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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04233710
Other study ID # REB17-1008
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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)
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