Intensive prehabilitation for people living with 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: ACTRN12622001197729
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-07
• Study Completion: 2023-07-07
• Last Update Posted: 27 February 2024

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 will be included if they:

1.Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent and have completed their primary rehabilitation;
2.Have stable neurological level and functional ability of more than 6 months in duration;
3.Are over 18 years and able to give informed consent;
4.Are ASIA A or B (as per the International Standards for Neurological Classification of spinal cord injury) (documented by an ISNCSCI/ASIA exam performed by a qualified practitioner within the last 6 months);
5.Are able and willing to attend an exercise program five times per week for 16 weeks;

7.Have not exercised more than 2 times a week, 40 weeks a year (or no more than 80 sessions per year), at a SCI recovery or specialist rehabilitation centre in the last two years;
8.Are considered by their general practitioner or specialist medical consultant to be fit to undertake the exercise program (documented approval by general practitioner required).

Exclusion Criteria

Participants will not be included if they:
1.Have significant concomitant central nervous system, peripheral nervous system or musculoskeletal system injuries or disorders limiting ability to exercise;
2.Have had recent major trauma or surgery within the last 6 months;
3.Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer Advisory Panel classification;
4.Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic or renal bone disease, and senile osteoporosis;
5.Have a medical history of exposure to medication(s) known to affect mineral or bone metabolism;
6.Have significant impairment or disability, including physical, neurological or psychological impairments, additional to the spinal cord injury;
7.Have a history of long bone fracture incompletely healed;
8.Have extensive fixed contractures in the upper or lower limbs;
9.Have severe spasticity;
10.Have uncontrolled neuropathic pain;
11.Have autonomic dysreflexia without a management plan;
12.Are unable to complete the 2-week pre-intervention assessments and the 2-week follow-up assessments;
13.Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb fracture or pregnancy;
14.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;
15.Have symptomatic, radiologically demonstrated, or provocatively demonstrated ischaemic heart disease;
16.Have current thromboembolic disease;
17.Are using illicit drugs;
18.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;
19.Are unable to tolerate the expected exercise load:

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of delivering an intensive 16-week rehabilitation program in terms of recruitment rate. i.e.<br>willingness of participants to complete the prehabilitation program. <br><br>Method of Assessment: reporting the number of days needed to recruit five participants for the study.<br>[ 2 weeks after completion of the intervention];Identication of barriers and enablers to implementation of the intervention. Method of assessment: x2 focus groups (face-to-face, groups of 5) assessed by qualitative thematic analysis with participants.[ x1 focus group 2 weeks prior to commencement of intervention<br>x1 focus group at 2 weeks post-intervention completion];Feasibility of collecting outcome assessment data. Method of assessment: count the total number of completed surveys and assessments during the trial, compared to what was assigned to be completed[ 2 weeks post intervention completion]