FES in Young Children With Perinatal Stroke
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Detailed description: 
      Primary Aim: To compare, in young children with perinatal stroke, the change in UE function
      between two treatment approaches: 1) FES treatment, and 2) conventional UE training.

      Secondary Aim 1: To compare the intensity (i.e., number of repetitions performed per
      treatment session) between FES treatment and conventional UE training.

      Secondary Aim 2: To compare adherence to the two treatment methods (FES treatment and
      conventional training).

      Secondary Aim 3: To evaluate parent and child satisfaction with FES treatment.

      This is a proof-of-concept, mixed methods, pilot study that will use a single-blind,
      randomized clinical trial design. The study will involve two sites: the University of Alberta
      in Edmonton, and the Toronto Rehabilitation Institute - University Health Network. The total
      study duration is three years, while the time commitment of each child is about 9 months.
      Participants will complete two baseline assessments spaced 1-2 weeks apart, and will then be
      randomized into one of two groups (FES treatment or conventional UE training). The treatment
      period will last 12 weeks, and will be followed by a 6 month follow-up period.

      Participants Twenty-four children (12 per treatment group) will participate. To reach the
      target of 24 children, a total of 30 children with perinatal stroke will be recruited. This
      allows for 20% attrition. As this is a pilot study, the sample size is based on a
      conservative estimate of the number of children the investigators anticipate being able to
      recruit and enroll over a three year period in the two participating cities.

      Participants will be recruited through numerous means, including two main clinical sites: the
      Glenrose Rehabilitation Hospital (Edmonton) and the Holland Bloorview Kids Rehabilitation
      Hospital (Toronto). Following recruitment, potential participants will be screened through a
      telephone interview by the Research Coordinator.

      Assessments Assessments of UE function and spasticity will be completed seven times
      throughout the study: pre-treatment (2 assessments spaced 1-2 weeks apart), after 18
      treatment sessions, after 36 treatment sessions (i.e., the completion of treatment), 6 weeks
      post-training, 12 weeks post-training and 6 months post-training. The primary outcome measure
      will be the Melbourne Assessment 2 (MA2). Secondary measures will be the Assisting Hand
      Assessment (AHA), the Modified Tardieu Scale, and accelerometry to assess UE use in daily
      life. A single occupational or physical therapist at each site will complete the assessments.
      The assessing therapists will be blind to group allocation and the study objectives.

      The parents of children who received FES treatment will be asked to participate in a
      semi-structured interview within one week of their child completing FES treatment. The
      interview will be completed over the phone by one of the study investigators. The interview
      will last 45-60 minutes. The Researcher will ask a series of open-ended questions concerning
      the family's experience with, and impressions of, FES treatment. The data collected from the
      semi-structured interviews will allow us to gauge parent and child satisfaction with FES
      treatment. The interview will be digitally recorded and transcribed verbatim off-line. The
      transcribed dialogue will be shared with the parents, who will be asked to indicate whether
      it is an accurate reflection of the interview (i.e., member check).

      Treatment Methods Participants will be randomized into one of two treatment groups, FES
      treatment or conventional UE training, using a matched pairs design. The children will be
      matched in pairs based on their Manual Ability Classification System level. This
      randomization method, which has been used in other studies working with a similar population,
      will remove bias in the comparison of the two groups by ensuring that a potential confounding
      variable (i.e., UE impairment) is equally distributed across groups. A Research Assistant who
      is not involved in this study will randomize the participants by picking a label out of a
      box. Both treatment methods will be provided by a single physical or occupational therapist
      at each site.

      The dosage of treatment will be the same for the two treatment groups: 3 sessions/week with
      each session lasting 1 hour for a total of 36 sessions or hours of training. Participants
      will be asked to repeat the same task >10 times during a single treatment session. Treatment
      sessions will be video recorded at regular intervals (i.e., at the first session, and every 9
      sessions thereafter) for two reasons. First the video data will allow the investigators to
      accurately quantify the intensity of each treatment method over time. The video will be
      viewed offline to document the number of repetitions performed of each type of grasp,
      direction of reach (forwards, lateral, across midline), etc. Second, the video data will be
      reviewed to ensure that the treatment being delivered adheres to the study protocol.

      FES treatment and conventional UE training will follow principles of motor learning and
      neuroplasticity, such as practicing many repetitions of salient tasks. The only difference
      between the two approaches will be that for the FES group, electrical stimulation will assist
      the children's movements. During a one hour training session, roughly half of the time will
      be spent focusing on unilateral activities with the affected UE (similar to CIMT), while the
      remaining time will be spent engaged in bimanual activities (similar to intensive bimanual
      training). The tasks practiced will be customized to the child's ability and goals, and will
      be embedded in play. Both proximal and distal muscles will be targeted, with no requirement
      of achieving proximal control prior to training distal movements. Previous work suggests that
      targeting impairments in the forearm, wrist and thumb with therapy also leads to improvements
      in proximal arm muscles. The treating therapist may provide manual assistance as needed to
      the child as he/she attempts a task. As motor control returns, the difficulty level of the
      tasks will be progressed by withdrawing assistance (manual or FES), and increasing the
      complexity of the tasks. If a child is able to complete a task 5-7 times without assistance
      and a near-normal movement pattern, the treating therapists will progress the task.

