Health Trialsby

Implementation of Therapy Together

ConditionsCerebral Palsy Hemiplegic Cerebral Palsy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-71

SponsorTexas Scottish Rite Hospital for Children

About this trial

The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question\[s\] it aims to answer are:

* Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care? * Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?

Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at risk for developing cerebral palsy or have been diagnosed with cerebral palsy

children ages 3 months to 5 years 11 months

present with asymmetric hand use

present with a unilateral upper limb impairment

Disqualifiers

uncontrolled epilepsy

significant visual impairment

severe behavioral problems

inability to complete the assessment protocol.

Trial design

Design model

Crossover

Treatments tested in this trial

Therapy Together
Behavioral
8-week caregiver-led pediatric constraint-induced movement therapy program
Usual Care
Behavioral
8 weeks of usual care received in an early intervention therapy program

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Therapy TogetherExperimental treatment 1 intervention

Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mini-Assisting Hand Assessment

The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

2

Assisting Hand Assessment

The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

3

Hand Assessment for Infants

The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Secondary outcomes

1

Canadian Occupational Performance Measure

The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

2

Developmental Assessment for Young Children, Second Edition (DAYC-2)

The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

3

Measure of Hand and Arm Performance

The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10

Time frame

baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Other outcomes

1

Pre-training and Post-training Therapist Survey

The pre-training and post-training survey includes questions on knowledge, appropriateness, and acceptability of pediatric constraint-induced movement therapy (includes likert scale questions, demographic questions, and open ended qualitative responses)

Time frame

Baseline, pre-intervention and within 1 month of post-intervention

2

Interviews with therapists and caregivers

Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data

Time frame

Within 1 month of post intervention

3

Weekly Caregiver Log

The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4

Time frame

weekly for 8 weeks

4

Weekly Therapist Log

Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses

Time frame

weekly for 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Scottish Rite Hospital for Children

Lead sponsor

American Occupational Therapy Foundation

Collaborator

Source ClinicalTrials.gov