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

Primary Purpose

Hemiplegia, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bimanual hand therapy
Constraint therapy
Sponsored by
Blythedale Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring hemispherectomy, brain, hand function

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Blythedale Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Constraint Therapy and Bimanual Therapy

Bimanual Therapy and Constraint Therapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in Assisting Hand Assessment after therapy
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.

Secondary Outcome Measures

Change in Assisting Hand Assessment after therapy follow-up
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
Change in Assisting Hand Assessment after each three-week block of therapy
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.

Full Information

First Posted
July 19, 2016
Last Updated
January 5, 2022
Sponsor
Blythedale Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02840643
Brief Title
Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury
Official Title
Combined Constraint Therapy and Bimanual Therapy for Children With Unilateral Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blythedale Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Cerebral Palsy
Keywords
hemispherectomy, brain, hand function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constraint Therapy and Bimanual Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Bimanual Therapy and Constraint Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bimanual hand therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Constraint therapy
Intervention Description
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 Measure Information:
Title
Change in Assisting Hand Assessment after therapy
Description
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
Time Frame
Day 1 of Intervention and day 180 of intervention
Secondary Outcome Measure Information:
Title
Change in Assisting Hand Assessment after therapy follow-up
Description
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
Time Frame
Day 1 of Intervention and two months after last day of intervention
Title
Change in Assisting Hand Assessment after each three-week block of therapy
Description
The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.
Time Frame
Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Au, OTR/L
Phone
914-831-2459
Email
kellya@blythedale.org
Facility Information:
Facility Name
Blythedale Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Au, OTR/L
Phone
914-831-2459
Email
kellya@blythedale.org
First Name & Middle Initial & Last Name & Degree
Sue McGinty, OTR/L
First Name & Middle Initial & Last Name & Degree
Julie Knitter, OTR/L
First Name & Middle Initial & Last Name & Degree
Kathleen M Friel, PhD
First Name & Middle Initial & Last Name & Degree
Kelly Au, OTR/L

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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