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Trial registered on ANZCTR


Registration number
ACTRN12622000814774
Ethics application status
Approved
Date submitted
9/05/2022
Date registered
9/06/2022
Date last updated
9/06/2022
Date data sharing statement initially provided
9/06/2022
Date results provided
9/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate Effect of Enhanced Sensory Inputs on Lower Extremity Muscle Activation Patterns and Stepping Performance During Supported Treadmill Stepping in Infants with Hypotonia
Scientific title
Immediate Effect of Enhanced Sensory Inputs on Lower Extremity Muscle Activation Patterns and Stepping Performance During Supported Treadmill Stepping in Infants with Hypotonia
Secondary ID [1] 305833 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypotonia 324506 0
Condition category
Condition code
Neurological 321985 321985 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention occurred in a laboratory for pediatric motor development of department of physical therapy in a university.

With body weight supported by the researcher, infants stepped on treadmills with enhanced sensory input (that is four different treadmill belt surfaces including normal treadmill, treadmill with visual flow, friction, and sticky) in random sequence.

- “normal”: original treadmill with smooth black belt surface
- “friction”: treadmill belt surface covered with non-slip mats to increase friction, limit sliding of feet on the belt, and induce stepping
- “sticky”: with double sided tape attached to the belt surface, create a condition which is similar with Velcro used in other studies to induce stepping on treadmill
- “visual flow”: smooth treadmill belt surface with black and white checker-board pattern, producing visual flow when the belt is moving

Each infant had to complete these four treadmill sessions in random sequence which was decided in advance:
The researcher arranged 24 possible combination of sequences of the four treadmill sessions, and then randomly sorted these 24 combination of sequences by computer. Finally, according to the sequence of recruitment, infant would be tested for the four treadmill sessions in the sequence of the corresponding sequences sorted by computer.

Treadmills were set to a constant speed of 0.18 m/s. Infants stepped for 45 seconds on each treadmill, and rested for 1 minute between different treadmills. The approximate total duration of the treadmill sessions for each infant was 10 minutes; trials would be stopped if infants kept crying, and continued after infants being comforted, so it may take up to 30 minutes for infants to complete the whole treadmill sessions.

If there were no stepping movements from infants during each treadmill trial, the researcher would guide infants to make stepping movements by patting their lower limbs, driving the lower limbs to step, or shifting the center of gravity. Sitting in front of the treadmills, parents also encourage infants to step by the ways of singing, watching video, playing toys or more. When carrying out “visual flow” treadmill stepping, parents were asked to use toys to induce or encourage infants to look down at the visual flow of the belt surface.

During all the trials, two high-speed cameras, one at right-anterior and another at right-posterior of the treadmill, recorded infants’ stepping. Muscle activation patterns in lower extremities and stepping performance were recorded at the same time during infants' stepping.
Intervention code [1] 323661 0
Treatment: Other
Intervention code [2] 323662 0
Rehabilitation
Comparator / control treatment
The comparator treatment is the normal treadmill surface.
Control group
Active

Outcomes
Primary outcome [1] 329865 0
Muscle activation patterns (including normalized mean amplitude and 16 muscle state analysis) of lower extremities during infants' stepping were recorded using wireless surface electromyography (Trigno Wireless Biofeedback System, Delsys Inc. USA), and then processed using EMGworks® software.

All measures were assessed as a composite primary outcome.
Timepoint [1] 329865 0
During every treadmill stepping trial
Primary outcome [2] 329872 0
Stepping performance (including step types, stepping frequency and kinematics) were recorded and investigated using videos and 3D motion analysis system (Optio Tract, SIMI Reality Motion Systems, German).

All measures were assessed as a composite primary outcome.
Timepoint [2] 329872 0
During every treadmill stepping trial
Secondary outcome [1] 404099 0
Nil
Timepoint [1] 404099 0
Nil

Eligibility
Key inclusion criteria
The infants (1) less than 24 months of corrected age, (2) be able to sit independently for at least 30 seconds, (3) not able to walk independently or have learnt walking independently for less than one month, (4) had been diagnosed with developmental delay, and (5) be assessed as hypotonia.
Minimum age
No limit
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The infants suffer from (1) seizures, (2) visual disabilities, or (3) any other health problems that would limit his/her participation in treadmill stepping trials in this study, such as severe deformities at lower limbs, limited cardiopulmonary function, and skin diseases or sensitivity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS version 24.0 was used for statistical analysis.

For muscle activation patterns: Wilcoxon signed-ranks test was used to check if there were differences between two lower limbs. For the differences of both normalized mean amplitude and 16 muscle state analysis examined when infants stepped on four types of treadmills, Friedmans test was used, and if there was any difference, Wilcoxon signed-ranks test was used for post-hoc test. The significant level of all tests was set at p<0.05.

For stepping performance: Non-parametric Friedmans rank test was used to compare the difference in stepping performance in four treadmill contexts. The significant level was set at P < 0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
15/05/2020
Date of last participant enrolment
Anticipated
Actual
17/12/2020
Date of last data collection
Anticipated
Actual
17/12/2020
Sample size
Target
35
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 24394 0
Taiwan, Province Of China
State/province [1] 24394 0
Taichung City

Funding & Sponsors
Funding source category [1] 310186 0
Self funded/Unfunded
Name [1] 310186 0
Hong-Ji Luo
Country [1] 310186 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Hong-Ji Luo
Address
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112304, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 311273 0
None
Name [1] 311273 0
Nil
Address [1] 311273 0
Nil
Country [1] 311273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309869 0
Institutional Review Board (IRB) of National Yang-Ming University
Ethics committee address [1] 309869 0
Ethics committee country [1] 309869 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 309869 0
08/12/2019
Approval date [1] 309869 0
21/01/2020
Ethics approval number [1] 309869 0
YM108146F

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

Contacts
Principal investigator
Name 115674 0
A/Prof Hong-Ji Luo
Address 115674 0
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112304, Taiwan (R.O.C.)
Country 115674 0
Taiwan, Province Of China
Phone 115674 0
+886228267946
Fax 115674 0
+886228201841
Email 115674 0
hjluo@nycu.edu.tw
Contact person for public queries
Name 115675 0
Hong-Ji Luo
Address 115675 0
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112304, Taiwan (R.O.C.)
Country 115675 0
Taiwan, Province Of China
Phone 115675 0
+886228267946
Fax 115675 0
+886228201841
Email 115675 0
hjluo@nycu.edu.tw
Contact person for scientific queries
Name 115676 0
Hong-Ji Luo
Address 115676 0
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112304, Taiwan (R.O.C.)
Country 115676 0
Taiwan, Province Of China
Phone 115676 0
+886228267946
Fax 115676 0
+886228201841
Email 115676 0
hjluo@nycu.edu.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.