Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Austin Health | OTHER_GOV |
| Hampstead Rehabilitation Centre Adelaide | UNKNOWN |
| Shenton Park Rehabilitation Centre Perth | UNKNOWN |
| Royal Rehabilitation Centre Sydney |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group participants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with with complete or incomplete spinal cord injury between C6 and T12. A total of 188 participants will be randomised into two groups, the experimental group and the control group. The control group participants will receive an upper body strength and fitness program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental group articipants will receive a comprehensive full body exercise program, conducted for 2-3 hours, three times per week for 12 weeks.
The main objective of this study is to determine if the experimental exercise program is more effective than the upper body strength and fitness program in promoting neurological improvement in participants with spinal cord injury.
Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week treatment period followed by 6 month and 12 month (from baseline) follow up assessments.
Participants will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy, neurophysiological, fitness and functional tests, psychological and quality of life questionnaires, as well as tests of immune function and bone structure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT) using the Therastride Treadmill System, functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower limb exercise. These interventions will be provided at the spinal unit. |
|
| Control Group | Other | Participants in Group B will receive an upper body strength and fitness program. This program may be provided at the spinal unit, or an appropriately equipped gymnasium as approved by the SCIPA Full-On Project Committee. It will be based on the Burn Rubber Burn (BRB) exercise program already established in Sydney. BRB is a circuit-based exercise program incorporating resistance and cardiovascular training. For this protocol, the circuit will comprise several stations using different pieces of equipment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therastride Treadmill System | Device | This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380). |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement. | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof Mary Galea | University of Melbourne | Principal Investigator |
| Prof Glen Davis | University of Sydney | Principal Investigator |
| Prof Sarah Dunlop | The University of Western Australia | Principal Investigator |
| Dr Andrew Nunn | Austin Health | Principal Investigator |
| Dr Tim Geraghty | Princess Alexandra Hospital Brisbane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spinal Unit, Prince of Wales Hospital | Randwick | New South Wales | Australia | |||
| Royal Rehabilitation Centre Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24025260 | Background | Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291. | |
| 35545824 | Result | Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A, Olenko L; SCIPA Switch-On Trial Collaborators<xref ref-type="fn" rid="fn1-1545968318771213" ptype="f1545968318771213" citart="citart1">*</xref>. SCIPA Full-On: A Randomized Controlled Trial Comparing Intensive Whole-Body Exercise and Upper Body Exercise After Spinal Cord Injury. Neurorehabil Neural Repair. 2018 Jun;32(6-7):557-567. doi: 10.1177/1545968318771213. Epub 2018 May 7. |
Not provided
Not provided
Aggregate data only. Individual participant data will not be provided as per the ethics approval.
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
| Prince of Wales Hospital, Sydney | OTHER_GOV |
| Burwood Hospital, Christchurch, New Zealand | OTHER |
Not provided
Not provided
Not provided
Not provided
| FES-assisted cycling | Device | This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD). |
|
| Trunk and upper and lower limb exercises | Other | This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality. |
|
| Upper body strength and fitness program | Other | This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training. |
|
| Sydney |
| New South Wales |
| Australia |
| South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre | Northfield | South Australia | Australia |
| Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre | Kew | Victoria | 3101 | Australia |
| Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital | Shenton Park | Western Australia | Australia |
| Burwood Academy | Christchurch | New Zealand |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided