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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Hemiplegia; Unilateral Cerebral Palsy
• Intervention / Treatment: Device: Neuromuscular electrical stimulation; Behavioral: Modified constraint induced movement therapy; Behavioral: Standard care for infant with asymmetrical hand function

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • Children's Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 10 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants with asymmetrical hand function

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: NMES; 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.; Other Names: mCIMT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Kathy Grinde
• Investigators: Principal Investigator: Kathy S Grinde, PT, Children's Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: early intervention; infant; cerebral palsy; constraint induced movement therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis; Hemiplegia
• Other Study ID Numbers: infantconstraint2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes