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Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury

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ClinicalTrials.gov Identifier: NCT02840643
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Blythedale Children's Hospital

Brief Summary:
To examine efficacy of combined unimanual and bimanual intensive therapy in children with unilateral brain injury. A key question in hemiplegia therapy is whether the affected hand should be trained alone or in tandem with the other hand. In constraint-induced movement therapy (CIMT), a participant's less-affected upper extremity is restricted with a sling, cast, or mitt, while the participant actively uses the affected arm and hand in skill-based therapeutic activities. Bimanual therapy, in contrast, engages both hands in therapeutic movement. Since constraint and bimanual therapy target different aspects of hand use, they could have synergistic effects on hand function when given in combination.

Condition or disease Intervention/treatment Phase
Hemiplegia Cerebral Palsy Behavioral: Bimanual hand therapy Behavioral: Constraint therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury
Study Start Date : July 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.
Behavioral: Bimanual hand therapy
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.

Behavioral: Constraint therapy
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.
Behavioral: Bimanual hand therapy
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.

Behavioral: Constraint therapy
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840643


Contacts
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Contact: Kelly Au, OTR/L 914-831-2459 kellya@blythedale.org

Locations
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United States, New York
Blythedale Children's Hospital Recruiting
Valhalla, New York, United States, 10595
Contact: Kelly Au, OTR/L    914-831-2459    kellya@blythedale.org   
Sub-Investigator: Sue McGinty, OTR/L         
Sub-Investigator: Julie Knitter, OTR/L         
Sub-Investigator: Kathleen M Friel, PhD         
Principal Investigator: Kelly Au, OTR/L         
Sponsors and Collaborators
Blythedale Children's Hospital
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Responsible Party: Blythedale Children's Hospital
ClinicalTrials.gov Identifier: NCT02840643    
Other Study ID Numbers: CIMT-HABIT
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Blythedale Children's Hospital:
hemispherectomy
brain
hand function
Additional relevant MeSH terms:
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Brain Injuries
Cerebral Palsy
Hemiplegia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Paralysis
Neurologic Manifestations