None listed
Conditions
Brief summary
The study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention. This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury.
Interventions
The study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention.
This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outc
The study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention. This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury. This feasibility trial is a necessary next step toward the anticipated full cell transplantation – rehabilitation clinical trial that the Clem Jones Centre for Neurobiology and Stem Cell Research at Griffith University is working towards and is the next phase after GUSIP02. On-site program will be 2 hours per day plus 30 min of functional electrical stimulation sessions, 5 days per week, for 16 weeks • Standing: 150 min per week (30 min per day, 5 days per week) • Gait training: 90 min per week (30 min per day, 3 days per week) • Upper limb strength: 150 min per week (30 min per day, 5 days per week) • Trunk stability/core strength: 90 min per week (30 min per day, 3 days per week) • Aerobic training: 120 min per week (30 min per day, 4 days per week) • Functional Electrical Stimulation (FES): 150 min per week (30 min per day, 5 days per week) The intervention will take place at a specialised gym: "Making Strides" on the Gold Coast, Queensland. Examples of exercises that will be prescribed as part of each component of the intervention are as follows: • Standing/Weight bearing: Participants will perform load bearing in various setups depending on their level of function including standing frames, bodyweight support supplied via a harness and overhead hoist and manual facilitation. • Gait training can be completed both overground using a 20m track system, as well as on a treadmill. • Upper limb strength: Upper body strengthening: Functional resistance exercises will be prescribed in line with task-specific demands of various activities of daily living. Overhead tasks as well as push and transfer strength are the main focus of these exercises. Push-specific strengthening: Horizontal push-specific strengthening exercises will be incorporated to increase wheelchair propulsion strength and endurance, as well as general completion of Activities of Daily Living (ADLs). Resisted movements that are similar to the motion of wheelchair propulsion will be used for specificity (e.g. hand cycle ergometer, adaptive ski ergometer facing away from machine & cable resisted push motion intervals, as well as flat bench press using progressive overload). Transfer-specific strength: For transfer-specific strength, vertical pushing movements focusing on triceps and pectoral strengthening will be used, as well as scapular depression exercises. • Trunk stability/ core strength: Concentric and isometric core exercises will be prescribed to strengthen muscles involved in various functional movements/postures. • Aerobic training: Aerobic exercises may include arm cycle ergometry, seated ski ergometry, seated boxing (low impact), and seated rope work. Functional Electrical Stimulation (FES): Participants will complete either upper or lower body FES cycle ergometry or a combination of both with a total session capacity of 5 times per week. Pulse width is set at 250pw for all participants and frequency is set at 40Hz. Amplitude ranges from 1-140mA determined by preforming a muscle test on each of the muscle groups (quads, hamstrings and glutes). The program will be personalised to suit each individual’s injury as it is difficult to have a standardised program due to the varied nature of SCI, the variance in function, and the exercise capacity. The exercise program will be tailored to the participant’s level of injury and neurological function/ ambulatory capacity at the discretion of the exercise physiologists and physiotherapists, with examples including reducing the weight and number of repetitions of training exercises or omitting activities/exercises that can’t be performed by the participant. The total intervention time is 16 weeks 'on site' and then there is a follow up with participants at 2 weeks post intervention. The program will be supervised/facilitated by an exercise physiologist. Strategies used to monitor adherence to the intervention are as follows: Participants will complete a Log of Activities every day and exercise physiologists/physiotherapists will also capture participants’ compliance during the program. The mode of delivery will be one-on-one. The cohort of participants at any one time will be a maximum of 5 participants, due to the capacity of the service provider Making Strides.
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion/exclusion criteria for participants have been determined in consultation with medical and rehabilitation specialists including a clinician with a lived experience of SCI. Participants will be included if they: 1. Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent and have completed their primary rehabilitation; 2. Have stable neurological level and functional ability of more than 6 months in duration; 3. Are over 18 years and able to give informed consent; 4. Are ASIA A or B (as per the International Standards for Neurological Classification of spinal cord injury) (documented by an ISNCSCI/ASIA exam performed by a qualified practitioner within the last 6 months); 5. Are able and willing to attend an exercise program five times per week for 16 weeks; 7. Have not exercised more than 2 times a week, 40 weeks a year (or no more than 80 sessions per year), at a SCI recovery or specialist rehabilitation centre in the last two years; 8. Are considered by their general practitioner or specialist medical consultant to be fit to undertake the exercise program (documented approval by general practitioner required).
Exclusion criteria
Participants will not be included if they: 1. Have significant concomitant central nervous system, peripheral nervous system or musculoskeletal system injuries or disorders limiting ability to exercise; 2. Have had recent major trauma or surgery within the last 6 months; 3. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer Advisory Panel classification; 4. Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic or renal bone disease, and senile osteoporosis; 5. Have a medical history of exposure to medication(s) known to affect mineral or bone metabolism; 6. Have significant impairment or disability, including physical, neurological or psychological impairments, additional to the spinal cord injury; 7. Have a history of long bone fracture incompletely healed; 8. Have extensive fixed contractures in the upper or lower limbs; 9. Have severe spasticity; 10. Have uncontrolled neuropathic pain; 11. Have autonomic dysreflexia without a management plan; 12. Are unable to complete the 2-week pre-intervention assessments and the 2-week follow-up assessments; 13. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb fracture or pregnancy; 14. Have any other serious medical condition including malignancies, psychiatric, behavioral or drug dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the protocol; 15. Have symptomatic, radiologically demonstrated, or provocatively demonstrated ischaemic heart disease; 16. Have current thromboembolic disease; 17. Are using illicit drugs; 18. Are participating in other clinical trials (including medication, therapeutic interventions and alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol; 19. Are unable to tolerate the expected exercise load:
Outcome results
None listed