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

Kathy Grinde

Status: Completed

Conditions: Cerebral Palsy; Hemiplegia; Unilateral Cerebral Palsy

Treatments: Behavioral: Modified constraint induced movement therapy; Behavioral: Standard care for infant with asymmetrical hand function; Device: Neuromuscular electrical stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT05134272

infantconstraint2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 7 to 10 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Infant is 7-10 months of age (CCA)
2. Clinical presentation of asymmetrical hand function,
3. Grade 2/5 movement in more impaired upper extremity,
4. Demonstrate potential to participate in 6 hours of therapy/week during 3 week episode of mCIMT-NMES, as determined by principal investigator,
5. Parent/guardian willing to be partners in study and participate in follow-up assessments until child is 18 months of age

Exclusion criteria

1. Medical or sensory condition that prevents full therapy participation (active seizures, significant visual impairment)
2. Received Botox injection to more impaired upper extremity within last 6 months,
3. NMES contraindicated (impaired skin integrity, presence of pacemaker, clotting disorder),
4. Previous UE surgery or nerve injury (brachial plexus)

Trial design

5 participants in 1 patient group

mCIMT plus NMES

Description:

Phase 1: Infants will receive therapy 1 hour/day, 1 day/week for 3 weeks while wearing a sock 1 hour/day. Parents will complete home program activities 1 hour/day, 6 days/week for 3 weeks. Phase 2:Infants will receive therapy 2 hours/day, 3 days/week for 3 weeks while wearing a splint 24 hours/day. Parents will complete home program activities 1 hour/day, 6 days/week for 3 weeks. Phase 3:Infants will receive therapy 1 hour/day, 1 day/week for 3 weeks while wearing a sock 1 hour/day. Parents will complete home program activities 1 hour/day, 6 days/week for 3 weeks.

Treatment:

Device: Neuromuscular electrical stimulation

Behavioral: Standard care for infant with asymmetrical hand function

Behavioral: Modified constraint induced movement therapy