Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury

Gait rehabilitation is a specific component of physical rehabilitation of persons with
sub-acute or chronic spinal cord injury (SCI). One novel method of gait rehabilitation
involves the use of an overhead support point and a harness. The BWS strategy has been
combined with treadmill-based gait training in recent studies with dramatic results. It is
believed that this form of training may enhance output of a ‘central pattern generator' of
stepping movement from circuitry intrinsic to the patient's spinal cord. However, only
limited attention has been paid to the role that training-induced physical conditioning
might play in mediating functional improvements.

This study will evaluate whether BWS gait training is more effective than conventional
rehabilitation therapy in improving functional gait in patients with neurologically
incomplete spinal cord injury. The study will also compare treadmill-based training to
overground-based training. Treadmill-based training has the inherent advantage of providing
highly rhythmic input to the subject's legs; overground-based training has the inherent
advantage of allowing use of assistive devices and thereby replicating a more ‘natural'
training condition.

Patients with chronic SCI (greater than 1 year post-injury) and patients with sub-acute SCI
(2 to 8 months post-injury) will be evaluated. Patients with chronic SCI will be randomly
assigned to one of 3 groups: body weight support and treadmill-based training, body weight
support and overground training, and conventional rehabilitation therapy. Patients with
sub-acute injury will be randomized to receive either BWS treadmill training or conventional
rehabilitation. Training sessions are typically 1 hour long, with 3 sessions per week for 13
weeks.

All patients will be evaluated with a battery of functional, metabolic, and neurophysiologic
measures prior to the onset of training and during the week after training has been
completed. The primary outcome measure will be average maximum overground walking velocity
without body weight support but with the use of passive assistive devices. Secondary
measures will concentrate on function (balance, mobility), fitness (work capacity, strength,
gait efficiency), and spinal cord neurophysiology (motor conduction, reflex excitability).

Inclusion Criteria for Patients with Chronic Injury:

- Spinal cord injury at or above the T10 spine

- 1 year post injury

- Some volitional movement in one or both limbs (i.e., motor incomplete)

- Ability to stand with limited bracing

- Ability to rise from sit to stand with no more that moderate assistance

Inclusion Criteria for Patients with Subacute Injury:

- Spinal cord injury at or above the T10 spine

- 2 to 8 months post injury

- Volitional movement in at least one lower limb muscle (i.e., motor incomplete),
although may not be capable of unsupported standing or moving from sit-to-stand
without maximal assistance

Exclusion Criteria:

- Fractures at or below T11

- Neoplastic, degenerative, or vascular disorders of the spine or spinal cord

- Significant orthopaedic conditions that would interfere with regular exercise or
rehabilitation therapy

- Decubitus ulcer

- Advanced urinary tract infection

- Medical conditions that increase the probability of having a seizure in response to
single pulse transcranial magnetic stimulation