Gait Adaptation for Stroke Patients With Augmented Reality "GASPAR"

Recruiting

Phase N/A Results N/A

Trial Description

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

Detailed Description

After a lesion to the central nervous system, many patients suffer from a diminished walking capability. During the first rehabilitation phase, specific cares help the recovery of motor function to offer the best chances of returning to normal walk. For example, the repeated practice of walking exercises facilitates the gain of muscular strength and stimulates motor relearning. However, in patients, who have finished the first rehabilitation phase, it is often observed strong limping, unsteady gait, and a bad management of obstacle clearance. Thus, these individuals fall frequently, with risk of severe injury. The aim of the study is to assess the efficacy of gait training on a treadmill equipped with an augmented reality system. Shapes are displayed onto the treadmill belt with a projector (beamer): the patient adapts his/her gait to the drawing that unfolds in front of him/her. It is possible to train gait symmetry for coordination enhancement or to exercise obstacle clearance and gait agility. Another advantage of this type of treadmill is the capability to continuously analyze gait with integrated sensors and, hence, to give real-time feedback to the patient. Whereas the method seems promising, thorough studies that would confirm its efficacy are lacking. Therefore, the investigators seek to conduct a randomized controlled trial to compare visually-guided gait training with a more classical training method. During four weeks, participants will train, according to their abilities, three to five times a week during 30 minutes on the augmented-reality treadmill. A group of control patients will train at comparable intensity but without the visual guidance of gait. Using the data collected during the training sessions, the investigators will study whether the evolution of locomotor function differs between both groups. Furthermore, several questionnaires will be filled in by the participants to document the self-evaluation of their progress. In the long term, the investigators expect to first improve the efficacy of gait rehabilitation and second to better understand the recovery process of locomotor function during the first months after a stroke.

Conditions

Interventions

  • Gait training with augmented reality Device
    Intervention Desc: 20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.
    ARM 1: Kind: Experimental
    Label: Augmented reality training
    Description: Gait training with augmented reality
  • Standard training Device
    Intervention Desc: 20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.
    ARM 1: Kind: Experimental
    Label: Standard training
    Description: Gait training without augmented reality

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in walking speed Pre-intervention (week 0), Post-intervention (week 5) No
Secondary Change in postural control Pre-intervention (week 0), Post-intervention (week 5) No
Secondary Fear of falling during the hospitalization week 5 No
Secondary Fear of falling at home after discharge at 3-4 month No
Secondary Quality of life at home after discharge at 3-4 month No
Secondary Perception of the intervention During the intervention, week 2 and 4 No
Secondary Changes in stride and step lengths In every gait training sessions, from week 1 to week 4 No
Secondary Changes in stride and step durations In every gait training sessions, from week 1 to week 4 No
Secondary Change in step width In every gait training sessions, from week 1 to week 4 No
Secondary Change in left/right asymmetry of step lengths In every gait training sessions, from week 1 to week 4 No
Secondary Change in left/right asymmetry of step durations In every gait training sessions, from week 1 to week 4 No
Secondary Changes in stance and swing phases In every gait training sessions, from week 1 to week 4 No
Secondary Change in gait variability In every gait training sessions, from week 1 to week 4 No

Sponsors