Effect of a soft exosuit on daily life gait performance in people with incomplete spinal cord injury: study protocol for a randomized controlled trial

Trials, 2024 · DOI: https://doi.org/10.1186/s13063-024-08412-2 · Published: August 21, 2024

Spinal Cord Injury Assistive Technology Rehabilitation

Simple Explanation

This study aims to assess how a soft exosuit (Myosuit) impacts the walking ability of individuals with incomplete spinal cord injury (iSCI) in their daily lives. The research will also evaluate the Myosuit's usability and its short-term costs and benefits. Participants will be randomly assigned to either use the Myosuit with training or receive conventional gait training, with walking time monitored to measure the exosuit's effectiveness.

Study Duration

6 weeks home period

Participants

34 people with chronic iSCI

Evidence Level

Level 1: Randomized controlled trial

Key Findings

1
The primary outcome is walking time per day, measured using an activity monitor.
2
Secondary outcomes include gait capacity (10MWT, 6MWT, SCI-FAP), usability (D-SUS and D-QUEST questionnaires), and costs and effects (EQ-5D-5L).
3
The study hypothesizes that the Myosuit will increase daily life gait performance and gait capacity, with satisfactory usability.

Research Summary

This study protocol outlines a randomized controlled trial to investigate the effect of the Myosuit, a soft exosuit, on daily life gait performance in individuals with incomplete spinal cord injury (iSCI). The trial involves 34 participants with chronic iSCI who will be randomized into an intervention group receiving the Myosuit program and a control group receiving conventional gait training, with a subsequent crossover. The primary outcome is walking time per day, assessed using an activity monitor, with secondary outcomes including gait capacity, usability, and cost-effectiveness.

Practical Implications

Improved Ambulation

If the Myosuit is effective, it could lead to a less sedentary lifestyle and reduce secondary complications in people with iSCI.

Rehabilitation Strategies

The study provides insights into the potential of soft exosuits as assistive devices in gait rehabilitation for individuals with iSCI.

Personalized Interventions

The research aims to identify personal characteristics related to improved gait performance with the Myosuit, potentially informing personalized rehabilitation strategies.

Study Limitations

1
Blinding is not feasible due to the nature of the intervention, potentially introducing assessment bias.
2
The study is conducted at a single center, which may limit the generalizability of the findings.
3
Missing data will be handled using listwise deletion, which may introduce bias if data is not missing at random.

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