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

Sponsor
Kathy Grinde (Other)
Overall Status
Recruiting
CT.gov ID
NCT05134272
Collaborator
(none)
5
1
17.9
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
5 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in hand use based on the Hand Assessment of Infants [Baseline, week 4, week 7, week 10]

      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.

    Secondary Outcome Measures

    1. Change in motor skills based on the Peabody Developmental Motor Scales-2 [Baseline, week 4, week 7, week 10, 18 months CCA]

      A criterion and norm referenced test that measures fine and gross motor skill

    2. Assisting Hand Assessment Version 4.4 [18 months CCA]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Months to 10 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Minnesota Maple Grove Minnesota United States 55369

    Sponsors and Collaborators

    • Kathy Grinde

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kathy Grinde, Physical Therapist, Rehab Clinical Specialist, Children's Hospitals and Clinics of Minnesota
    ClinicalTrials.gov Identifier:
    NCT05134272
    Other Study ID Numbers:
    • infantconstraint2021
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Kathy Grinde, Physical Therapist, Rehab Clinical Specialist, Children's Hospitals and Clinics of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 24, 2021