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Trial registered on ANZCTR


Registration number
ACTRN12612001060831
Ethics application status
Approved
Date submitted
28/09/2012
Date registered
4/10/2012
Date last updated
22/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treadmill Training in Infants At-Risk for Neuromotor Delay
Scientific title
Infants at risk for neurodevelopmental delay with and without treadmill training: frequency of alternating steps and toe contacts
Secondary ID [1] 281243 0
Nil
Universal Trial Number (UTN)
U1111-1134-8321
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant born with low birth weight (<1500g). 287491 0
Periventricular leukomalacia. 287494 0
Hypoxic-ischemic encephalopathy. 287495 0
Neonatal seizures. 287496 0
Neurodevelopmental delay. 287560 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287822 287822 0 0
Physiotherapy
Neurological 287884 287884 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treadmill training; frequency: 5 days/week; duration: 8 minutes/session; belt speed: 0.2m/s.
The intervention started when infants were able to produce 10 supported steps on a treadmill within 1 minute trial (as long as it happened before turning 13 months corrected age, if they were to be included in this study). Treadmill training continued until the infant was observed walking 3 independent steps over ground, or the infant turned 24 months corrected age.
Intervention code [1] 285756 0
Treatment: Devices
Intervention code [2] 285757 0
Rehabilitation
Comparator / control treatment
The control group did not receive treadmill training. All families were visited on a monthly basis to videotape five 1-minute trials of the infants stepping while being supported on a treadmill.
Control group
Active

Outcomes
Primary outcome [1] 288044 0
Primary outcome 1: Age of onset of independent walking.
Timepoint [1] 288044 0
Timepoint: whenever families reported their infants being able to take 3 steps over ground.
Primary outcome [2] 288045 0
Primary outcome 2: percent of alternating steps.
Timepoint [2] 288045 0
Timepoint: monthly from starting the training or entering the study until walking onset (termination of intervention), and 6 months follow-up for gait analysis.
Primary outcome [3] 288046 0
Primary outcome 3: percent of toe contact (Video analysis of foot placement at the initiation of the stance phase in the treadmill step).
Timepoint [3] 288046 0
Timepoint: monthly from starting the training or entering the study until walking onset (termination of intervention), and 6 months follow-up for gait analysis.
Secondary outcome [1] 299331 0
Secondary outcome 1: Gross Motor Function Measure
Timepoint [1] 299331 0
Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.
Secondary outcome [2] 299379 0
Secondary outcome 2: Motor development (Bayley motor)
Timepoint [2] 299379 0
Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.
Secondary outcome [3] 299380 0
Secondary outcome 3: Cognitive development (Bayley mental)
Timepoint [3] 299380 0
Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.
Secondary outcome [4] 299381 0
Secondary outcome 4: Spasticity (Ashworth)
Timepoint [4] 299381 0
Timepoint: Termination of the intervention: when the infant was observed walking 3 independent steps over ground. Same timepoint for the control group.

Eligibility
Key inclusion criteria
Mild to moderate hypo/hypertonia or developmental delay when examined by their pediatrician; no congenital musculoskeletal deficits or other genetic disorders.
Minimum age
6 Months
Maximum age
13 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe hypo/hypertonia, genetic disorders such as spina bifida or Down syndrome, and genetic musculoskeletal deficits.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment via high risk clinics of local hospital, doctors referred potential subjects, and after checking exclusion/inclusion criteria, the assigned ID was entreted into a computer program for group allocation by a statistician unaware to which group the subject would be allocated (central randomisation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted via a computer program considering 3 stratification factors: age, gender, birth weight
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4560 0
United States of America
State/province [1] 4560 0

Funding & Sponsors
Funding source category [1] 286075 0
Government body
Name [1] 286075 0
Office of Special Education and Rehabilitation Services
Country [1] 286075 0
United States of America
Primary sponsor type
University
Name
Michigan University
Address
401 Washtenaw Ave
Ann Arbor, MI 48109
Country
United States of America
Secondary sponsor category [1] 284891 0
University
Name [1] 284891 0
University of Barcelona - INEFC
Address [1] 284891 0
Avda de l'Estadi 12-22
08038 Barcelona
Country [1] 284891 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288103 0
Institutional Review Board, University of Michigan Medical Center
Ethics committee address [1] 288103 0
Ethics committee country [1] 288103 0
United States of America
Date submitted for ethics approval [1] 288103 0
Approval date [1] 288103 0
Ethics approval number [1] 288103 0

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

Contacts
Principal investigator
Name 34721 0
Address 34721 0
Country 34721 0
Phone 34721 0
Fax 34721 0
Email 34721 0
Contact person for public queries
Name 17968 0
Rosa Angulo-Barroso
Address 17968 0
Department of Health and Applied Sciences
INEFC, University of Barcelona
Ave de L'Estadi 12-22
08038 Barcelona
Country 17968 0
Spain
Phone 17968 0
+34 93 4255445
Fax 17968 0
+34 93 4263617
Email 17968 0
rangulo@gencat.cat
Contact person for scientific queries
Name 8896 0
Rosa Angulo-Barroso
Address 8896 0
Department of Health and Applied Sciences
INEFC, University of Barcelona
Ave de L'Estadi 12-22
08038 Barcelona
Country 8896 0
Spain
Phone 8896 0
+34 93 4255445
Fax 8896 0
Email 8896 0
rangulo@gencat.cat

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
No additional documents have been identified.