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Intensive Bimanual Therapy for Cerebral Palsy

N/A
Recruiting
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having a diagnosis of cerebral palsy or spastic hemiparesis encephalopathy
Having sensorimotor deficits of one or both upper limb (spastic hemiparesis with a dominance on one side of the body; Manual Ability Classification System (MACS) level 1, 2 or 3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 6-month post-intervention.
Awards & highlights

Summary

This trial will help researchers understand if an intensive bimanual therapy can improve arm movement and usage in everyday life for people with cerebral palsy.

Who is the study for?
This trial is for children with cerebral palsy who can understand and perform study tasks, have sensorimotor deficits in one or both arms (with a preference on one side), and are classified as MACS level 1 to 3. It's not for those with uncorrected vision issues, other major health problems that could interfere, or recent Botox injections in the arms.Check my eligibility
What is being tested?
The trial studies intensive bimanual therapy's effect on arm movement and everyday use of the most affected arm in kids with cerebral palsy. It also looks at how brain imaging might predict outcomes from this therapy.See study design
What are the potential side effects?
Since this intervention involves physical therapy rather than medication, typical side effects may include muscle soreness or fatigue following sessions. The specific risks will depend on each child's condition.

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 cerebral palsy or spastic hemiparesis.
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I have movement difficulties in one or both of my arms.
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I can understand and follow the study's tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 6-month post-intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 6-month post-intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical evaluation - Assisting Hand Assessment (AHA)
Clinical evaluation - Box and Blocks Test (BBT)
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
+9 more
Secondary outcome measures
Self-assessments - Canadian Occupational Performance Measure (COPM)
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MANUSExperimental Treatment1 Intervention
Children and youth living with cerebral palsy will take part in a 60-hour intensive bimanual therapy at Peps at Université Laval, during which they will play games and exercise to promote spontaneous use of the most affected hand. Participants will take part to pre-evaluation and 1-week and 6-month post-intervention.

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Who is running the clinical trial?

Laval UniversityLead Sponsor
422 Previous Clinical Trials
172,816 Total Patients Enrolled
1 Trials studying Cerebral Palsy
16 Patients Enrolled for Cerebral Palsy

Media Library

Intensive bimanual therapy Clinical Trial Eligibility Overview. Trial Name: NCT05423171 — N/A
Cerebral Palsy Research Study Groups: MANUS
Cerebral Palsy Clinical Trial 2023: Intensive bimanual therapy Highlights & Side Effects. Trial Name: NCT05423171 — N/A
Intensive bimanual therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423171 — N/A
~13 spots leftby Jan 2027
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