NCT05533476

Brief Summary

A pilot randomized clinical trial exploring the effect of a Multi Sensory Stimulation And Priming (MuSSAP) training on improving manual ability in infants at risk of developing unilateral Cerebral Palsy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

September 5, 2022

Last Update Submit

October 27, 2022

Conditions

Unilateral Cerebral Palsy

Keywords

Cerebral PalsyMultisensory StimulationHand functionInfantsEarly intervention

Outcome Measures

Primary Outcomes (2)

  • Mean change from T0 in manual ability as assessed by the Hand Assessment for Infants (HAI)

    The HAI is intended to evaluate the quality of goal-directed manual actions in infants, 3-12 months of age, at risk of developing unilateral CP. The test procedure comprises a semi-structured video-recorded 10-15-min play session. HAI is intended to detect and quantify possible asymmetry between hands by providing scores for each hand separately (Each Hand sum Score (EaHS) (range 0-24)), and to provide a measure of bilateral hand use (Both Hands Measure (BoHM) (range 0-100)) with a higher score reflecting a better outcome.

    T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)

  • Adherence based on total training time

    Parents fill out a digital time registration form to assess intervention adherence every day. Adherence will be calculated by dividing the registrated total training time by total planned training time (28 hours).

    During 8 week intervention

Secondary Outcomes (4)

  • Motor development as assessed by the Bayley Scales of Infant and Toddler Development - Third Edition (Dutch version) (Bayley-III-NL)

    T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)

  • Gross motor development as assessed by the Gross Motor Function Measure (GMFM)

    T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)

  • Quality of life as assessed by the Infant and Toddler Quality of life Questionnaire (ITQOL)

    T0 (before the start of the intervention), T1 (after the 8-week intervention), T2 (8 weeks after the interventions stops)

  • Reaction time of self-initiated goal-directed movement and attention as assessed by the Video Observation Attention Affected Hand (VOAAH)

    During 8 week intervention

Study Arms (2)

Multi Sensory Stimulation And Priming

EXPERIMENTAL

8 weeks, 30 minutes per day home based MuSSAP training.

Behavioral: Multi Sensory Stimulation and Priming

Intensive Usual Care (Upper Limb)

EXPERIMENTAL

8 weeks, 30 minutes per day home based Intensive Usual Care (Upper Limb).

Behavioral: Intensive Usual Care (Upper Limb)

Interventions

Multi Sensory Stimulation and PrimingBEHAVIORAL

In the MuSSAP intervention group, the infant wears a multisensory stimulating wristband aiming at increasing attention for the affected upper limb and readiness to initiate a goal-directed movement. Parents are instructed to present a toy to their child if the child shows attention to the affected arm and hand. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.

Multi Sensory Stimulation And Priming
Intensive Usual Care (Upper Limb)BEHAVIORAL

The Intensive Usual Care (Upper Limb) intervention is a more intensive (in duration and frequency) version of standard Usual Care with focus on the motor development of the affected upper extremity. Upper extremity motor activities like reaching, grasping and holding are practiced. Parents practice daily and once a week the training will be guided or conducted by a physical or occupational therapist in the home environment. An occupational therapist from the rehabilitation center will coach parents during the intervention period through the internet, by means of analyzing the videos from the home training.

Intensive Usual Care (Upper Limb)

Eligibility Criteria

Age4 Months - 10 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born preterm suffering from unilateral periventricular haemorrhagic infarction with involvement of the corticospinal tracts
  • Born term suffering from unilateral middle cerebral artery stroke with involvement of the corticospinal tracts
  • ±4 months of age (time the infant starts to reach with at least one hand) to 10 months of age (age corrected in case of prematurity)

You may not qualify if:

  • Severe epilepsy
  • Severe sensory impairments (blindness, deafness)
  • Children with clinical signs of bilateral involvement
  • Inability of parents to respond to interviews or questionnaires in Dutch
  • Expected inability of parents to adhere to the home-based protocol
  • Born term (≥37 weeks gestational age)
  • Birth weight within a normal range (≥2500 grams)
  • Inability of parents to respond to interviews or questionnaires in Dutch
  • Expected inability of parents to adhere to planned measuring moments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Verhaegh AP, Nuijen NB, Aarts PB, Nijhuis-van der Sanden MWG, Willemsen MA, Groen BE, Vriezekolk JE. Parents' experiences with a home-based upper limb training program using a video coaching approach for infants and toddlers with unilateral cerebral palsy: a qualitative interview study. BMC Pediatr. 2022 Jun 29;22(1):380. doi: 10.1186/s12887-022-03432-w.

    PMID: 35768858BACKGROUND

  • Verhaegh APM, Groen BE, Aarts PBM, van Ee R, Willemsen MAAP, Jongsma MLA, Nijhuis-van der Sanden MWG. Multisensory Stimulation and Priming (MuSSAP) in 4-10 Months Old Infants with a Unilateral Brain Lesion: A Pilot Randomised Clinical Trial. Occup Ther Int. 2023 Jan 6;2023:8128407. doi: 10.1155/2023/8128407. eCollection 2023.

    PMID: 36711188DERIVED

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pauline Aarts, PhD

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 9, 2022

Study Start

June 14, 2016

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share