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

NCT ID: NCT02840643

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2023-12-31

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.

Conditions

Hemiplegia; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bimanual hand therapy

Intervention Type: BEHAVIORAL

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.

Constraint therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Bimanual hand therapy

Intervention Type: BEHAVIORAL

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.

Constraint therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blythedale Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Blythedale Children's Hospital

Valhalla, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly Au, OTR/L

Role: CONTACT

kellya@blythedale.org

914-831-2459

Facility Contacts

Kelly Au, OTR/L

Role: primary

kellya@blythedale.org

914-831-2459

Other Identifiers

CIMT-HABIT

Identifier Type: -

Identifier Source: org_study_id