NCT02840643

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Blythedale Children's Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemiplegia
• Cerebral Palsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-07-21
• Last updated: 2022-01-10

Locations

1 site across 1 country: United States