None listed
Conditions
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. The primary study aim is to investigate the effects of physical activity on cardiometabolic biomarkers in non-ambulant adults with CP. Commonly used measures of increased physical activity such as strength, walking speed and distance are not able to be used in this group of adults. Blood markers offer a way to measure the effects of physical activity with change possible within 1 to 3 months of moderate intensity exercise training in able-bodied individuals. Changes are anticipated to occur in the proposed population as participants are beginning from an extreme low or non-existent level of activity. The secondary study aim is to explore the experience of MMT including any perceived benefits and burdens.
Interventions
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 12-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
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 12-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). Muscle spasms will be recorded weekly. Participants will undergo a series of blood test pre and post intervention and will fill in a series of surveys relating to pain, sleep, fatigue, leg activity and satisfaction. In addition, a member of the research team will call the participant / legal guardian fortnightly 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.
Sponsors
St. Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• CP GMFCS Level 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
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) 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 greater than 60 minutes travel to SVHM Wheelchair and device are incompatible
Outcome results
None listed