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Trial registered on ANZCTR


Registration number
ACTRN12613000690752
Ethics application status
Approved
Date submitted
16/06/2013
Date registered
24/06/2013
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of functional splinting combined with motor training to improve upper limb function in children with cerebral palsy and brain injury: A randomised controlled trial
Scientific title
Effectiveness of functional splinting combined with motor training to improve upper limb function in children with cerebral palsy and brain injury: A randomised controlled trial
Secondary ID [1] 263038 0
Nil
Universal Trial Number (UTN)
U1111-1124-5330
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand function in children with neurological conditions 270767 0
Condition category
Condition code
Neurological 270949 270949 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a 3 group randomised controlled trial, comparing hand splinting combined with motor training, with hand splinting alone or motor training alone. Duration of the intervention will be 2 weeks, with outcome measures being taken immediately after intervention, and 10 weeks after baseline assessment. Group 1- Functional splint only A functional hand splint is an external device applied with the purpose of supporting the hand in an ideal position to complete an activity. In this group, participants will be provided with a hand splint that they will wear during activities over a 2 week period. It will be recommended that the splint be worn for 1 hour daily. Group 2 - Motor Training Only 'Motor training' is a rehabilitation intervention that involves task-specific, repititous activity that aims to induce changes in the neural pathways. For the purposes of this study, children will recieve a total of 10 intervention sessions, over a period of 2 weeks (10 x 1 hour training sessions, 5 times per week for 2 weeks). Children and their parents will be expected to practice those skills learnt in therapy sessions within the home environment for 1 hour daily. Group 3 Motor training combined with functional splinting - this intervention group will recieve a combination of functional splinting and motor training intervention. Participants will undergo 10 motor training sessions (10 x 1 hour training sessions, 5 times per week for 2 weeks), during which they will wear their functional hand splint. Children and their parents will be expected to practice those skills learnt in therapy sessions within the home environment for 1 hour daily (wearing their hand splint during this practice).
Intervention code [1] 269382 0
Rehabilitation
Intervention code [2] 269552 0
Treatment: Other
Comparator / control treatment
Functional splinting only - this group will receive a functional hand splint only. A functional hand splint is an external device applied with the purpose of supporting the hand in an ideal position to complete an activity. In this group, participants will be provided with a hand splint that they will wear during activities over a 2 week period. They will not receive face to face therapy. The splint only group is considered the control group for this trial as it was deemed unethical to provide no treatment to a group of participants.
Control group
Active

Outcomes
Primary outcome [1] 279625 0
Canadian Occupational Performance Measure
Timepoint [1] 279625 0
At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation
Secondary outcome [1] 294072 0
The Goal Attainment Scale (GAS)
Timepoint [1] 294072 0
At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation
Secondary outcome [2] 294073 0
The Box & Blocks Test
Timepoint [2] 294073 0
At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation

Group 1 (splint only) and group 2 (motor training only) will complete the box and blocks test 1 hour following baseline to obtain data on the immediate effect of a functional hand splint, compared to no hand splint.
Secondary outcome [3] 294074 0
Active range of motion and passive range of motion of wrist extension (measurements to be taken with a digital inclinometer). This will include with fingers extended (Volkmann's angle)
Timepoint [3] 294074 0
At baseline, 2 weeks after randomisation (following 2 week treatment block), at 10 weeks after randomisation
Secondary outcome [4] 294076 0
House thumb classification collected at baseline only, to be used as initial participant data rather than an outcome measure.
Timepoint [4] 294076 0
At baseline only

Eligibility
Key inclusion criteria
1. Diagnosis of a Cerebral Palsy or a Brain Injury
2. Impaired upper limb function as a result of the neurological condition
3. Restricted wrist range of motion/position of wrist impacting on ability to use hand effectively
4. Therapy goals related to hand function
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Manual Ability Classification Scale (MACS) level V (The MACS classifies a child's ability to use their hands for functional activities on a daily basis. MACS is a spectrum of I - V, with I being lest severe, and level V being most severe. Children who are classified as MACS level V require total assistance, and do not have the ability to actively use their hands for functionals tasks. Hence, in standard practice, these children would not be seen as candidates for the interventions being utilised in this study)

2. Known allergy to thermoplastic splinting material

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified through services that are currently supporting this population. Participants who express an interest in this research will be contacted by the research team, to discuss the full details of the research, including treatment groups, committment required, timeframe and ethical considerations. All participants who meet the study criteria, and whose parents consent to participation in the study, will be enrolled in the study until the study is filled.
After informed consent and baseline measures are taken, participants will be randomised by an officer not connected with the study and at a separate location using a pre-prepared random assignment schedule stored within concealed opaque envelopes generated using computer generated random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by an officer not connected with the study and at a separate location using a pre-prepared random assignment schedule stored within concealed opaque envelopes generated using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were estimated using data from a like study, based on data analysis using multiple regression. A sample size of 15 children per group will give an 80% probability of detecting an effect of 2 points on the 10-point COPM scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2012
Actual
23/09/2013
Date of last participant enrolment
Anticipated
Actual
24/01/2016
Date of last data collection
Anticipated
Actual
24/04/2016
Sample size
Target
45
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 7820 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 7821 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 4516 0
2280
Recruitment postcode(s) [2] 4517 0
2290
Recruitment postcode(s) [3] 4518 0
2300
Recruitment postcode(s) [4] 4519 0
2310
Recruitment postcode(s) [5] 4520 0
2320
Recruitment postcode(s) [6] 15753 0
4101 - South Brisbane
Recruitment postcode(s) [7] 15754 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 269894 0
Self funded/Unfunded
Name [1] 269894 0
Michelle Jackman
Country [1] 269894 0
Australia
Funding source category [2] 289025 0
Government body
Name [2] 289025 0
NHMRC
Country [2] 289025 0
Australia
Primary sponsor type
University
Name
University of Notre Dame
Address
Assoc Prof Iona Novak
Faculty of Medicine
PO Box 560
Darlinghurst NSW 1300
Country
Australia
Secondary sponsor category [1] 268907 0
Hospital
Name [1] 268907 0
Alfred Health
Address [1] 268907 0
Assoc Prof Natasha Lannin
Occupational Therapy Department
The Alfred
PO Box 315
Prahan
VIC 3181
Country [1] 268907 0
Australia
Other collaborator category [1] 252258 0
Charities/Societies/Foundations
Name [1] 252258 0
Cerebral Palsy Alliance
Address [1] 252258 0
Research Institute of Cerebral Palsy Alliance
PO Box 560
Darlinghurst NSW 1300
Country [1] 252258 0
Australia
Other collaborator category [2] 252259 0
Hospital
Name [2] 252259 0
Kaleidoscope Children's Services / John Hunter Children's Hospital
Address [2] 252259 0
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country [2] 252259 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271865 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 271865 0
Ethics committee country [1] 271865 0
Australia
Date submitted for ethics approval [1] 271865 0
28/10/2011
Approval date [1] 271865 0
13/03/2012
Ethics approval number [1] 271865 0
EC00403
Ethics committee name [2] 271866 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [2] 271866 0
Ethics committee country [2] 271866 0
Australia
Date submitted for ethics approval [2] 271866 0
25/11/2011
Approval date [2] 271866 0
16/07/2012
Ethics approval number [2] 271866 0
EC00418
Ethics committee name [3] 271867 0
The Cerebral Palsy Alliance Human Research Ethics Committee
Ethics committee address [3] 271867 0
Ethics committee country [3] 271867 0
Australia
Date submitted for ethics approval [3] 271867 0
25/11/2011
Approval date [3] 271867 0
02/02/2012
Ethics approval number [3] 271867 0
EC00402
Ethics committee name [4] 297406 0
Monash Health
Ethics committee address [4] 297406 0
Ethics committee country [4] 297406 0
Australia
Date submitted for ethics approval [4] 297406 0
30/06/2014
Approval date [4] 297406 0
19/08/2014
Ethics approval number [4] 297406 0
14232B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33153 0
Ms Michelle Jackman
Address 33153 0
Paediatric Occupational Therapy Department
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 33153 0
Australia
Phone 33153 0
+61 2 49213700
Fax 33153 0
Email 33153 0
michelle.jackman@hnehealth.nsw.gov.au
Contact person for public queries
Name 16400 0
Michelle Jackman
Address 16400 0
Paediatric Occupational Therapy Department
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 16400 0
Australia
Phone 16400 0
+61 2 49213700
Fax 16400 0
Email 16400 0
michelle.jackman@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 7328 0
Michelle Jackman
Address 7328 0
Paediatric Occupational Therapy Department
John Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 7328 0
Australia
Phone 7328 0
+61 2 49213700
Fax 7328 0
Email 7328 0
michelle.jackman@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Cognitive Orientation to dailyGOccupational Performance over and above functional hand splints for children with cerebral palsy or brain injury: A randomized controlled trial.2018https://dx.doi.org/10.1186/s12887-018-1213-9
EmbaseThe Cognitive Orientation to daily Occupational Performance (CO-OP) Approach: Best responders in children with cerebral palsy and brain injury.2018https://dx.doi.org/10.1016/j.ridd.2018.04.019
EmbaseImmediate effect of a functional wrist orthosis for children with cerebral palsy or brain injury: A randomized controlled trial.2019https://dx.doi.org/10.1016/j.jht.2017.09.006
N.B. These documents automatically identified may not have been verified by the study sponsor.