The CHAMP-T2 study is a pilot study of the efficacy of constraint induced movement
therapy (CIMT) when delivered by tele-video in the child's home or home-like environment.
This study will examine the pre-, post-intervention function of the paretic limb in
children who have hemiplegic cerebral palsy. The purpose is to develop an effect size
estimate that will inform the design of a future study that will compare tele-delivered
CIMT with usual and customary care.
Primary Aim: To determine the effect of tele-delivered CIMT (CHAMP-T protocol) upon upper
extremity (UE) motor function in school-aged children with post-stroke hemiparesis. The
hypothesis is that the motor function of the paretic UE will improve significantly
following tele-delivered CIMT.
The primary outcome will be the change in function of the impaired upper limb as measured
by the Melbourne Assessment of Unilateral Upper Limb Function (MAUULF) (16) The secondary
outcome will be the use of the affected limb in bilateral function as assessed with the
Assisting Hand Assessment (AHA),(17) a well-established measure of an impaired upper limb
in bilateral activities that is validated in children ages 18 months to 18 years. The
parents will report their observation of the function of the affected limb also at
baseline and at the end of the 4-week intervention. The reporting will use the Pediatric
Motor Activity Log (PMAL),(18) which is a published, validated measure that was included
in the study team's prior studies.(1) Fidelity to the treatment protocol will be assessed
by parents' logs of the number of hours of treatment intervention the child undergoes,
the recorded hours that the child wears the splint, and review of the recorded video
sessions. Parent-therapist communication will be assessed by the Parent-Therapist
information exchange tool. Factors affecting treatment delivery, including obstacles and
barriers to task performance as well as supports that might assist performance in a
larger clinical trial will be evaluated through semi-structured interviews and
observations of treatment sessions with the parent and the treating therapist.
There will be a pre- and post-intervention assessment of the effect of tele-delivered
CIMT delivered for 60 hrs over 4 weeks upon motor function of the paretic UE. After
informed consent is obtained families will be asked to provide details regarding the
child's medical history and diagnoses, previous treatments for cerebral palsy, and will
be assessed for cerebral palsy severity.
The study will treat 10 children with hemiplegic cerebral palsy with the CHAMP-T2
protocol. Five families will be trained in- person by the therapists regarding basic
principles of CIMT and how to use the televideo ensemble. Five families will receive the
same training virtually. The CHAMP-T2 version of CIMT will be delivered 3 hours per day,
5 days per week, for 4 weeks by tele-delivery in the subject's home. The therapist will
work with the parent by tele-video for 2 of the 3 hours to deliver the CIMT. The parent
will work directly with the child without the therapist for a 3rd hour of each session.
The children will wear the immobilization splint continuously each day up to 90% of the
waking hours during the CIMT intervention period of 4 weeks.
The children will have UE motor function assessment at baseline and immediately
post-treatment performed by blinded assessors. The parents, patients, and treating
therapists will not be blinded.
After enrollment, a baseline assessment of motor function will be performed at the study
center. For five children, the therapist then will travel to the child's home for 2 days
of in-person training of the parent in the principles of CIMT and in the use of the
iPad-Kubi Robot device. For the remaining five children the training will be performed by
video. In the treatment phase of the study, the therapist will lead each therapy session
by video for the first and third hours of the intervention. The second hour the parent
will deliver the CHAMP-T2 intervention without the therapist on-line. During the
therapist participation they will integrate parent coaching in the sessions to increase
parent engagement and confidence with their delivery of the intervention. Video will be
streamed live and recorded. Parent training and coaching will incorporate key elements
(observation, action, reflection, feedback, and joint planning) (19) along with
developing shared goal setting, problem solving and provision of feedback, education.
Fidelity to the treatment protocol will be assessed by parents' logs of the number of
hours of treatment intervention the child undergoes, the recorded hours that the child
wears the splint, and review of the recorded video sessions. Parent-therapist
communication will be assessed by the Parent-Therapist information exchange tool. Factors
affecting treatment delivery, including obstacles and barriers to task performance as
well as supports will be evaluated through semi-structured interviews and observations of
treatment sessions with the parent and the treating therapist. Parents will complete the
Accessibility Intervention, Feasibility Intervention, and Intervention Appropriateness
Measures (AIM, IAM, and FIM) to evaluate the treatment protocol and the Usefulness,
Usability, and Desirability (UUD) measures to assess the study technology.