NCT05134272

Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Kathy Grinde · Academic / Other
• Sex: All
• Age: 7 Months – 10 Months
• Healthy volunteers: Not accepted

Summary

This study will compare the motor outcomes for five infants with asymmetrical hand function (AHF) who will receive two, three week episodes of standard care separated by a three week episode of mCIMT paired with Neuromuscular Electrical Stimulation. The results of this study will inform decisions on the feasibility and efficacy of the treatment for use in a larger study for infants with AHF at risk for unilateral cerebral palsy.

Detailed description

Infants with asymmetrical hand function will participate in three consecutive phases of treatment. The first and third phase will consist of three weeks of standard care for children with asymmetrical hand function, 1 hour/day, 1 day/week. The therapist will provide weekly coaching with the parents so they can carry over activities at home one hour/day, six days/week during this phase. In addition, a sock or mitten will be used for short term constraint during the hour of training both in the clinic with the therapist and at home with the parent. The second phase will consist of three weeks of modified constraint induced movement therapy, 2 hours/day, 3 days/week paired with NMES, 15 minutes/day, 3 days/week. The infants will wear a soft splint on their preferred hand and forearm 24 hours/day during this phase. Parents will be trained by the therapist to carry over activities with their child at home, 1 hour/day, 6 days/week. The children will return at chronological age of 18 months for follow up testing.

Conditions

• Hemiplegia
• Cerebral Palsy
• Unilateral Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Neuromuscular electrical stimulation	Neuromuscular Electrical Stimulation will be applied by the therapist to infant's finger flexors and extensor for 15 min./day, 3x/week.
BEHAVIORAL	Modified constraint induced movement therapy	Modified CIMT will consist of constraint 24 hours/day using a splint in addition to therapy two hours/day, 3x/week for three weeks. Parents will be trained to carry over home program activities one hour/day, 6 days/week.
BEHAVIORAL	Standard care for infant with asymmetrical hand function	Infants will receive one hour of therapy, one time/week for three weeks. Parents will be trained to carry over home program activities one hour/day, 6 days/week. In addition the infant will wear a sock on their preferred hand during the hour of therapy/home program activity.

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-11-16
• Completion: 2023-05-31
• First posted: 2021-11-24
• Last updated: 2023-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study