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FES in Young Children With Perinatal Stroke

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ClinicalTrials.gov Identifier: NCT02975180
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
University of Alberta
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Every year about 1 out of every 1,600-5,000 infants has a stroke around the time of birth. Many of these children will have lifelong physical problems. For example, the arm muscles are often paralyzed. This makes every day activities, like reaching and grasping objects, very difficult. To date there are few effective treatments for the paralyzed arm of young children with stroke. The main objective of this study is to test whether a new kind of treatment, known as functional electrical stimulation (FES), is able to improve arm function in children with stroke. FES involves applying electrical currents to weak or paralyzed muscles. This enables movements, such as reaching and grasping, which can then be practiced. The investigators will compare the effectiveness of FES treatment to standard arm rehabilitation in children aged 3-6 years who had a stroke early in life. They will measure the effectiveness using a number of clinical measures of arm function. Other objectives of this project are to test how well children adhere to the treatment schedule, and to evaluate parent and child satisfaction with FES treatment.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: FES Behavioral: Conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FES
Unilateral and bimanual activities are performed with FES applied to the hemiparetic arm.
Device: FES
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.

Experimental: Conventional
Unilateral and bimanual activities are performed with no FES applied to the hemiparetic arm.
Behavioral: Conventional
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be aged 3-6 years
  2. have experienced a unilateral perinatal stroke
  3. show focal brain injury on an MRI
  4. be rated a level II, III or IV on the Manual Ability Classification System by a physical or occupational therapist (this a 5-point ordinal scale with levels II, III and IV described as "Handles most objects but with somewhat reduced quality and/or speed of achievement", "Handles objects with difficulty; needs help to prepare and/or modify activities" and "Handles a limited selection of easily managed objects in adapted situations", respectively)
  5. be able to maintain an unsupported sitting position for >5 minutes.

Exclusion Criteria:

  1. any other disease, injury or condition that affects their UE motor function
  2. contractures of the hand, wrist or elbow
  3. an implanted electronic device
  4. peripheral nerve damage in the affected UE
  5. surgical hardware in the UE
  6. a history of epilepsy
  7. a skin rash or wound at a potential electrode site
  8. received an injection of botulinum toxin to the UE within the past 6 months. Children entered into the study may be withdrawn at some point during the study if their skin is irritated by the FES treatment

    • they begin a new physical or pharmacological intervention during the treatment period of the study, and it affects UE function.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Toronto Rehabilitation Institute-University Health Network
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
University Health Network, Toronto
Heart and Stroke Foundation of Canada
University of Alberta
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02975180    
Other Study ID Numbers: 16-5970
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases