Recruiting

Constraint & Bimanual Therapy

Sponsor:

Blythedale Children's Hospital

Code:

NCT02840643

Conditions

Hemiplegia

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Bimanual hand therapy

Constraint therapy

Study Details

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

Study ID

NCT02840643

Start date

Jul, 2011

Status verified date

Jan, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • Change in Assisting Hand Assessment after therapy [ Time Frame: Day 1 of Intervention and day 180 of intervention ]

Central Contacts and Locations

Central contacts

Kelly Au, OTR/L

914-831-2459kellya@blythedale.org

Locations

Blythedale Children's Hospital

Recruiting

Valhalla, New York, United States, 10595

Contacts

Kelly Au, OTR/L

914-831-2459kellya@blythedale.org

Principal Investigator:

Kelly Au, OTR/L

More Information

Sponsor

Blythedale Children's Hospital

Last update posted

Jan 10, 2022

Last verified

Jan, 2022

Keywords

  • hemispherectomy
  • brain
  • hand function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blythedale Children's Hospital on 2022-01-10.