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

NCT05134272 | Completed FDA Device

• 1 other identifier: infantconstraint2021
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Cerebral Palsy; Unilateral Cerebral Palsy

Keywords

infant; constraint induced movement therapy; early intervention; cerebral palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in motor skills based on the Peabody Developmental Motor Scales-2

  Baseline, week 4, week 7, week 10, 18 months CCA

• Assisting Hand Assessment Version 4.4

  18 months CCA

Study Arms (1)

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; Behavioral: Modified constraint induced movement therapy; Behavioral: Standard care for infant with asymmetrical hand function

Interventions

Neuromuscular electrical stimulation DEVICE

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

Also known as: NMES

mCIMT plus NMES

Modified constraint induced movement therapy 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.

Also known as: mCIMT

mCIMT plus NMES

Standard care for infant with asymmetrical hand function 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.

mCIMT plus NMES

Eligibility Criteria

• Age: 7 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with asymmetrical hand function

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kathy Grinde: lead

Study Sites (1)

Children's Minnesota

Maple Grove, Minnesota, 55369, United States

Location

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kathy S Grinde, PT

  Children's Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist, Rehab Clinical Specialist

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 24, 2021
• Study Start: November 17, 2021
• Primary Completion: November 16, 2022
• Study Completion: May 31, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)