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

NCT ID: NCT05134272

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2023-05-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mCIMT plus NMES

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.

Neuromuscular electrical stimulation

Intervention Type: DEVICE

Neuromuscular Electrical Stimulation will be applied by the therapist to infant's finger flexors and extensor for 15 min./day, 3x/week.

Modified constraint induced movement therapy

Intervention Type: BEHAVIORAL

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.

Standard care for infant with asymmetrical hand function

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

NMES; mCIMT

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 10 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathy Grinde

OTHER

Sponsor Role: lead

Responsible Party

Kathy Grinde

Physical Therapist, Rehab Clinical Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathy S Grinde, PT

Role: PRINCIPAL_INVESTIGATOR

Children's Minnesota

Locations

Children's Minnesota

Maple Grove, Minnesota, United States

Countries

United States

Other Identifiers

infantconstraint2021

Identifier Type: -

Identifier Source: org_study_id