Clinical trial NCT05134272: Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
Official title: Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegia
Cerebral Palsy
Unilateral Cerebral Palsy
Keywords: infant
constraint induced movement therapy
early intervention
cerebral palsy
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 5
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with asymmetrical hand function

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in hand use based on the Hand Assessment of Infants
timeFrame: Baseline, week 4, week 7, week 10
Secondary outcomes:
measure: Change in motor skills based on the Peabody Developmental Motor Scales-2
timeFrame: Baseline, week 4, week 7, week 10, 18 months CCA
measure: Assisting Hand Assessment Version 4.4
timeFrame: 18 months CCA
Other outcomes:
Locations:
city: Maple Grove
country: United States
facility: Children's Minnesota
state: Minnesota
Study officials:
affiliation: Children's Minnesota
name: Kathy S Grinde, PT
role: PRINCIPAL_INVESTIGATOR
References: