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Minimising impairment: A multicentre randomized controlled trial of upper limb orthoses for children with cerebral palsy.

Does wearing a rigid upper limb wrist hand orthosis in combination with evidence informed occupational therapy, compared to evidence informed occupational therapy alone, reduce wrist/hand impairment and improve activity and participation outcomes in children aged 5-15 years with cerebral palsy?

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001276640
Acronym
Minimising impairment trial
Enrollment
74
Registered
2014-12-05
Start date
2015-08-28
Completion date
2017-12-01
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for children with cerebral palsy. This trial aims to maintain and/or increase range of movement in the wrist thumb and fingers of children aged 5-15 years.

Interventions

The treatment group will receive a custom-made serially adjustable rigid wrist/hand orthosis (WHO) to maintain the flexor compartment (muscles of the wrist, fingers and thumb) in a lengthened position to avoid shortening of the musculo-tendinous unit and other soft tissue. Children will be asked to wear the splint overnight, or for a minimum of 6 hours during the night or day (nightly/daily), for the three years of the study, to achieve a prolonged positioning effect with the orthosis. Althoug

The treatment group will receive a custom-made serially adjustable rigid wrist/hand orthosis (WHO) to maintain the flexor compartment (muscles of the wrist, fingers and thumb) in a lengthened position to avoid shortening of the musculo-tendinous unit and other soft tissue. Children will be asked to wear the splint overnight, or for a minimum of 6 hours during the night or day (nightly/daily), for the three years of the study, to achieve a prolonged positioning effect with the orthosis. Although night time wear is recommended, for some children it may be appropriate to wear the orthosis during the day. An App (iPhone and android compatible) will be used to monitor factors such as the use of orthoses and any adverse events, based on parent report. Parents will receive a weekly text-reminder to record therapy received in the past week using simple response formats. Data recorded on the App will be supplemented through a 6-monthly parent interview conducted by the site based research assistant to record additional details about the usual evidence-informed therapy their child received in the preceding period. All children (regardless of group allocation) will receive care typically provided by their usual treating organisation. Possible treatments may include developmentally appropriate, goal focused and evidence-informed occupational therapy, the use of equipment or BoNT-A injections.

Sponsors

Christine Imms
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

A confirmed diagnosis of cerebral palsy as recorded in the medical history; Aged 5-15 years; Presence of flexor muscle stiffness - score at least 1 on the Modified Ashworth Scale during wrist extension with fingers extended; May or may not already exhibit contracture at the wrist.

Exclusion criteria

Dystonic, rather than spastic, motor disorder; Allergy/sensitivity to splinting material; Upper limb surgery during the study period or in the 12 months preceding study commencement; Significant child refusal to comply with splint wearing schedule; Family inability to access the study assessment or treatment site (due to geography).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026