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

NCT02840643 | Unknown

• 1 other identifier: CIMT-HABIT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Cerebral Palsy

Keywords

hemispherectomy; brain; hand function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Assisting Hand Assessment after therapy follow-up

  Day 1 of Intervention and two months after last day of intervention

• Change in Assisting Hand Assessment after each three-week block of therapy

  Day 1 of Intervention, end of third week of intervention, and end of sixth week of intervention

Study Arms (2)

Constraint Therapy and Bimanual Therapy

EXPERIMENTAL

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.

Behavioral: Bimanual hand therapy; Behavioral: Constraint therapy

Bimanual Therapy and Constraint Therapy

EXPERIMENTAL

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.

Behavioral: Bimanual hand therapy; Behavioral: Constraint therapy

Interventions

Bimanual hand therapy 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.

Bimanual Therapy and Constraint Therapy; Constraint Therapy and Bimanual Therapy

Constraint therapy 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; Constraint Therapy and Bimanual Therapy

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Uncorrected vision problems.
• Inability to communicate or follow directions.

Sponsors & Collaborators

• Blythedale Children's Hospital: lead

Study Sites (1)

Blythedale Children's Hospital

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Central Study Contacts

Kelly Au, OTR/L

CONTACT

914-831-2459; kellya@blythedale.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: July 1, 2011
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

US (1)