Clinical trial NCT02840643: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia
Cerebral Palsy
Keywords: hemispherectomy
brain
hand function
Lead sponsor: Blythedale Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Assisting Hand Assessment after therapy
timeFrame: Day 1 of Intervention and day 180 of intervention
Secondary outcomes:
measure: Change in Assisting Hand Assessment after therapy follow-up
timeFrame: Day 1 of Intervention and two months after last day of intervention
measure: Change in Assisting Hand Assessment after each three-week block of therapy
timeFrame: Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Blythedale Children's Hospital
state: New York
Study officials:
References: