BioSpine: multimodal rehabilitation for individuals with complete chronic spinal cord injury

Phase 1

Recruiting

• Conditions: traumatic complete chronic spinal cord injury; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12622001272785
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-28
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

•Motor complete spinal cord injury (based on ASIA Impairment Scale A or B classification)
•Chronic (> 2 years post injury), traumatic spinal cord injury
•Ability to participate in regular physical activity
•Must sign Informed Consent prior to any study related procedures

Exclusion Criteria

•Osteoporosis with a T-Score < -4.0
•Existing selective serotonin reuptake inhibitors (antidepressants), monoamine oxidase inhibitors (antidepressants), or other psychotropic use, unless approved by the participant’s primary physician
•Current amphetamine or recreational drug use
•Fractures in the last 18 months
•History of stem cell therapy in the last 5 years
•Existing baclofen or other antispasmodic use
•Renal impairment
•Hepatic impairment
•Orthopaedic conditions including joint instability
•Pregnancy
•Concurrent significant head injury resulting in psychomotor deficit
•Cognitive impairment that limits capacity
•Epilepsy
•Cardiac pacemakers or defibrillators
•Skin breakdown which would limit ability to sit for 60 minutes
•Any other complications that would prevent participation as determined by the participant’s primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified