Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000203550
Ethics application status
Approved
Date submitted
25/08/2023
Date registered
1/03/2024
Date last updated
1/03/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Walking speed and physical endurance level of adults residing in disability homes.
Scientific title
Normative values of gait speed and endurance assessments among adults in disability homes.
Secondary ID [1] 310464 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual disability 331261 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328015 328015 0 0
Physiotherapy
Neurological 329083 329083 0 0
Other neurological disorders
Mental Health 329084 329084 0 0
Learning disabilities

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be assessed for their performance in 2-minute walk test and 6-minute walk test for endurance (20 minutes) and 4-metre and 10-metre walk test for gait speed (10 minutes). This computes to a total of 30 minutes per participant.
Intervention code [1] 326860 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335880 0
Gait speed: 4-metre test
Timepoint [1] 335880 0
Baseline - during once-off assessment visit.
Primary outcome [2] 336901 0
Gait speed: 10-metre walk test
Timepoint [2] 336901 0
Baseline - during once-off assessment visit.
Primary outcome [3] 336902 0
Endurance: 6-minute walk test
Timepoint [3] 336902 0
Baseline - during once-off assessment visit.
Secondary outcome [1] 425969 0
Endurance: 2-minute walk test (also a primary outcome)
Timepoint [1] 425969 0
Baseline - during once-off assessment visit.

Eligibility
Key inclusion criteria
Residents with intellectual disability and living in the disability/ sheltered home who require minimal physical guidance to ambulate independently.
Minimum age
21 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents with aggression or behavioural issues (e.g unable or unwilling to follow instructions), and requiring constant physical guidance.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2023
Date of last participant enrolment
Anticipated
Actual
3/08/2023
Date of last data collection
Anticipated
Actual
3/08/2023
Sample size
Target
70
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 25727 0
Singapore
State/province [1] 25727 0
Singapore

Funding & Sponsors
Funding source category [1] 314670 0
University
Name [1] 314670 0
Singapore Institute of Technology
Country [1] 314670 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Dr, Singapore 138683, Singapore
Country
Singapore
Secondary sponsor category [1] 316637 0
Charities/Societies/Foundations
Name [1] 316637 0
Thye Hua Kwan Moral Charities
Address [1] 316637 0
150A Mei Chin Road #02-01, Singapore 140150, Singapore
Country [1] 316637 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313689 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 313689 0
10 Dover Dr, Singapore 138683, Singapore
Ethics committee country [1] 313689 0
Singapore
Date submitted for ethics approval [1] 313689 0
03/01/2023
Approval date [1] 313689 0
17/04/2023
Ethics approval number [1] 313689 0
2023002

Summary
Brief summary
In shaping a more inclusive society, care for adults with intellectual disability (ID) is important. Some of these adults are not able to care for themselves independently with risk of falling and thus reside within specialised residential facilities, also known as disability homes in Singapore. Apart from cognitive functioning, the physical capacity of these adults (residents) is important for them to be able to integrate with the community. Gait speed is recognised as the sixth vital sign of a person, while endurance provides an understanding of the physical capacity of a person to function independently in the community. The residents are routinely assessed in clinical tests such as 10-metre walk test and 6-minute walk test among many other tests, but some require modified instructions to complete the test. To our knowledge, there are no studies that explored normative values of adults with ID. Therefore, the primary aims of the study are to establish normative values of 4-metre walk test, 10-metre walk test, 2-minute walk test and 6-minute walk test in adults with intellectual disability. The secondary aims of the study are to investigate the association of the 4-metre walk test with 10-metre walk test, 2-minute walk test with 6-minute walk test in residents living in adult disability homes, and to explore demographic factors of the residents that influence their speed and endurance, as well as differences in speed and endurance between fallers and non-fallers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129022 0
A/Prof Kwok Boon Chong
Address 129022 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683, Singapore
Country 129022 0
Singapore
Phone 129022 0
+6596916703
Fax 129022 0
Email 129022 0
[email protected]
Contact person for public queries
Name 129023 0
Lynn Amelia Hanip
Address 129023 0
150A Mei Chin Road, Thye Hua Kwan Moral Charities, Singapore 140150, Singapore
Country 129023 0
Singapore
Phone 129023 0
+6597992705
Fax 129023 0
Email 129023 0
[email protected]
Contact person for scientific queries
Name 129024 0
Kwok Boon Chong
Address 129024 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683, Singapore
Country 129024 0
Singapore
Phone 129024 0
+6596916703
Fax 129024 0
Email 129024 0
[email protected]

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


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.