ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral Palsy

Non-ambulant

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

This information will be downloaded from the device within one week of completion of the 4-week cycling intervention

Primary outcome [3]

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]

The survey will be completed within one week of completion of the 4-week cycling intervention

Secondary outcome [1]

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]

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?

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

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Melbourne

Address [1]

41 Victoria Parade
Fitzroy VIC 3065

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Murdoch Children's Research Institute

Address [2]

Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3052

Not for Profit
Medical Research Institute

Country [2]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital Melbourne

Address

41 Victoria Parade Fitzroy VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St. Vincent's Hospital Melbourne

Ethics committee address [1]

41 Victoria Parade Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/10/2022

Approval date [1]

09/12/2022

Ethics approval number [1]

St Vincent’s HREC Ref: HREC 245/22

Summary

Brief summary

Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement.  For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds.
The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night.
This study will explore the frequency of use of the MOTOmed within the home, analyse data retrieved from the MOTOmed regarding usage and gain perspectives on the experience and perceived benefits of a home-based motorised cycling intervention.  Those involved in the study will use the MOTOmed a minimum of four times per week over a 4 week period. A questionnaire at the completion of the study will enable participants to provide feedback on how the use of the MOTOmed impacted areas such as muscle tone / spasticity, sleep, mood, level of alertness and interactions with others alongside information on if it is an appropriate method of increasing physical activity and movement, where they would ideally like to access the device and if they would like to continue using it given the opportunity to do so.   Additional information is downloaded from the MOTOmed such as number of spasms, duration and distance covered with each use.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Carlee Holmes

Address

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

Australia

Phone

+61 3 9288 4672

Fax

carlee.holmes@svha.org.au

Contact person for public queries

Name

Carlee Holmes

Address

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

Australia

Phone

+61 3 9288 4672

Fax

carlee.holmes@svha.org.au

Contact person for scientific queries

Name

Carlee Holmes

Address

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

Australia

Phone

+61 3 9288 4672

Fax

carlee.holmes@svha.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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