Intensive long-term rehabilitation for people living with chronic spinal cord injury: a feasibility trial

Intervention

Intervention code Rehabilitation , Treatment: Other

The SIP Rehab study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intensive long-term rehabilitation intervention. This trial aims to examine whether long-term intensive rehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia. The feasibility trial will also test whether long-term intensive rehabilitation improves overall health, social outcomes and .... The SIP Rehab study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intensive long-term rehabilitation intervention. This trial aims to examine whether long-term intensive rehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia. The feasibility trial will also test whether long-term intensive rehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury. This feasibility trial is a necessary first 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. The ‘on-site’ program (16 weeks) used in the trial will include: 2 hours per day on site, 5 days per week, with an additional 5x 30 minutes of functional electrical stimulation sessions. The location for the ‘on-site’ portion of the intervention is at a specialised gym: “Making Strides” on the Gold Coast, Queensland. The total weekly ‘on-site’ activities will consist of: • 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 ‘at-home’ program (10 weeks), will include a personalised program involving the following exercises: • Unilateral humeral abduction • Unilateral humeral flexion • Unilateral dumbbell shoulder press • Bilateral dumbbell chest press • Dumbbell assisted sit-up • Short sitting unilateral band row • Plank • Palof press • Dumbbell assisted back extension performed in wheelchair. Each exercise is to be performed at weights prescribed by the Exercise Physiologist. Each exercise is to be performed for 3 sets of 15 reps. The programs, including intensity levels for each participant, will be personalised by qualified exercise physiologists at the service provider (Making Strides) 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. For the ‘on site’ portion of the trial, materials will include: bodyweight support supplied via harness and overhead hoist, rubber resistance bands, 20m track system, squat rack with fixed arm supports, forearm support walking frames, crutches, hand cycle ergometer, adaptive ski ergometer, cable machines, arm cycle ergometry, seated ski ergometry, ropes, functional electrical stimulation, and weights. The ‘at home’ portion of the trial will use weights and rubber resistance bands (supplied). The 'at home' program will be personalised as it is difficult to have a standardised program due to the nature of SCI, the variance in function, and the exercise capacity. For participant safety and reproducibility, as well as to minimise assistance and equipment needs, the exercises listed below will be prescribed to each participant to be performed 5 days each week. Each exercise is to be performed for 3 sets of 15 reps. The mode of delivery will be face-to-face for the ‘on-site’ portion of the trial, and the ‘at-home’ program will be prescribed by the exercise physiologist and will be performed at home, or at a local gym, with weekly 30-minute virtual check ins with exercise physiologists. The 'on-site' program will be completed before the 'at-home' program and the 'at-home' program will begin after the 'on-site' program has been completed. i.e. the programs will be run sequentially. The order of the programs is the same for all participants. Intervention adherence or fidelity will be assessed through the use of a log of activity, recorded by the participant during the whole program, and by the staff at Making Strides during the on-site program. Adherence and Fidelity will be analysed by an independent statistical team. Strategies to maintain or improve fidelity, will be via support of Making Strides staff to motivate and maintain fidelity of participation. For the ‘at-home’ program, Making Strides staff will perform a weekly virtual call with the participant. The total intervention time is 26 weeks (16 weeks 'on site' and 10 weeks 'at home') then there is a follow up with participants at 2 weeks post intervention and 8 weeks post intervention.
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Comparison

Control group Uncontrolled

No control group

Outcomes

Outcome: Feasibility of delivering an intensive 26-week rehabilitation program in terms of recruitment rate. i.e. willingness of participants to complete the rehabilitation program. Method of Assessment: counting the number of people who are successfully recruited for the trial by audit of the study database assembled for the trial.
Timepoint: 8 weeks after the completion of the 'at home' program.

Outcome: Feasibility of collecting outcome assessment data. Method of assessment: count the total number of completed surveys and assessments during the trial, compared to what was assigned to be completed.
Timepoint: Measured at 8 weeks post conclusion of ‘at home’ program

Outcome: Identification of barriers and enablers to implementation of the intervention. Method of assessment: x2 focus groups assessed by qualitative thematic analysis with participants.
Timepoint: x1 focus group 2 weeks prior to commencement of intervention (i.e. 2 weeks prior to start of 'on site' program x1 focus group 8 weeks after conclusion of intervention (i.e. 8 weeks after the conclusion of the 'at home' program.