Lessons learned from the pilot study of an orthostatic hypotension intervention in the subacute phase following spinal cord injury

The Journal of Spinal Cord Medicine, 2019 · DOI: 10.1080/10790268.2019.1638129 · Published: January 1, 2019

Spinal Cord Injury Cardiovascular Science Rehabilitation

Simple Explanation

This study explores the feasibility of using a combination of a dynamic tilt-table (Erigo®) and functional electrical stimulation (FES) to help people with spinal cord injuries (SCI) who experience drops in blood pressure when they stand up (orthostatic hypotension or OH). The study found that it was difficult to recruit enough patients with SCI and OH for a larger clinical trial, and that the available time for research was limited due to the patients' busy rehabilitation schedules. The researchers suggest that OH might be less common or severe in the subacute phase after SCI than previously thought, and that standard treatments may be enough for most patients.

Study Duration

45 weeks

Participants

2 inpatients with C4-T6 SCI (AIS A-D) less than 12 weeks before recruitment

Evidence Level

Pilot study

Key Findings

1
The recruitment rate for the study was low, with only 2 participants being recruited out of 148 inpatient charts reviewed.
2
Scheduling assessment and intervention sessions was challenging due to limited time available in participants' weekday clinical schedules.
3
Orthostatic hypotension in the subacute phase after SCI was less prevalent and incapacitating than expected.

Research Summary

This pilot study aimed to assess the feasibility of conducting a randomized controlled trial using Erigo® and FES to treat orthostatic hypotension (OH) in subacute SCI patients. The study revealed significant challenges in recruitment due to strict inclusion criteria and the limited availability of eligible patients, as well as difficulties in scheduling interventions within the patients' rehabilitation programs. The findings suggest that OH may be less prevalent and severe in the subacute phase of SCI than previously reported, and that conventional management may be sufficient for many patients, questioning the necessity of additional interventions at this stage.

Practical Implications

Re-evaluate OH Prevalence

The study suggests a need to re-evaluate the prevalence and severity of OH in the subacute phase after SCI to better understand the target population for interventions.

Adapt Clinical Trial Design

Clinical trial designs for SCI rehabilitation should consider the time constraints of inpatient rehabilitation schedules, possibly integrating interventions into existing therapy sessions.

Broaden Inclusion Criteria

Future studies may need to broaden inclusion criteria to increase recruitment rates, while carefully considering the potential impact on study outcomes.

Study Limitations

1
Participants might not be knowledgeable about their condition, particularly early after injury.
2
Measuring blood pressure only once per minute with the automated blood pressure cuff may have resulted in missing transient OH.
3
The Calgary Pre-Syncope Form was selected because it expressed the overall symptomatic state of the person with a single number and verbally

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