Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000242628
Ethics application status
Approved
Date submitted
20/02/2023
Date registered
7/03/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
7/03/2023
Date results provided
14/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motorised Movement Therapy in Non-ambulant Adults with Cerebral Palsy: A pilot study utilizing the MOTOmed.
Scientific title
Motorised Movement Therapy in Non-ambulant Adults with Cerebral Palsy: A pilot study utilizing the MOTOmed.
Secondary ID [1] 309027 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 329075 0
Non-ambulant 329076 0
Condition category
Condition code
Neurological 326055 326055 0 0
Other neurological disorders
Musculoskeletal 326129 326129 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 326130 326130 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in a 10-minute trial of the MOTOmed to ensure no adverse responses (pain or behavioural) preventing ongoing participation and to ensure compatibility of their wheelchair with the device.

Eligible participants will take part in a 4-week home motorised cycling intervention.

Participants will be required to use the cycling device a minimum of four times per week. A minimum of 10 minutes per session is the recomended starting duration.

The device is set on the passive mode at 20 revolutions per minute. For participants who are able to engage the cycling device independently the passive mode will be automtically over ridden for the duration of time they are able to cycle independently. The device will convert back to passive mode automatically if they are unable to maintain the independent cycling. It is expected that the majority of participants will remain in the passive mode due to the significant level of disability.

Due to the level of disability of participants, all sessions will be facilitated and supervised by a family member or support worker who will also complete the written diary at the end of each session.

The written diary will include session date and duration (minutes). Satisfaction with each session will be recorded using a 5 point scale and additional comments may be provided on other aspects such as muscle relaxation, function, mood, sleep, willingness to cycle, or other.

In addition, a member of the research team will call the participant / legal guardian weekly to troubleshoot any concerns and provide additional guidance on progression as required. The primary investigator can be contacted during working hours if an issue arises.
Intervention code [1] 325472 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333923 0
Satisfaction with cycling intervention.
This will be assessed using a 5-point scale to indicate their satisfaction with that episode of MOTOmed use.
The diary has a section to indicate if responses were made by the participant or by proxy report.
Timepoint [1] 333923 0
Recorded for each episode of cycling during the 4-week period of intervention.
This will be collected from participants within one week of completion of the 4-week cycling intervention.
Primary outcome [2] 333924 0
Motomed data.
The Motomed cycling device collects and stores data pertaining to each episode of use.
The data for each session includes date, time, active and passive duration (seconds), active and passive speed (revolutions per minute), muscle tone at the start and end of each session (on a contious scale from 0 to 20) and the number of muscles spasms per session.
The motomed data is a composite primary outcome.
Timepoint [2] 333924 0
This information will be downloaded from the device within one week of completion of the 4-week cycling intervention
Primary outcome [3] 334003 0
Qualitative Survey
Designed specifically for this intervention
Information will be collected either via phone or face to face (according to the participant / legal gaurdian's preference)
The survey will contain a combination of fixed choice and open response questions.
Oucomes to be assesed include: satisfaction with the Motomed as a form of physical activity, key advantages and limitations to the use of the Motomed, changes (using a 5 point scale) to pain, fatigue, sleep,muscle stiffness, mood, behaviour, interactions with others, ability to move lower limbs and ability to dress lower limbs following use of the Motomed.
The survey is a composite primary outcome.
Timepoint [3] 334003 0
The survey will be completed within one week of completion of the 4-week cycling intervention
Secondary outcome [1] 418766 0
Subjective responses
An optional comment per cycling session may be recorded. Comments regarding the effect of the session on muscle relaxation, function, mood, level of alertness, sleep, willingness to cycle or other may be recorded on the provided diary.
The diary has a section to indicate if responses were made by the participant or via proxy report.
The subjective responses are a composite secondary outcome.
Timepoint [1] 418766 0
Recorded for each episode of cycling during the 4-week period of intervention.
This will be collected from participants within one week of completion of the 4-week cycling intervention.

Eligibility
Key inclusion criteria
• CP GMFCS IV & V
• Current patient of YACDS or ITB Clinic
• Age 18 years and older
• Interested in increasing physical activity
• Not currently using a cycling machine
• Availability of carers to assist with MOTOmed use on a regular basis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Uncontrolled epilepsy
• Uncontrolled pain
• Presence of contractures preventing a lower limb cycling motion
• Significant dystonia preventing placement and maintenance of lower limbs in position
• Modified Ashworth Scale (MAS) score of 4 (affected parts rigid in flexion or extension (Bohannon and Smith 1987)
• History of non-traumatic lower limb fracture or low trauma fracture
• Surgery or serial casting scheduled during the trial
• Surgery within the prior 6 months unless medically cleared
• Living in a rural location (greater than 60 minutes travel to SVHM)

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will be conducted for all data.
Qualitative data from open ended survey questions will be coded according to content analysis methods

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/02/2023
Date of last participant enrolment
Anticipated
30/10/2023
Actual
1/06/2023
Date of last data collection
Anticipated
1/12/2023
Actual
5/06/2023
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24206 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 39739 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 313235 0
Hospital
Name [1] 313235 0
St Vincent's Hospital Melbourne
Country [1] 313235 0
Australia
Funding source category [2] 313295 0
Other
Name [2] 313295 0
Murdoch Children's Research Institute
Country [2] 313295 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
41 Victoria Parade Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 314969 0
None
Name [1] 314969 0
Address [1] 314969 0
Country [1] 314969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312464 0
St. Vincent's Hospital Melbourne
Ethics committee address [1] 312464 0
Ethics committee country [1] 312464 0
Australia
Date submitted for ethics approval [1] 312464 0
21/10/2022
Approval date [1] 312464 0
09/12/2022
Ethics approval number [1] 312464 0
St Vincent’s HREC Ref: HREC 245/22

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

Contacts
Principal investigator
Name 124762 0
Dr Carlee Holmes
Address 124762 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3052
Country 124762 0
Australia
Phone 124762 0
+61 3 9288 4672
Fax 124762 0
Email 124762 0
[email protected]
Contact person for public queries
Name 124763 0
Carlee Holmes
Address 124763 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3052
Country 124763 0
Australia
Phone 124763 0
+61 3 9288 4672
Fax 124763 0
Email 124763 0
[email protected]
Contact person for scientific queries
Name 124764 0
Carlee Holmes
Address 124764 0
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3052
Country 124764 0
Australia
Phone 124764 0
+61 3 9288 4672
Fax 124764 0
Email 124764 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


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.