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

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12621000679886
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-03
• Study Completion: 2022-06-17
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Inclusion/exclusion criteria for participants have been determined in consultation with medical and
rehabilitation specialists including a clinician with a lived experience of SCI.

Participants are eligible to be included in the study only if all the following criteria apply:
i. Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent
and have completed their primary rehabilitation;
ii. Have stable neurological level and functional ability of more than 6 months in duration;
iii. Are over 18 years and able to give informed consent;
iv. Are ASIA A or B (as per the International Standards for Neurological Classification of
SCI);
v. Are able and willing to attend an exercise program five times per week for 26 (16 weeks 'on-site' and 10 weeks 'at-home') weeks;
vi. Are considered by their general practitioner or specialist medical consultant to be fit to
undertake the exercise program (documented approval by general practitioner or
specialist medical consultant required).

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
i. Have significant concomitant central nervous system, peripheral nervous system or
musculoskeletal system injuries or disorders limiting ability to exercise;
ii. Have had recent major trauma or surgery within the last 6 months;
iii. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer
Advisory Panel classification;
iv. Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic
or renal bone disease, and senile osteoporosis;
v. Have a medical history of exposure to medication(s) known to affect mineral or bone
metabolism;
vi. Have significant impairment or disability, including physical, neurological or
psychological impairments, additional to the spinal cord injury;
vii. Have a history of long bone fracture incompletely healed;
viii. Have extensive fixed contractures in the upper or lower limbs;
ix. Have severe spasticity;
x. Have uncontrolled neuropathic pain;
xi. Have autonomic dysreflexia without a management plan;
xii. Are unable to attend the 2-week pre-assessment and the 8-week follow-up
assessments;
xiii. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb
fracture or pregnancy;
xiv. Have any other serious medical condition including malignancies, psychiatric,
behavioral 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;
xv. Have symptomatic, radiologically demonstrated, or provocatively demonstrated
ischaemic heart disease;
xvi. Have current thromboembolic disease;
xvii. Are using illicit drugs;
xviii. Are participating in other clinical trials (including medication, therapeutic
interventions and alternative therapies) or taking medications (including herbal
preparations) that are not considered to be standard care as per the protocol;
xix. Are unable to tolerate expected exercise load.

Study & Design

• Study Type: Interventional
• Study Design: Not specified