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

Last updated: June 26, 2023
Sponsor: Kathy Grinde
Overall Status: Completed

Phase

N/A

Condition

Limb Spasticity

Cerebral Palsy

Cataplexy

Treatment

Modified constraint induced movement therapy

Standard care for infant with asymmetrical hand function

Neuromuscular electrical stimulation

Clinical Study ID

NCT05134272
infantconstraint2021
  • Ages 7-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 episodeof mCIMT-NMES, as determined by principal investigator,
  5. Parent/guardian willing to be partners in study and participate in follow-upassessments until child is 18 months of age

Exclusion

Exclusion Criteria:

  1. Medical or sensory condition that prevents full therapy participation (activeseizures, 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, clottingdisorder),
  4. Previous UE surgery or nerve injury (brachial plexus)

Study Design

Total Participants: 5
Treatment Group(s): 3
Primary Treatment: Modified constraint induced movement therapy
Phase:
Study Start date:
November 17, 2021
Estimated Completion Date:
May 31, 2023

Study 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.

Connect with a study center

  • Children's Minnesota

    Maple Grove, Minnesota 55369
    United States

    Site Not Available

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