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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134272
• Other study ID #: infantconstraint2021
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 31, 2023
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months to 10 Months

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia
• Paralysis
• Unilateral Cerebral Palsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Minnesota	Maple Grove	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Kathy Grinde

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hand use based on the Hand Assessment of Infants	A criterion, norm referenced assessment that evaluates and measures goal directed both hand use and possible upper limb asymmetry in infants at risk of developing cerebral palsy,aged 3-12 months.	Baseline, week 4, week 7, week 10
Secondary	Change in motor skills based on the Peabody Developmental Motor Scales-2	A criterion and norm referenced test that measures fine and gross motor skill	Baseline, week 4, week 7, week 10, 18 months CCA
Secondary	Assisting Hand Assessment Version 4.4	A criterion-referenced test that measures and describes how effectively children who have unilateral disability, aged 18 months to 12 years, use their affected hand in bimanual activity performance.	18 months CCA