FES in Young Children With Perinatal Stroke

NCT02975180 | Completed

• 1 other identifier: 16-5970
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Change in Melbourne Assessment 2 score

  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.

  From enrollment to 6 months post-treatment

• Change in Assisting Hand Assessment score

  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.

  From enrollment to 6 months post-treatment

Secondary Outcomes (3)

• Change in Modified Tardieu Scale score

  From enrollment to 6 months post-treatment

• Change in quantity of arm movement in daily life (accelerometry)

  From enrollment to 6 months post-treatment

• Adherence

  From the start to the end of the 12-week intervention

Study Arms (2)

FES

EXPERIMENTAL

Unilateral and bimanual activities are performed with FES applied to the hemiparetic arm.

Device: FES

Conventional

EXPERIMENTAL

Unilateral and bimanual activities are performed with no FES applied to the hemiparetic arm.

Behavioral: Conventional

Interventions

FES DEVICE

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.

FES

Conventional BEHAVIORAL

Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.

Conventional

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• be aged 3-6 years
• have experienced a unilateral perinatal stroke
• show focal brain injury on an MRI
• 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)
• be able to maintain an unsupported sitting position for \>5 minutes.

You may not qualify if:

• any other disease, injury or condition that affects their UE motor function
• contractures of the hand, wrist or elbow
• an implanted electronic device
• peripheral nerve damage in the affected UE
• surgical hardware in the UE
• a history of epilepsy
• a skin rash or wound at a potential electrode site
• 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.

Sponsors & Collaborators

• Heart and Stroke Foundation of Canada: collaborator
• University of Alberta: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

Toronto Rehabilitation Institute-University Health Network

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2018
• Primary Completion: December 10, 2020
• Study Completion: July 31, 2021
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)