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

NCT05134272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2023-06-27

No results posted yet for this 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.

Conditions

  • Hemiplegia
  • Cerebral Palsy
  • Unilateral Cerebral Palsy

Interventions

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.

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.

Sponsors & Collaborators

  • Kathy Grinde

    lead OTHER

Principal Investigators

  • Kathy S Grinde, PT · Children's Minnesota

Eligibility

Min Age
7 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-11-16
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134272 on ClinicalTrials.gov