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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840643
• Other study ID #: CIMT-HABIT
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Blythedale Children's Hospital
• Contact: Kelly Au, OTR/L
• Phone: 914-831-2459
• Email: kellya[@]blythedale.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Hemiplegia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Blythedale Children's Hospital	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Blythedale Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Assisting Hand Assessment after therapy	The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.	Day 1 of Intervention and day 180 of intervention
Secondary	Change in Assisting Hand Assessment after therapy follow-up	The Assisting Hand Assessment (AHA) measures how well children use both hands in bimanual activities.	Day 1 of Intervention and two months after last day of intervention
Secondary	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.	Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention