing intervention)
Study Arms (2)
Robot + tDCS
EXPERIMENTAL10 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.
Robot + sham tDCS
SHAM COMPARATOR10 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.
Interventions
Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.
Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Related Publications (1)
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.
PMID: 36188922DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean P Dukelow, MD, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
March 25, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
January 18, 2020
Record last verified: 2020-01