FES in Young Children With Perinatal Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02975180|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: FES Behavioral: Conventional||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Functional Electrical Stimulation to Improve Upper Extremity Function in Young Children With Perinatal Stroke: A Proof of Concept Study|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||February 6, 2020|
|Estimated Study Completion Date :||August 2021|
Unilateral and bimanual activities are performed with FES applied to the hemiparetic arm.
The MyndMove FES System (MyndTec Inc., Mississauga, ON) is a fully programmable FES device with eight channels. This system allows motor practice of 17 different reaching and grasping protocols. The muscles stimulated may include the anterior, middle and posterior deltoid, biceps and triceps brachii, flexor digitorum superficialis and profundus, extensor digitorum, thenar eminence, lumbricals, and interossei. The sophistication of this system is unique. In contrast, many of the MyndMove stimulation protocols involve activation of small muscles that are used for fine motor control. The second FES device that will be used is the Odstock 2-channel Stimulator (FES Mobility Ltd., Vancouver, BC). While less sophisticated than the MyndMove system, it is smaller and more portable.
Unilateral and bimanual activities are performed with no FES applied to the hemiparetic arm.
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
- Change in Melbourne Assessment 2 score [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]The Melbourne Assessment 2 (MA2) evolved from the original Melbourne Assessment of Unilateral Upper Limb Function. It assesses the quality of arm movement in children as young as two years of age. It consists of four subscales (range of motion, dexterity, accuracy, and fluency) and involves performing 14 tasks, such as reaching, grasping and manipulating objects. It is scored from a video recording or live observation of a child playing with standardized objects. The MA2 is valid, and has high interrater reliability and good test-retest reliability in children with neurological conditions. Published standard error of measurement values for the raw Melbourne scores were used to calculate the minimally important difference for each subscale. Calculated MID values were as follows: range of motion = 4, accuracy = 4, dexterity = 2, and fluency = 4.
- Change in Assisting Hand Assessment score [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]The Assisting Hand Assessment (AHA) was designed for use in children with a hemiplegic arm aged 18 months - 5 years. It measures how well children use their affected arm in bimanual activities, such as spontaneous handling of toys during play. Like the MA2, the AHA is routinely scored from a video recording. The validity, reliability and responsiveness of the AHA has been demonstrated in children with hemiplegic cerebral palsy. Raw AHA scores will be converted to a logit-based 0-100 scale in AHA units. Five AHA units represent the smallest detectable change.
- Change in Modified Tardieu Scale score [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]The Modified Tardieu Scale is a measure of spasticity that considers resistance to passive stretch of a muscle at slow and fast speeds. This scale has been used in children with cerebral palsy as young as 3 years of age, and has adequate interrater reliability in this population. To perform this assessment, the child's affected elbow and wrist will be passively moved through the available range of motion at slow and fast speeds. The angle of the 'catch' in the passive joint movement (i.e., R1), and the full passive range of motion (i.e., R2) will be noted. For this measure, a researcher will secure electrogoniometers over the affected elbow and wrist, and place electromyography recording electrodes over the triceps, biceps, wrist extensors and wrist flexors on the affected side. We expect this to increase the robustness of this clinical measure in children, and have previously found this instrumented approach to be useful.
- Change in quantity of arm movement in daily life (accelerometry) [ Time Frame: 2 baseline assessments, after 18 treatment sessions, after 36 treatment sessions, 6 weeks post-treatment, 12 weeks post-treatment, 6 months post-treatment ]Accelerometry will be used to assess UE movement in daily life. Participants will be asked to wear a wGT3X-BT wireless activity monitor (Actigraph) on each wrist for seven consecutive days, with the aim of achieving a total of 24 hours of wear time (monitor removed during treatment sessions). Accelerometry is a valid method of assessing UE activity in adults with stroke and a MSc student in Dr. Musselman's lab is currently validating the tool in children with hemiparesis. Raw activity counts for the two arms will be collected, and the ratio of impaired to unimpaired UE activity will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975180
|Toronto Rehabilitation Institute-University Health Network|
|Toronto, Ontario, Canada, M4G 3V9|