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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
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Select...
I can understand and follow the study's tasks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured 6-month post-intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 6-month post-intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical evaluation - Assisting Hand Assessment (AHA)
Clinical evaluation - Box and Blocks Test (BBT)
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
+9 moreSecondary study objectives
Self-assessments - Canadian Occupational Performance Measure (COPM)
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
431 Previous Clinical Trials
178,407 Total Patients Enrolled
1 Trials studying Cerebral Palsy
16 Patients Enrolled for Cerebral Palsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that could affect my participation.I have been diagnosed with cerebral palsy or spastic hemiparesis.I have movement difficulties in one or both of my arms.I can understand and follow the study's tasks.My condition or situation matches one of three specific criteria.I have had a Botox injection in my arm(s) within the last 4 months.I can understand and follow the study's tasks.I have movement and feeling loss in one or both arms, more on one side.
Research Study Groups:
This trial has the following groups:- Group 1: MANUS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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