Feasibility of Pediatric CIMT by Televideo

NCT05303883 | Completed

• 1 other identifier: STUDY00001867
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Motor impairments; Gross motor delays; Manual impairment; Upper extremity impairment

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) will assess intervention feasibility with a four-item measure. The measure includes four statements about the plausibility of implementing the intervention (the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).

  Within 2 weeks of intervention completion

• Acceptability of Intervention Measure (AIM)

  Acceptability of Intervention will be assessed through a four-item measure (AIM). The measure includes four statements about the appeal of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).

  Within 2 weeks of intervention completion

• Intervention Appropriateness Measure (IAM)

  Intervention Appropriateness will be assessed through a four-item measure (IAM). The measure includes four statements about the relevance or pertinence of the intervention (e.g. the intervention seems suitable; the intervention seems applicable; the intervention seems fitting; the intervention seems like a good match). Individuals rate the extent to which the agree with each statement on a five-level scale (completely disagree, disagree, neither agree or disagree, agree, completely agree).

  Within 2 weeks of intervention completion

• Usefulness, Usability and Desirability Assessment (UUD)

  The Usability of the remote delivery system (use of the iPad, Kubi robot; video upload) will be assessed with the UUD assessment. Usability includes three major components: usefulness, desirability, and usability. The UUD gathers data on usability (ease of use of the telehealth technology) (9 items), usefulness (value, relevance, and applicability of the telehealth technology) (10 items), and desirability (overall appeal or interest of the telehealth technology) (4 items). Items are rated a five-point Likert-type scale.

  Within 2 weeks of intervention completion

• Fidelity of Intervention Assessment

  This instrument assesses the extent to which the therapist adhered to fifteen core constructs of the intervention protocol. Evidence of adherence to high quality pediatric rehabilitation elements includes 6 constructs that are scored as Present (present-some and present-strong) or Absent. Includes items such as "collaboration between parent and therapist" and "aligning therapy with child's goals". Evidence of core components of pediatric constraint induced movement therapy is scored as Present or Absent. Includes items such as "high intensity of intervention" and occurs in "natural environment". Total score is number of core components present.

  Once per week during 4-week intervention period

Secondary Outcomes (2)

• Fidelity of Remote Assessment

  Within one week following the assessment

• Perceptions of Remote Assessment and Intervention

  Within one week following the intervention.

Other Outcomes (4)

• Parent therapist information exchange

  Within 1 week following intervention

• Abilhand-kids

  Within 2 weeks prior to start of intervention and within 1 week following intervention

• Box and Block

  Within 2 weeks prior to start of intervention and within 1 week following intervention

Study Arms (1)

Pediatric constraint induced therapy

EXPERIMENTAL

Constrained induced therapy for children with hemiplegic cerebral palsy. Three hours of therapy per day, for five days a week, for four weeks.

Other: Pediatric Constrained Induced Movement Therapy

Interventions

Pediatric Constrained Induced Movement Therapy OTHER

Constraint of the child's less-impaired upper extremity for first 17 days of treatment. Children wear a removable, lightweight constraint for the first 17 of 20 therapy sessions.

Pediatric constraint induced therapy

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (3)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Virginia Polytechnic Institute and State University

Roanoke, Virginia, 24016, United States

Location

Study Officials

• Warren Lo

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Amy Darragh

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Occupational Therapy Division in the School of Health and Rehabilitation Sciences in the College of Medicine

Model Details: All enrolled children will receive the intervention.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 31, 2022
• Study Start: April 20, 2022
• Primary Completion: October 18, 2023
• Study Completion: October 31, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)