HemiplegiaNCT05134272
Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
An observational study of Hemiplegia and Cerebral Palsy, run by Kathy Grinde at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 months
- Conditions the study is for
- Hemiplegia, Cerebral Palsy, Unilateral Cerebral Palsy
- What is being tested?
- Neuromuscular electrical stimulation and Modified constraint induced movement therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants with asymmetrical hand function
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hemiplegia, Cerebral Palsy, Unilateral Cerebral Palsy
- Being tested
- Neuromuscular electrical stimulation, Modified constraint induced movement therapy, Standard care for infant with asymmetrical hand function
- Keywords
- infant, constraint induced movement therapy, early intervention, cerebral palsy
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Also called NMES
Neuromuscular Electrical Stimulation will be applied by the therapist to infant's finger flexors and extensor for 15 min./day, 3x/week.
Modified constraint induced movement therapyBehavioural
Also called mCIMT
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.
Standard care for infant with asymmetrical hand functionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neuromuscular electrical stimulation; Behavioral: Modified constraint induced movement therapy; Behavioral: Standard care for infant with asymmetrical hand function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, week 7, week 10
Secondary outcomes (2)
Change in motor skills based on the Peabody Developmental Motor Scales-2
A criterion and norm referenced test that measures fine and gross motor skill
Measured: Baseline, week 4, week 7, week 10, 18 months CCA
Assisting Hand Assessment Version 4.4
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.
Measured: 18 months CCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start17 Nov 2021
- Primary completion16 Nov 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathy Grinde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathy Grinde, Children's Hospitals and Clinics of Minnesota
- Investigators
- Kathy S Grinde, PT, Principal investigator, Children's Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134272
- Sponsor's protocol ID
- infantconstraint2021
- Status last verified
- Jun 2023
- First submitted
- 8 Nov 2021
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Modified Constraint Induced Movement Therapy Paired With Neuromuscular Electrical Stimulation: a Case Series
- ClinicalTrials.gov ID
- NCT05134272
- Acronym / sponsor ID
- infantconstraint2021
- Conditions
- Hemiplegia, Cerebral Palsy, Unilateral Cerebral Palsy
- Keywords
- infant, constraint induced movement therapy, early intervention, cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kathy GrindeUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCIMT plus NMES | – | Device: Neuromuscular electrical stimulation, Behavioral: Modified constraint induced movement therapy, Behavioral: Standard care for infant with asymmetrical hand functionPhase 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. |
Who may qualify
- Ages
- 7 to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with asymmetrical hand function
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAlso: NMESNeuromuscular Electrical Stimulation will be applied by the therapist to infant's finger flexors and extensor for 15 min./day, 3x/week. | Device | mCIMT plus NMES |
| Modified constraint induced movement therapyAlso: mCIMTModified 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. | Behavioural | mCIMT plus NMES |
| Standard care for infant with asymmetrical hand functionInfants 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. | Behavioural | mCIMT plus NMES |
Primary outcome
Change in hand use based on the Hand Assessment of Infants
Time frame: 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.
2 secondary outcomes
Change in motor skills based on the Peabody Developmental Motor Scales-2
Time frame: Baseline, week 4, week 7, week 10, 18 months CCA
Assisting Hand Assessment Version 4.4
Time frame: 18 months CCA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy S Grinde, PT principal investigator
Children's Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia and Cerebral Palsy, run by Kathy Grinde at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand use based on the Hand Assessment of Infants (time frame: Baseline, week 4, week 7, week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.