      The FES treatment group will receive electrical stimulation while participating in the
      functional training described above. At each session up to eight pairs of self-adhesive
      surface electrodes will be attached to the child's skin. A variety of toys will be used to
      keep children occupied during donning and doffing, which takes 5-10 minutes. If a child finds
      removing the electrodes uncomfortable, the electrodes can be dampened for easier removal. In
      adults, stimulation is more effective if it is combined with active movement. Thus, prior to
      facilitating a movement with FES, the children will be asked to attempt the movement
      themselves for about 10 seconds. After this time, FES will be triggered through a button
      pushed by the therapist to help execute the movement. Two commercially available FES devices
      will be used. One is the MyndMove FES System (MyndTec Inc., Mississauga, ON), which is a
      fully programmable FES device with eight channels. This system allows motor practice of 17
      different reaching and grasping protocols. For example, children can practice pinch grip,
      lumbrical grasp, palmar grasp, lumbrical hand opening, tripod grasp, etc., with and without
      reaching. The second FES device that will be used is the Odstock 2-channel Stimulator (FES
      Mobility Ltd., Vancouver, BC). The Odstock device may be used if the child is practicing
      reaching movements while walking outdoors or over longer distances indoors. Throughout the
      training period and at the completion of training, the treating therapist will provide
      parents and children in both treatment groups with education on how to promote use of the
      affected arm in daily activities at home. Integrating improved UE function into family
      routines is believed to be important for the retention of motor skill and transfer to
      everyday environments. Parents/guardians will be given a diary, in which they can record 1)
      activities involving the weak arm that their child practices at home, including the
      approximate length of time in minutes, and 2) new activities involving the weak arm that they
      observe their child doing.

      Participants will wear two accelerometers (wGT3X-BT wireless activity monitor, Actigraph),
      one on each wrist, for the duration of every treatment session. This will enable us to record
      the amount or frequency of arm movements elicited with each type of treatment.

      Data Analysis Data from the accelerometers will be uploaded and analyzed using ActiLife 6
      software (Actigraph). For each child, change scores on the clinical measures will be
      calculated as follows: score after 18 or 36 training sessions subtract the mean of the two
      baseline scores. A retention index will also be calculated for each child's performance on
      the measures as follows: the score at the 6-week or 12-week or 6-month follow-up divided by
      the score at the end of training (i.e., retention index of 1 = perfect retention). Group raw
      scores, change scores and retention indices on the outcome measures will be reported as mean
      + 1 standard deviation.

      For statistical tests, the alpha level will be set at 0.05. To test the assumption of
      normality, the Shapiro-Wilk test will be used. Non-parametric tests will be used when this
      assumption is not met. To address our primary aim, within-group and between-group changes on
      the primary and secondary outcome measures will be evaluated using a two-way repeated
      measures ANOVA, with the Bonferroni correction for post-hoc comparisons. The non-parametric
      Scheirer-Ray-Hare test will be used if appropriate. An intention-to-treat analysis will be
      used.

      Video footage of the treatment sessions will be reviewed to extract the total number of
      movement repetitions/session (intensity) for each child. Five sessions will be recorded/child
      (at the start of treatment and every 9 sessions thereafter). To compare the intensity of
      training between groups (Secondary aim 1), a two-way repeated measures ANOVA, or
      Scheirer-Ray-Hare test, will be used to compare the mean number of repetitions completed over
      the course of training between groups. The total number of hours trained (i.e., dosage) will
      be calculated for each child from the treating therapists' records. The percentage of
      children in each treatment group who complete >35 hours of training in 12 weeks will be
      reported. To compare the adherence to the two treatment methods (Secondary Aim 2), the total
      number of hours trained will be compared between groups using independent t-tests, or
      Mann-Whitney U tests.

      Following the member check (described above), the transcribed dialogue from the
      semi-structured interviews will be imported into NVivo 11 (QSR International) for data
      management, coding and analysis. An inductive, grounded approach will be taken for coding the
      interviews. The coding process will involve two researchers and one graduate student. First,
      the three researchers will independently review 3-4 interviews and take note of ideas and
      terms that reflect the content of the text. Next, the researchers will discuss the content
      and jointly develop a coding scheme (i.e., codes with definitions). This coding scheme will
      then be applied to the interviews by each of the researchers, with discrepancies being
      reconciled along the way. Lastly, together the researchers will group the identified codes
      into larger categories, and the relationships between these categories will be considered.
    

Intervention name(s): FES; Conventional
Intervention type(s): Device; Behavioral
Intervention description(s): 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.; Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment