Clinical trial NCT05303883: Feasibility of Pediatric CIMT by Televideo
Official title: Feasibility of Pediatric Constraint Induced Movement Therapy Delivered Remotely for Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Motor impairments
Gross motor delays
Manual impairment
Upper extremity impairment
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: Virginia Polytechnic Institute and State University
First posted: 2022-03-31
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled children will receive the intervention.
Primary purpose: TREATMENT

Brief summary: The study will test a remotely delivered, intensive, therapist-led, pediatric CIMT intervention, to improve the quality and frequency of upper limb movement during functional activity. We will evaluate: remote assessment of patient motor outcomes; computer-based video interaction for parent training in shaping therapeutic activities; child, parent, and therapist interactions; remote delivery of treatment; and the usability and usefulness of technology (e.g. reliability of internet connection; video streaming). As a final product, the study will yield a feasible and acceptable tele-rehabilitation protocol that meets our fidelity and reliability criteria and is ready for larger-scale efficacy testing in children with hemiplegic CP, ages 1-10 years.

Detailed description: Cerebral palsy (CP) is a public health problem that affects 2-3 per 1000 children. Up to 75 % of children with cerebral palsy will have motor impairments that can lead to lifelong disability, therefore there is a need for effective treatment of these motor impairments. A body of evidence shows that intensive motor therapies can improve arm and hand (upper limb) motor function in children with CP. Constraint induced movement therapy (CIMT) is one of the motor therapies with the strongest evidence base for its effectiveness. Our team has developed an innovative CIMT protocol to treat upper limb impairments due to CP. This protocol combines 1) high dosage of motor treatments, (up to 3-6 hours of therapy per day for 20 days); 2) constraint of the unaffected arm, 3) the incorporation of behavior motivation techniques to encourage the child to perform increasingly complex motor tasks; 4) treatment within the home to promote generalization of the motor behaviors; and 5) a post-therapy treatment plan for the parents to continue after the formal CIMT protocol is done. In a recent randomized controlled trial, we tested the effect of this CIMT protocol on upper limb function in children with hemiplegic CP. Children who received CIMT at the 30-hour and 60-hour doses had significantly better function immediately post-treatment than children who received usual and customary care. This difference persisted at 6 months after treatment for the children who received the 60-hour dose. These results provide clear evidence that the higher therapy dose resulted in greater sustained improvement of upper limb function.

Through our work in this and other clinical trials, we recognized that our treatment protocol delivered in the home cannot be delivered to children who live in rural areas beyond the reach of our therapists or in urban communities whose families are unable to have therapists work in their homes for 20 days. This limitation disproportionately affects families who live in medically resource poor areas. To address this barrier to access, we propose to modify our CIMT protocol so it can be used for telehealth delivery. Rehabilitation by telehealth has drawn considerable attention in the adult stroke world. A small number of trials in adult stroke patients and a small pilot trial in pediatric patients with upper limb weakness have shown that upper limb rehabilitation by telehealth is feasible and can be as effective as that delivered in the clinic.

Based on this emerging evidence, we will test the feasibility of our CIMT protocol adapted for telerehabilitation. In a related study, we will refine our CIMT by soliciting the input of families and children who have undergone CIMT treatment, and the input of expert treating therapists and assessors regarding our protocol. In the current study, we will test this refined protocol in a pilot sample of five to seven children ages 1-10 years who have hemiplegic CP. We will evaluate whether the remotely delivered treatment maintains fidelity to the original version delivered in person; whether the treatment is feasible to deliver, and whether it is acceptable to families, therapists, and assessors. In addition, we will evaluate whether the remote assessment of fine and gross motor skills is feasible, reliable, and acceptable. These measures will be assessed by questionnaires, observation of assessment recordings, scoring of the outcome measure, and interviews of parents of and participating children (the primary stakeholders), as well as feedback from study assessors.

Our long-term goal is to implement effective, accessible, intensive upper-limb interventions for children with hemiparesis, using delivery methods that are accessible, available, and feasible for families representing socioeconomic, geographic, and racial/ethnic diversity. This clinical research study is an important step toward clinical implementation through translation of an evidence-based intervention to a potentially more accessible, practical and equitable delivery method for families of children with CP.

Eligibility criteria: Inclusion Criteria:

1. ages 1 - 10 years old at enrollment;
2. diagnosis of hemiplegic CP per parent report;
3. ability to participate in therapy 3 hours/day x 5 days/week x 4 weeks (dose based on CHAMP RCT results).

Exclusion Criteria:

1. uncontrolled seizures;
2. medical or other complex conditions that preclude tolerance of 3 hours of intensive therapy per day

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Within 2 weeks of intervention completion
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Within 2 weeks of intervention completion
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Within 2 weeks of intervention completion
measure: Usefulness, Usability and Desirability Assessment (UUD)
timeFrame: Within 2 weeks of intervention completion
measure: Fidelity of Intervention Assessment
timeFrame: Once per week during 4-week intervention period
Secondary outcomes:
measure: Fidelity of Remote Assessment
timeFrame: Within one week following the assessment
measure: Perceptions of Remote Assessment and Intervention
timeFrame: Within one week following the intervention.
Other outcomes:
measure: Parent therapist information exchange
timeFrame: Within 1 week following intervention
measure: Abilhand-kids
timeFrame: Within 2 weeks prior to start of intervention and within 1 week following intervention
measure: Box and Block
timeFrame: Within 2 weeks prior to start of intervention and within 1 week following intervention
measure: Structured Activity Session
timeFrame: Within 2 weeks prior to start of intervention and within 1 week following intervention
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Roanoke
country: United States
facility: Virginia Polytechnic Institute and State University
state: Virginia
Study officials:
affiliation: Nationwide Children's Hospital
name: Warren Lo
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Amy Darragh
role: PRINCIPAL_INVESTIGATOR
References: