- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02840643
Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children with hemiplegia will be given an intensive hand therapy protocol for six weeks (6 hrs/day, 5 days/week - total of 180 hours. Therapy will be given in two blocks.
In one block (3 weeks, 90 hours of therapy), children will receive constraint-induced movement therapy (CIMT), also known as constraint therapy. During CIMT, children wear a mitt over their less-affected hand, which restricts use of that hand. Children engage in intensive therapy to improve active range of motion, strength, motor control and sensory awareness of the affected hand. Activities are functional and play based. Daily structure of therapy includes: morning gym, fine motor, gross motor, sensory motor, therapeutic feeding, sports and self care activities. During training, children perform play-based and functional activities with the affected hand. Example activities include playing card and board games, arts and crafts, and activities that provide sensory stimulation to the affected hand, such as finger painting. Activities also include stretching and strengthening exercises.
In one block (3 weeks, 90 hours of therapy), children will receive bimanual therapy. During bimanual therapy, children do not wear a mitt over the less-affected hand. Children will be provided individualized activities that facilitated active use of both hands. Therapists will adapt and grade activities and guided children to problem solve for success. Bimanual activities include self-care (tying shoes, zippering, cutting food), sports activities, and manipulation of classroom tools (cutting with scissors).
Before the intervention begins, children will be randomized to one of two arms. In Arm 1, children will receive 3 weeks of CIMT followed by 3 weeks of bimanual therapy. In Arm 2, children will receive 3 weeks of bimanual therapy followed by 3 weeks of CIMT.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kelly Au, OTR/L
- Phone Number: 914-831-2459
- Email: kellya@blythedale.org
Study Locations
-
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New York
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Valhalla, New York, United States, 10595
- Recruiting
- Blythedale Children's Hospital
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Contact:
- Kelly Au, OTR/L
- Phone Number: 914-831-2459
- Email: kellya@blythedale.org
-
Sub-Investigator:
- Sue McGinty, OTR/L
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Sub-Investigator:
- Julie Knitter, OTR/L
-
Sub-Investigator:
- Kathleen M Friel, PhD
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Principal Investigator:
- Kelly Au, OTR/L
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of hemiplegia.
- Wrist range of motion of at least 10 degrees.
- Able to follow directions.
- Experience attending day programs without the child's home caregiver present (i.e. school, daycare).
Exclusion Criteria:
- Uncorrected vision problems.
- Inability to communicate or follow directions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Constraint Therapy and Bimanual Therapy
Children in this arm will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of Intensive Hand Therapy (constraint therapy), followed by 90 hours (6 hrs/day, 5 days/week, 3 weeks) of Intensive Bimanual Hand Therapy (bimanual therapy).
During constraint therapy, children will wear a mitt over their less-impaired hand and actively use their more-impaired hand in therapy.
Therapy will involve playing games, practicing activities of daily living, doing arts and crafts, and practicing repetitive hand movements.
During bimanual therapy, children will actively use both hand in therapy.
Therapy will involve playing games, practicing activities of daily living, doing arts and crafts, and practicing repetitive hand movements.
|
Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive bimanual hand therapy, which involves actively using both hands in play-based activities, games, arts and crafts, and activities of daily living.
The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive constraint therapy, which involves actively using the impaired hand in play-based activities, games, arts and crafts, and activities of daily living.
The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
|
Experimental: Bimanual Therapy and Constraint Therapy
Children in this arm will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of Intensive Bimanual Hand Therapy (bimanual therapy), followed by 90 hours (6 hrs/day, 5 days/week, 3 weeks) of Intensive Hand Therapy (constraint therapy).
During bimanual therapy, children will actively use both hand in therapy.
Therapy will involve playing games, practicing activities of daily living, doing arts and crafts, and practicing repetitive hand movements.
During constraint therapy, children will wear a mitt over their less-impaired hand and actively use their more-impaired hand in therapy.
Therapy will involve playing games, practicing activities of daily living, doing arts and crafts, and practicing repetitive hand movements.
|
Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive bimanual hand therapy, which involves actively using both hands in play-based activities, games, arts and crafts, and activities of daily living.
The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive constraint therapy, which involves actively using the impaired hand in play-based activities, games, arts and crafts, and activities of daily living.
The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Assisting Hand Assessment after therapy
Time Frame: Day 1 of Intervention and day 180 of intervention
|
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
|
Day 1 of Intervention and day 180 of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Assisting Hand Assessment after therapy follow-up
Time Frame: Day 1 of Intervention and two months after last day of intervention
|
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
|
Day 1 of Intervention and two months after last day of intervention
|
Change in Assisting Hand Assessment after each three-week block of therapy
Time Frame: Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention
|
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
|
Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIMT-HABIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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