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Behavioural Intervention

Play-Based Training for Childhood Hemiplegia

N/A

Recruiting

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with hemiplegia by a medical doctor with clear asymmetry in upper extremity strength and control (i.e., one upper limb is clearly weaker than the other)

Can maintain a supported sitting position for at least 15 minutes

Must not have

Uncorrected blindness/profound visual impairment

Fixed deformities at wrist or hand

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test two different play-based training programs for children aged 3 to 8 with hemiplegia, a condition that affects one side of the body. The programs involve using either

Who is the study for?

This trial is for children aged 3 to 8 with hemiplegia, often due to cerebral palsy. It's designed to help improve arm function through play-based training programs at home or in community settings. The child and caregiver will work together with researchers.

What is being tested?

The study compares two types of training: SPEED Training uses joystick-operated powered ride-on toys, while CRAFT Training involves creative activities for upper extremity improvement. Researchers want to see which program better enhances arm motor skills and daily use of the affected arm.

What are the potential side effects?

Since this trial focuses on non-invasive play-based interventions, significant side effects are not anticipated. However, there may be general fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with hemiplegia, and one of my arms is clearly weaker than the other.

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I can sit up with support for at least 15 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am legally blind or have severe vision loss.

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I have permanent stiffness or bending in my wrist or hand.

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I cannot control my affected upper limb.

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I cannot follow 2-step directions.

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I weigh more than 150 lbs.

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My condition only affects my lower limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in hand grip strength

Changes in use of affected arm in functional activities

Treatment adherence

+2 more

Secondary study objectives

Change in affected arm movement control

Changes in child engagement during training sessions

Changes in habitual arm activity and arm asymmetry

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SPEED (Strength and Power in upper Extremities through Exploratory Driving)Experimental Treatment1 Intervention

Children will receive training focused on improving affected arm function using modified, joystick-operated ride-on toys. The commercial ride-on toys will be modified to allow operation in a single joystick control mode provided on the child's affected side. The manualized SPEED sessions will involve 2 components: (a) Multidirectional navigational games where children will use their affected UE to drive and maneuver the toy and (b) Object-based UE tasks completed at intermediate stops/stations during navigation. Navigational opportunities will encourage children to navigate through paths of different shapes, sizes, and complexity levels (e.g., straight, circle, diamond, slalom, obstacle courses etc.) Object-based tasks will encourage functional UE movement patterns during object interactions such as reaching, throwing, catching, pulling, pushing, lifting, knocking, holding, grasping, opening, closing, release, and manipulation.

Group II: CRAFT (Creative Rehabilitation for Arm Functional Training)Active Control1 Intervention

Children will engage in seated creative motor games focused on promoting gross and fine motor UE function. Training sessions will encourage use of the affected UE during unimanual and bimanual activities. Each training session will involve the following components: (a) Stretching exercises and (b) Task-oriented strengthening activities. Stretching exercises will involve range of motion exercises to encourage active warmup of proximal (shoulder, elbow) and distal (wrist, hand) UE muscles and movement dissociation. Task-oriented strengthening will involve use of the affected UE as a mobilizer and a stabilizer during building (e.g., Play-Doh, blocks, puzzles) and art-craft activities (e.g., folding, cutting, pasting, coloring). Task-oriented practice will emphasize skills such as reaching, grasping, release, and manipulation of training supplies.

0 / 8Eligibility criteria met