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Trial record 3 of 12 for:    spinal cord injury AND cycling | Open Studies

SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury (SCIPA Full-On)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Melbourne.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Victorian Neurotrauma Initiative
Life Time Care and Support Authority (NSW)
The University of Western Australia
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT01236976
First received: November 8, 2010
Last updated: August 4, 2011
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Device: Therastride Treadmill System
Device: FES-assisted cycling
Other: Trunk and upper and lower limb exercises
Other: Upper body strength and fitness program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group

Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT), functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower extremity exercise. These interventions will be provided at the spinal unit.

It is neither feasible nor desirable that every participant receives identical intervention because of the expected differences in impairments and activity limitations that he/she experiences. Project staff will use their clinical judgment to select exercises suitable for each participant and to progress them as appropriate. All exercises selected will be documented in the participant source notes.

Device: Therastride Treadmill System
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 has adjustable ergonomic seating for the therapists, a dedicated computer, surge protector, battery backup, custom software and controls, and a closed-loop feedback system. A therapist/assistant is positioned behind the participant to stabilise the pelvis and trunk, and to assist with appropriate weight shifting and hip rotation during the step cycle. Two additional therapists are seated in front of the participant to provide manual assistance for the lower limbs to facilitate knee extension during stance and knee flexion and toe clearance during swing, maintaining appropriate alignment of the limbs. A fourth person controls the treadmill. This system is being used in US universities and rehabilitation facilities throughout North America and is registered with the FDA (Regulation Number 890.5380).
Device: FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD). Surface electrodes will be applied to the quadriceps, gluteal, hamstrings and calf muscles according to a standardized protocol. The pedal cadence will be set to 15-50 rev•min-1. Stimulation intensity will be gradually increased to a maximum of 140 mA with a pulse width of 0.3ms and frequency of 35Hz (Eser et al. 2003; Fornusek & Davis, 2008). Participants will exercise at the maximal power output possible at their level of recovery. Participants will commence with 10 minutes of training and gradually build up to a period of 30 minutes. The frequency, power output at each minute, and training duration will be recorded at each training session.
Other: Trunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality. These may be provided in lying (e.g. supine, prone) and in weight-bearing positions (e.g. kneeling, standing). Task-specific practice of functional tasks, involving moving the upper body over and outside the base of support, will also be undertaken. Participants may also be given exercises in motor imagery, imagining movements of their body
Control Group

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.

The participants will be supervised by a therapist and/or clinical exercise instructor and exercises will be progressed as appropriate to build strength and endurance. Guidelines for the content and delivery of exercises will be clearly outlined in a handbook to ensure standardisation across sites.

Other: Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation
  2. Are 18 years or older and able to give informed consent
  3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
  4. Are able and willing to attend an exercise program 3 times per week for 12 weeks
  5. Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).

Exclusion Criteria:

  1. Have brachial plexus, cauda equina, or peripheral nerve injury
  2. Have had recent major trauma or surgery within the last 6 months
  3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
  4. Are post-menopausal at time of injury (females)
  5. Have BMI at injury falling below lower threshold of healthy adult reference range
  6. Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis
  7. have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
  8. Have chronic systemic diseases, e.g. Hep C, HIV-AIDs
  9. Have significant impairment or disability, including physical, neurological or psychological impairments
  10. Have a history of long bone fracture, or family history of fragility fracture
  11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
  12. Have extensive fixed contractures in upper or lower limbs
  13. Have severe spasticity
  14. Have uncontrolled neuropathic pain
  15. Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
  16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
  17. Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
  18. Have intracranial metal implants (for TMS only)
  19. Have any other serious medical condition including malignancies, psychiatric, behavioural 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.
  20. Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236976

Contacts
Contact: Prof Mary Galea +61 3 9490 7645 m.galea@unimelb.edu.au
Contact: Prof Glen Davis +61 2 9351 9466 Glen.Davis@sydney.edu.au

Locations
Australia, New South Wales
Spinal Unit, Prince of Wales Hospital Not yet recruiting
Randwick, New South Wales, Australia
Contact: Julia Batty    +61 2 9382 5900    julia.batty@sesiahs.health.nsw.gov.au   
Contact: Fernanda Di Natal    +61 2 9382 5900    Fernanda.diNatal@sesiahs.health.nsw.gov.au   
Principal Investigator: Julia Batty         
Sub-Investigator: Fernanda Di Natal         
Royal Rehabilitation Centre Sydney Not yet recruiting
Sydney, New South Wales, Australia
Contact: Sarah Fereday    +61 2 9808 9273    Sarah.Fereday@royalrehab.com.au   
Contact: Clare Goodman    +61 2 9808 9360    clare.goodman@royalrehab.com.au   
Principal Investigator: Sarah Fereday         
Sub-Investigator: Clare Goodman         
Australia, South Australia
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre Recruiting
Northfield, South Australia, Australia
Contact: Ruth Marshall    +61 8 8222 1629    ruth.marshall@health.sa.gov.au   
Contact: Jillian Clark    +61 8 8222 1860    Jillian.Clark@health.sa.gov.au   
Principal Investigator: Ruth Marshall         
Sub-Investigator: Jillian Clark         
Sub-Investigator: Graig Drury         
Australia, Victoria
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre Recruiting
Kew, Victoria, Australia, 3101
Contact: Mary Galea    +61 3 9490 7645    m.galea@unimelb.edu.au   
Contact: Melanie Hurley    +61 9490 7647    mhurley@unimelb.edu.au   
Principal Investigator: Mary Galea         
Sub-Investigator: Andrew Nunn         
Australia, Western Australia
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital Recruiting
Shenton Park, Western Australia, Australia
Contact: John Buchanan    +61 8 9382 7171    John.Buchanan@health.wa.gov.au   
Contact: Kate Wisbey    +61 8 9382 7307    Kate.Wisbey@health.wa.gov.au   
Principal Investigator: John Buchanan         
Sub-Investigator: Sarah Dunlop         
Sub-Investigator: Garry Allison         
New Zealand
Burwood Academy Recruiting
Christchurch, New Zealand
Contact: Jo Nunnerley    +64 03 3836833    Joanne.Nunnerley@cdhb.govt.nz   
Contact: Jacqui Prakasim       Jacqueline.Prakasim@middlemore.co.nz   
Principal Investigator: Rick Acland         
Sub-Investigator: Anne Sinnott         
Sponsors and Collaborators
University of Melbourne
Victorian Neurotrauma Initiative
Life Time Care and Support Authority (NSW)
The University of Western Australia
Investigators
Principal Investigator: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Mary Galea, University of Melbourne
ClinicalTrials.gov Identifier: NCT01236976     History of Changes
Other Study ID Numbers: SCIPA Full-On 
Study First Received: November 8, 2010
Last Updated: August 4, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 27, 2016